TY - JOUR AU - Maybery, Darryl AU - Reupert, Andrea AU - Bartholomew, Catherine AU - Cuff, Rose AU - Duncan, Zoe AU - Foster, Kim AU - Matar, Jodie AU - Pettenuzzo, Laura PY - 2020/6/18 TI - A Web-Based Intervention for Young Adults Whose Parents Have a Mental Illness or Substance Use Concern: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e15626 VL - 9 IS - 6 KW - young adult KW - mental health KW - substance use KW - internet-based intervention N2 - Background: One in 5 young people grow up in a family where one parent has experienced a mental health problem or substance use concern. Compared with their same-aged peers, these youth are at a higher risk of academic failure and acquiring a substance abuse and/or mental health issue. There is a paucity of accessible, age-appropriate interventions that address their needs. Objective: A 6-week, web-based intervention, ?mental illness: supported, preventative, online, targeted? (mi.spot), was developed based on previous research and the competence enhancement model. This paper describes the protocol for a randomized controlled trial and details how the usage, safety, acceptability, and feasibility of the intervention will be determined. Methods: Participants will be recruited through social media and clinician referral. A total of 70 Australians, aged 18 to 25 years, who grew up with parents with a mental illness or substance use concern will participate in a 2-arm parallel randomized controlled trial. The assessment will consist of a baseline measurement and 2 follow-up periods, posttest and 6-week follow-up, using the Mental Health Continuum short form; the Depression, Anxiety, and Stress Scale; the Coping Orientation to Problems Experienced inventory; the General Help Seeking Questionnaire; the Social Connectedness Scale; the Mental Health Literacy Scale; the General Self-Efficacy Scale; and the Attribution of Responsibility for Parental Mental Illness Measure. Impact will be examined at pre, post, and follow-up time periods using analyses of variance that will include a within-subjects factor (time) and a between-subjects factor (intervention/control). Facilitator interviews will ascertain intervention feasibility. Participant interviews will ascertain intervention acceptability. Interview data will be analyzed within a qualitative framework. Usage (data analytics) across site features and several indicators of clinical safety will also be reported. Results: The impact of mi.spot will be examined at pre, post, and follow-up time periods using analyses of variance on each of the measures outlined above. There will be a within-subjects factor (time) and a between-subjects factor (intervention/control). Data analysis will employ the intention-to-treat principle by including all participants in the analyses. Qualitative interview data will be analyzed using interpretative phenomenological analysis along with respondent validation. The Monash University Human Research Ethics Committee (reference number: 2019-18660-30434) approved the trial on April 17, 2019. As of October 2, 2019, 30 participants were enrolled in the control group and 34 participants were enrolled in the intervention group. Result are expected to be submitted for publication in December 2020. Conclusions: Study results will provide reliable evidence on a web-based intervention that has the potential to make a difference to the lives of many vulnerable young adults. Implementation guidelines are needed to embed the intervention in different service sectors. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000335190; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000335190 International Registered Report Identifier (IRRID): DERR1-10.2196/15626 UR - http://www.researchprotocols.org/2020/6/e15626/ UR - http://dx.doi.org/10.2196/15626 UR - http://www.ncbi.nlm.nih.gov/pubmed/32554368 ID - info:doi/10.2196/15626 ER - TY - JOUR AU - Matsumoto, Kazuki AU - Hamatani, Sayo AU - Makino, Takuya AU - Uemura, Taku AU - Suzuki, Futoshi AU - Shinno, Seina AU - Ikai, Tomoki AU - Hayashi, Hiroyuki AU - Sutoh, Chihiro AU - Shimizu, Eiji PY - 2020/6/24 TI - Guided Internet-Based Cognitive Behavioral Therapy in Japanese Patients With Obsessive-Compulsive Disorder: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e18216 VL - 9 IS - 6 KW - internet-based cognitive behavioral therapy KW - cognitive behavioral therapy KW - obsessive-compulsive disorder KW - randomized controlled trial KW - protocol N2 - Background: Cognitive behavioral therapy for obsessive-compulsive disorder has been established, but access to this therapy in Japan is limited. Internet-based cognitive behavioral therapy may improve treatment accessibility and sufficiently improve obsessive-compulsive symptoms. There are few randomized controlled trials examining the effectiveness of internet-based cognitive behavioral therapy in patients with obsessive-compulsive disorder. We designed a randomized controlled trial protocol to assess the effectiveness of guided internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder. Objective: We aimed to develop a protocol for a randomized controlled trial of internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder. Methods: The randomized controlled trial will compare internet-based cognitive behavioral therapy treatment and usual care groups, each consisting of 15 participants (n=30) diagnosed with obsessive-compulsive disorder. We will evaluate the effectiveness of a 12-week intervention. The primary outcome of symptom severity will be measured using the Yale-Brown Obsessive-Compulsive Scale. Secondary outcomes will be assessed with the Obsessive-Compulsive Inventory, Beck Anxiety Inventory, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Working Alliance Inventory-Short Form, and the Euro Qol ? 5 Dimension. All measures will be assessed at weeks 0 (baseline) and 12 (follow-up). In the statistical analysis comparing treatment effects, the least-squares means and their 95% CIs will be estimated by analysis of covariance with the change in total outcomes scores at week 12. All comparisons are planned, and all P values will be two-sided, with values <.05 considered statistically significant. Results: The study will be performed from January 2020 to March 2021, and results are expected to be available in mid-2021. Conclusions: The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan. Trial Registration: University Hospital Medical Information Network (UMIN) 000039375; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044422 International Registered Report Identifier (IRRID): DERR1-10.2196/18216 UR - https://www.researchprotocols.org/2020/6/e18216 UR - http://dx.doi.org/10.2196/18216 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442142 ID - info:doi/10.2196/18216 ER - TY - JOUR AU - Brandt, J. Carl AU - Christensen, Reffstrup Jeanette AU - Lauridsen, T. Jørgen AU - Nielsen, Bo Jesper AU - Søndergaard, Jens AU - Sortsø, Camilla PY - 2020/6/25 TI - Evaluation of the Clinical and Economic Effects of a Primary Care Anchored, Collaborative, Electronic Health Lifestyle Coaching Program in Denmark: Protocol for a Two-Year Randomized Controlled Trial JO - JMIR Res Protoc SP - e19172 VL - 9 IS - 6 KW - type 2 diabetes management KW - digital behavioral coaching KW - lifestyle change KW - health behavior change KW - obesity KW - weight loss KW - interactive advice KW - participant engagement KW - quality of life N2 - Background: Obesity is linked to a number of chronic health conditions, such as type 2 diabetes, heart disease, and cancer, and weight loss interventions are often expensive. Recent systematic reviews concluded that app and web-based interventions can improve lifestyle behaviors and weight loss at a reasonable cost, but long-term sustainability needs to be demonstrated. Objective: This study protocol is for a 2-year randomized controlled trial that aims to evaluate the clinical and economic effects of a primary care, anchored, collaborative, electronic health (eHealth) lifestyle coaching program (long-term Lifestyle change InterVention and eHealth Application [LIVA] 2.0) in obese participants with and without type 2 diabetes. The program?s primary outcome is weight loss. Its secondary outcome is the hemoglobin A1c (HbA1c) level, and its tertiary outcomes are retention rate, quality of life (QOL), and cost effectiveness. Analytically, the focus is on associations of participant characteristics with outcomes and sustainability. Methods: We conduct a multicenter trial with a 1-year intervention and 1-year retention. LIVA 2.0 is implemented in municipalities within administrative regions in Denmark, specifically eight municipalities located within the Region of Southern Denmark and two municipalities located within the Capital Region of Denmark. The participants are assessed at baseline and at 6-, 12-, and 24-month follow-ups. Individual data from the LIVA 2.0 platform are combined with clinical measurements, questionnaires, and participants? usage of municipality and health care services. The participants have a BMI ?30 but ?45 kg/m2, and 50% of the participants have type 2 diabetes. The participants are randomized in an approximately 60:40 manner, and based on sample size calculations on weight loss and intention-to-treat statistics, 200 participants are randomized to an intervention group and 140 are randomized to a control group. The control group is offered the conventional preventive program of the municipality, and it is compared to the intervention group, which follows the LIVA 2.0 in addition to the conventional preventive program. Results: The first baseline assessments have been carried out in March 2018, and the 2-year follow-up will be carried out between March 2020 and April 2021. The hypothesis is that the trial results will demonstrate decreased body weight and that the number of patients who show normalization of their HbA1c levels in the intervention group will be much higher than that in the control group. The participants in the intervention group are also expected to show a greater decrease in their use of glucose-lowering medication and a greater improvement in their QOL when compared with the control group. Operational costs are expected to be lower than standard care, and the intervention is expected to be cost-effective. Conclusions: This is the first time that an app and web-based eHealth lifestyle coaching program implemented in Danish municipalities will be clinically and economically evaluated. If the LIVA 2.0 eHealth lifestyle coaching program is proven to be effective, there is great potential for decreasing the rates of obesity, diabetes, and related chronic diseases. Trial Registration: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915 International Registered Report Identifier (IRRID): DERR1-10.2196/19172 UR - http://www.researchprotocols.org/2020/6/e19172/ UR - http://dx.doi.org/10.2196/19172 UR - http://www.ncbi.nlm.nih.gov/pubmed/32584260 ID - info:doi/10.2196/19172 ER - TY - JOUR AU - Michalsen, Henriette AU - Wangberg, Camilla Silje AU - Hartvigsen, Gunnar AU - Jaccheri, Letizia AU - Muzny, Miroslav AU - Henriksen, André AU - Olsen, Isabel Monica AU - Thrane, Gyrd AU - Jahnsen, Birgitta Reidun AU - Pettersen, Gunn AU - Arntzen, Cathrine AU - Anke, Audny PY - 2020/6/29 TI - Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e19213 VL - 9 IS - 6 KW - intellectual disability KW - physical activity KW - technology KW - mHealth KW - mobile phone KW - goal attainment KW - social support KW - self-efficacy N2 - Background: Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs. Objective: The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs. Methods: The trial uses a randomized controlled design comprising 30 intervention participants and 30 control group participants, aged 16 to 60 years, with sedentary lifestyles or low PA levels. While the controls will receive standard care, the intervention aims to increase the level of PA, measured as steps per day, as the primary outcome. Secondary outcome variables are body mass index, blood pressure, physical performance, social support for PA, self-efficacy in a PA setting, behavior problems, and goal attainment. The intervention involves the delivery of tailored mHealth support, using smartphones or tablets to create structure with focus on the communicative abilities of individual participants. Rewards and feedback are provided in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting, where goal attainment scaling will be used to select the participants? PA goals for the intervention period. All participants will be assessed at baseline, at 3 months, and at 6 months. Results: Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about tailored mHealth to support PA in individuals with intellectual disabilities. Conclusions: We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy, and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs. Trial Registration: ClinicalTrials.gov NCT04079439; https://clinicaltrials.gov/ct2/show/NCT04079439 International Registered Report Identifier (IRRID): PRR1-10.2196/19213 UR - http://www.researchprotocols.org/2020/6/e19213/ UR - http://dx.doi.org/10.2196/19213 UR - http://www.ncbi.nlm.nih.gov/pubmed/32437328 ID - info:doi/10.2196/19213 ER - TY - JOUR AU - Wijnen, M. Ben F. AU - Smit, Filip AU - Uhernik, Ivi?evi? Ana AU - Istvanovic, Ana AU - Dedovic, Jovo AU - Dinolova, Roumyana AU - Nica, Raluca AU - Velickovski, Robert AU - Wensing, Michel AU - Petrea, Ionela AU - Shields-Zeeman, Laura PY - 2020/6/1 TI - Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial?Based Health-Economic Evaluations Embedded in the RECOVER-E Program JO - JMIR Res Protoc SP - e17454 VL - 9 IS - 6 KW - community-based mental health care KW - cost-effectiveness analysis KW - cost-utility analysis KW - economic evaluation KW - mental health N2 - Background: Community-based recovery-oriented mental health services for people with severe mental disorders have not been fully implemented in Bulgaria, Croatia, Macedonia, Montenegro, and Romania. The RECOVER-E project facilitates the implementation of specialized mental health care delivered by setting up services, implementing the services, and evaluating multidisciplinary community mental health teams. The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials. Objective: The aim of this protocol paper is to describe the methodology that will be used for the health-economic evaluation alongside the trials. Methods: Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders). The newly implemented health care system will involve community-based recovery-oriented mental health care (CMHC). At each site, 180 consenting patients will be randomized to either CAU or CMHC. Patient-level outcomes are personal and social functioning and quality-adjusted life years (QALYs). Data on participants? health care use will be collected and corresponding health care costs will be computed. This enables evaluation of health care costs of CMHC as compared with CAU, and these costs can be related to patient-level outcomes (functioning and QALY gains) in health-economic evaluation. Results: Data collection was started in December 2018 (Croatia), February 2019 (Montenegro), April 2019 (Romania), June 2019 (North Macedonia), and October 2019 (Bulgaria). The findings of the outcome evaluations will be reported for each of the five countries separately, and the five trials will be pooled for multilevel analysis on a combined dataset. Conclusions: The results of the health-economic evaluation of the RECOVER-E project will contribute to the growing evidence base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition. Trial Registration: (1) ClinicalTrials.gov NCT03922425 (Bulgaria); https://clinicaltrials.gov/ct2/show/NCT03922425 (2) ClinicalTrials.gov NCT03862209 (Croatia); https://clinicaltrials.gov/ct2/show/NCT03862209 (3) ClinicalTrials.gov NCT03892473 (Macedonia); https://clinicaltrials.gov/ct2/show/NCT03892473 (4) ClinicalTrials.gov NCT03837340 (Montenegro); https://clinicaltrials.gov/ct2/show/NCT03837340 (5) ClinicalTrials.gov NCT03884933 (Romania); https://clinicaltrials.gov/ct2/show/NCT03884933 International Registered Report Identifier (IRRID): DERR1-10.2196/17454 UR - https://www.researchprotocols.org/2020/6/e17454 UR - http://dx.doi.org/10.2196/17454 UR - http://www.ncbi.nlm.nih.gov/pubmed/32476658 ID - info:doi/10.2196/17454 ER - TY - JOUR AU - Bustamante Loyola, Jorge AU - Perez Retamal, Marcela AU - Morgues Nudman, Isabel Monica AU - Maturana, Andres AU - Salinas Gonzalez, Ricardo AU - Cox, Horacio AU - González Mas, Miguel José AU - Muñoz, Lucia AU - Lopez, Lilian AU - Mendiburo-Seguel, Andrés AU - Simó, Sandra AU - Palau Subiela, Pascual AU - Guedeney, Antoine PY - 2020/6/26 TI - Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e17943 VL - 9 IS - 6 KW - social withdrawal KW - preterm KW - early detection KW - interactive guidance KW - emotional stress KW - social development KW - postnatal depression KW - posttraumatic stress N2 - Background: Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. Objective: The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms. Methods: This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale?revised. Results: Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021. Conclusions: This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up. Trial Registration: ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547. International Registered Report Identifier (IRRID): DERR1-10.2196/17943 UR - http://www.researchprotocols.org/2020/6/e17943/ UR - http://dx.doi.org/10.2196/17943 UR - http://www.ncbi.nlm.nih.gov/pubmed/32589156 ID - info:doi/10.2196/17943 ER - TY - JOUR AU - Moore, B. Justin AU - Dilley, R. Joshua AU - Singletary, R. Camelia AU - Skelton, A. Joseph AU - Miller Jr, P. David AU - Heboyan, Vahé AU - De Leo, Gianluca AU - Turner-McGrievy, Gabrielle AU - McGrievy, Matthew AU - Ip, H. Edward PY - 2020/6/5 TI - A Clinical Trial to Increase Self-Monitoring of Physical Activity and Eating Behaviors Among Adolescents: Protocol for the ImPACT Feasibility Study JO - JMIR Res Protoc SP - e18098 VL - 9 IS - 6 KW - physical activity KW - obesity KW - adolescence KW - adult KW - therapy, family KW - mobile phone N2 - Background: Severe obesity among youths (BMI for age?120th percentile) has been steadily increasing. The home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during weight loss interventions, which highlights that a family-based treatment approach is warranted. This strategy has been successful in our existing evidence-based pediatric weight management program, Brenner Families in Training (Brenner FIT). However, this program relies on face-to-face encounters, which are limited by the time constraints of the families enrolled in treatment. Objective: This study aims to refine and test a tailored suite of mobile health (mHealth) components to augment an existing evidence-based pediatric weight management program. Methods: Study outcomes will include acceptability from a patient and clinical staff perspective, feasibility, and economic costs relative to the established weight management protocol alone (ie, Brenner FIT vs Brenner FIT + mHealth [Brenner mFIT]). The Brenner mFIT intervention will consist of 6 mHealth components designed to increase patient and caregiver exposure to Brenner FIT programmatic content including the following: (1) a mobile-enabled website, (2) dietary and physical activity tracking, (3) caregiver podcasts (n=12), (4) animated videos (n=6) for adolescent patients, (5) interactive messaging, and (6) in-person tailored clinical feedback provided based on a web-based dashboard. For the study, 80 youths with obesity (aged 13-18 years) and caregiver dyads will be randomized to Brenner FIT or Brenner mFIT. All participants will complete baseline measures before randomization and at 3- and 6-month follow-up points. Results: This study was approved by the Institutional Review Board in July 2019, funded in August 2019, and will commence enrollment in April 2020. The results of the study are expected to be published in the fall/winter of 2021. Conclusions: The results of this study will be used to inform a large-scale implementation-effectiveness clinical trial. International Registered Report Identifier (IRRID): PRR1-10.2196/18098 UR - https://www.researchprotocols.org/2020/6/e18098 UR - http://dx.doi.org/10.2196/18098 UR - http://www.ncbi.nlm.nih.gov/pubmed/32348291 ID - info:doi/10.2196/18098 ER - TY - JOUR AU - Wong, S. Rosa AU - Tung, TS Keith AU - Wong, Tung Hiu AU - Ho, KW Frederick AU - Wong, Sang Hing AU - Fu, King-Wa AU - Pong, Chuen Ting AU - Chan, Ling Ko AU - Chow, Bong Chun AU - Ip, Patrick PY - 2020/6/12 TI - A Mobile Game (Safe City) Designed to Promote Children?s Safety Knowledge and Behaviors: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e17756 VL - 9 IS - 6 KW - serious game KW - safety training KW - mobile game KW - mobile phone KW - injury prevention KW - randomized controlled trial KW - game-based intervention N2 - Background: Children have high levels of curiosity and eagerness to explore. This makes them more vulnerable to danger and hazards, and they thus have a higher risk of injury. Safety education such as teaching safety rules and tips is vital to prevent children from injuries. Although game-based approaches have the potential to capture children?s attention and sustain their interest in learning, whether these new instructional approaches are more effective than traditional approaches in delivering safety messages to children remains uncertain. Objective: The aim of this study is to test the effectiveness of a game-based intervention in promoting safety knowledge and behaviors among Hong Kong school children in Grades 4-6. It will also examine the potential effect of the game-based intervention on these children?s functioning and psychosocial difficulties. Methods: This study comprises the development of a city-based role-playing game Safe City, where players are immersed as safety inspectors to prevent dangerous situations and promote safety behavior in a virtual city environment. The usability and acceptability tests will be conducted with children in Grades 4-6 who will trial the gameplay on a mobile phone. Adjustments will be made based on their feedback. A 4-week randomized controlled trial with children studying in Grades 4-6 in Hong Kong elementary schools will be conducted to assess the effectiveness of the Safe City game?based intervention. In this trial, 504 children will play Safe City, and 504 children will receive traditional instructional materials (electronic and printed safety information). The evaluation will be conducted using both child self-report and parent proxy-report data. Specifically, child safety knowledge and behaviors will be assessed by a questionnaire involving items on knowledge and behaviors, respectively, for home safety, road safety, and sport-related safety; child functioning will be assessed by PedsQL Generic Core Scales; and psychosocial difficulties will be assessed by the Strength and Difficulties Questionnaire. These questionnaires will be administered at 3 time points: before, 1 month, and 3 months after the intervention. Game usage statistics will also be reviewed. Results: This project was funded in September 2019. The design and development of the Safe City game are currently under way. Recruitment and data collection will begin from September 2020 and will continue up to March 1, 2021. Full analysis will be conducted after the end of the data collection period. Conclusions: If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public. Trial Registration: ClinicalTrials.gov NCT04096196; https://clinicaltrials.gov/ct2/show/NCT04096196 International Registered Report Identifier (IRRID): PRR1-10.2196/17756 UR - http://www.researchprotocols.org/2020/6/e17756/ UR - http://dx.doi.org/10.2196/17756 UR - http://www.ncbi.nlm.nih.gov/pubmed/32530436 ID - info:doi/10.2196/17756 ER - TY - JOUR AU - Nelson, E. LaRon AU - Ajiboye, Wale AU - Djiadeu, Pascal AU - Odhiambo, J. Apondi AU - Pedersen, Cheryl AU - Ramos, Raquel S. AU - Lofters, Aisha AU - Mbuagbaw, Lawrence AU - Williams, Geoffrey PY - 2020/6/15 TI - A Web-Based Intervention to Reduce Decision Conflict Regarding HIV Pre-Exposure Prophylaxis: Protocol for a Clinical Trial JO - JMIR Res Protoc SP - e15080 VL - 9 IS - 6 KW - pre-exposure prophylaxis KW - PrEP KW - HIV KW - blacks KW - prevention KW - smartphone KW - mobile phone N2 - Background: HIV pre-exposure prophylaxis (PrEP) is recommended for populations at high ongoing risk for infection. There are noted racial disparities in the incidence of HIV and other sexually transmitted infections (STIs) for African, Caribbean, and Canadian Black (ACB, black) populations in Ontario, Canada. Although blacks represent only 4.7% of the Ontario population, they account for 30% of HIV prevalence and 25% of new infections in the province. The existing clinical public health practice toolkit has not been sufficient to optimize PrEP uptake, despite the overwhelming evidence of PrEP?s efficacy for reducing HIV transmission risk. Since its establishment as an effective HIV prevention tool, the major focus in behavioral research on PrEP has been on understanding and improving adherence. To date, there is no known formalized intervention in place designed to support ACB men and women at high risk of making high-quality decisions regarding the adoption of PrEP as an HIV prevention practice. Objective: We propose 2 aims to address these gaps in HIV prevention and implementation science. First, the Ottawa Decision Support Framework (ODSF) for use in the PrEP decisional needs of black patients was adapted. Second, the decision support intervention to estimate effect size compared with control conditions in reducing decision conflict and predicting adherence over 60 days was pilot tested. Methods: In aim 1, we propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with eligible PrEP patients (n=30) and surveys with health professionals (n=20) involved in HIV PrEP management. Data obtained from aim 1 will be used to develop a decision support intervention based on the ODSF. In aim 2, the adopted decision support intervention using a block-randomized design to estimate effect size compared with control conditions in reducing decision conflict and predicting adherence over 60 days was pilot tested. Hypothesis testing will be de-emphasized in favor of generating effect size estimates. Results: A research award was funded on March 25, 2017 (Multimedia Appendix 1). Ethical approval was received on March 25, 2019 (with supplemental approval received on May 10, 2019). Data collection started on April 9, 2019. As of September 30, 2019, we enrolled 29 patients and 24 health care providers for aim 1. We are currently analysing the data collected for aim 1. Aim 2 is scheduled to start in May 2020. Conclusions: This study will provide evidence-based information on the decisional needs of black patients who are at risk of HIV and have been offered PrEP. The study will also test the effect of decision support intervention in reducing decision conflict, adoption of PrEP, and adherence to PrEP. International Registered Report Identifier (IRRID): PRR1-10.2196/15080 UR - https://www.researchprotocols.org/2020/6/e15080 UR - http://dx.doi.org/10.2196/15080 UR - http://www.ncbi.nlm.nih.gov/pubmed/32348250 ID - info:doi/10.2196/15080 ER - TY - JOUR AU - Duthely, M. Lunthita AU - Sanchez-Covarrubias, P. Alex AU - Mohamed, B. Adhar AU - Potter, E. JoNell PY - 2020/6/19 TI - A Multilingual, Culturally Competent Mobile Health Intervention to Improve Treatment Adherence Among Women Living With HIV: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e17656 VL - 9 IS - 6 KW - telemedicine KW - HIV KW - acquired immunodeficiency syndrome KW - women KW - adherence KW - clinical trial protocol KW - barriers KW - facilitators KW - text messaging KW - mHealth KW - SMS/texting N2 - Background: Adherence to HIV care is complex, as barriers to care are multidimensional, particularly for ethnic minority women. Mobile health (mHealth) solutions are supportive in improving HIV health care outcomes. In the United States, however, mHealth interventions are not widely implemented in public HIV clinics and have not been customized for women. There is an unmet need for culturally and linguistically appropriate mHealth interventions that address the health care needs of minority women living with HIV. Objective: This study aims to describe a protocol investigating the feasibility of an mHealth intervention for treatment adherence among women living with HIV. This is a two-phase, mixed methods, pilot randomized controlled trial that begins with qualitative patient interviews to inform the system design. Participants will be block randomized by language (English, Spanish, and Haitian Creole) to 1 of 2 study arms. Methods: Women (age ?18 years) who were followed up at the women?s HIV clinic of an academic medical center, with a recent history of nonadherence to HIV care (missed appointments, unsuppressed viral load, or not taking medications as prescribed), will be enrolled. The experimental arm will receive the intervention, which includes health reminders and psychoeducational messaging, plus clinical standard of care reminders. The psychoeducational messaging will target patient-level barriers of HIV stigma and medical mistrust and resilience as a patient-level strength. The control arm will receive standard of care reminders only (ie, mailed appointments and automated telephone calls). All aspects of the study and intervention will be offered in the participants? preferred language. The primary outcome is the feasibility and acceptability of the study. The secondary outcomes are changes in self-reported medication adherence, depression symptoms, HIV stigma, medical mistrust, resilience, and clinic attendance and viral suppression extracted from the participants? medical records. Data will be assessed at baseline (T0) and 2 subsequent clinic visits?approximately 3 to 4 months from the baseline (time 1; T1) and 6 to 9 months from the baseline (time 2; T2). Qualitative data will be transcribed and analyzed iteratively. Bivariate analyses will compare data by the study group (chi-square, odds ratios, and t tests). Exploratory analyses will be conducted for each outcome variable?T1 and T2 values will be compared with values at T0 by the study group. Results: As of March 2020, baseline quantitative data were collected on 54 participants (28 English speakers, 14 Spanish speakers, and 12 Haitian Creole speakers). The first 3 focus groups (1 in each of the 3 languages) were completed, with a total of 20 participants. The findings are currently being integrated into the beta version of the mHealth texting system. Conclusions: The findings of this novel HIV adherence intervention may shed light on the barriers and facilitators of HIV health care and the mechanisms of an mHealth intervention that is customized for ethnic minority women living with HIV. Trial Registration: ClinicalTrials.gov NCT03738410; https://clinicaltrials.gov/ct2/show/NCT03738410 International Registered Report Identifier (IRRID): DERR1-10.2196/17656 UR - http://www.researchprotocols.org/2020/6/e17656/ UR - http://dx.doi.org/10.2196/17656 UR - http://www.ncbi.nlm.nih.gov/pubmed/32438338 ID - info:doi/10.2196/17656 ER - TY - JOUR AU - Pastor, Núria AU - Khalilian, Elizabeth AU - Caballeria, Elsa AU - Morrison, Danielle AU - Sanchez Luque, Unai AU - Matrai, Silvia AU - Gual, Antoni AU - López-Pelayo, Hugo PY - 2020/6/24 TI - Remote Monitoring Telemedicine (REMOTE) Platform for Patients With Anxiety Symptoms and Alcohol Use Disorder: Protocol for a Case-Control Study JO - JMIR Res Protoc SP - e16964 VL - 9 IS - 6 KW - digital health KW - digital biomarkers KW - digital phenotype KW - mental health N2 - Background: Monitoring mental health outcomes has traditionally been based on heuristic decisions, often based on scarce, subjective evidence, making the clinical decisions made by professionals, as well as the monitoring of these diseases, subject to flaws. However, the digital phenotype, which refers to the analysis of data collected by measuring human behavior with mobile sensors and smart bracelets, is a promising tool for filling this gap in current clinical practice. Objective: The objectives of this study are to develop the digital phenotyping of patients with alcohol use disorder and anxiety symptoms using data collected from a mobile device (ie, smartphone) and a wearable sensor (ie, Fitbit) and to analyze usability and patient satisfaction with the data collection service provided by the app. Methods: We propose to conduct a study among a group of 60 participants split into two subgroups?experimental and control?of 30 participants each. The experimental group will be recruited by physicians from the Hospital Clínic de Barcelona, and the control group will be recruited on a volunteer basis through fliers and social media. All participants will go through pretraining to ensure technological capability and understanding of tasks, then each participant will download the HumanITcare app and will be given a wearable sensor (ie, Fitbit). Throughout the 4-month period, participants will be monitored on a range of factors, including sleep cycle, heart rate, movement patterns, and sociability. All data from the wearable sensors and the mobile devices will be saved and sent to the HumanITcare server. Participants will be asked to complete weekly questionnaires about anxiety, depression, and alcohol use disorder symptoms. Research assistants will ensure timely responses. The data from both sensors will then be compared to the questionnaire responses to determine how accurately the devices can predict the same symptoms. Results: The recruitment phase was completed in November 2019 and all the data were collected by the end of December 2019. Data are being processed; this process is expected to be completed by October 2020. Conclusions: This study was created and conducted as a pilot study with the Hospital Clínic de Barcelona, with the purpose of exploring the feasibility of our approach. The study is focused on patients diagnosed with anxiety and alcohol use disorder, but participants were also monitored for depressive symptoms throughout the trial, although these were not part of the initial inclusion criteria. A limitation to our study was the exclusive use of Android smartphones over iOS devices; this could result in a potential selection bias, due to the accessibility and affordability of Android phones as opposed to iOS-based phones. Another limitation might be that reviews of usability and satisfaction could be confounded by factors such as age and familiarity. An additional function that we might add in future studies is the ability for patients to manage their own data. International Registered Report Identifier (IRRID): DERR1-10.2196/16964 UR - https://www.researchprotocols.org/2020/6/e16964 UR - http://dx.doi.org/10.2196/16964 UR - http://www.ncbi.nlm.nih.gov/pubmed/32579124 ID - info:doi/10.2196/16964 ER - TY - JOUR AU - Mationg, S. Mary Lorraine AU - Williams, M. Gail AU - Tallo, L. Veronica AU - Olveda, M. Remigio AU - Aung, Eindra AU - Alday, Portia AU - Reñosa, Donald Mark AU - Daga, Mae Chona AU - Landicho, Jhoys AU - Demonteverde, Paz Maria AU - Santos, Dianne Eunice AU - Bravo, Andrea Thea AU - Angly Bieri, A. Franziska AU - Li, Yuesheng AU - Clements, A. Archie C. AU - Steinmann, Peter AU - Halton, Kate AU - Stewart, E. Donald AU - McManus, P. Donald AU - Gray, J. Darren PY - 2020/6/25 TI - Determining the Impact of a School-Based Health Education Package for Prevention of Intestinal Worm Infections in the Philippines: Protocol for a Cluster Randomized Intervention Trial JO - JMIR Res Protoc SP - e18419 VL - 9 IS - 6 KW - soil-transmitted helminths KW - school-based health educational intervention KW - Magic Glasses KW - integrated control KW - randomized controlled trial KW - Philippines N2 - Background: Repeated mass drug administration (MDA) of antihelminthics to at-risk populations is still the main strategy for the control of soil-transmitted helminth (STH) infections. However, MDA, as a stand-alone intervention, does not prevent reinfection. Accordingly, complementary measures to prevent STH reinfection, such as health education and improved sanitation, as part of an integrated control approach, are required to augment the effectiveness of MDA for optimal efficiency and sustainability. Objective: The aim of this study is to determine the impact and generalizability of a school-based health education package entitled The Magic Glasses for STH prevention in the Philippines. Methods: We conducted a cluster randomized controlled intervention trial, involving 2020 schoolchildren aged 9-10 years, in 40 schools in Laguna Province, Philippines, to evaluate the impact of the school-based health education package for the prevention of STHs. The trial was conducted over the course of 1 year (June 2016 to July 2017). A total of 20 schools were randomly assigned to the intervention arm, in which The Magic Glasses Philippines health education package was delivered with the standard health education activities endorsed by the Philippines Department of Health (DOH) and the Department of Education (DepEd). The other 20 schools comprised the control arm of the study, where the DOH/DepEd?s standard health education activities were done. At baseline, parasitological assessments and a knowledge, attitude, and practice survey were carried out in all schools. In addition, height, weight, and hemoglobin levels were obtained from each child (after parental consent), and their school attendance and academic performance in English and mathematics were accessed from the school records. The baseline and 2 follow-up surveys were completed using the same study measurements and quality-control assessments. Results: Key results from this cluster randomized intervention trial will shed light on the impact that The Magic Glasses health education package will have against STH infections in schoolchildren in the province of Laguna, located on the Island of Luzon, in the Calabarzon Region of the Philippines. Conclusions: The results of the trial will be used to assess the generalizability of the impact of The Magic Glasses health education package in different epidemiological and cultural settings, providing evidence for translation of this health education package into public health policy and practice in the Asian region and beyond. Trial Registration: Australian New Zealand Clinical Trials Registry number ACTRN12616000508471; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368849 International Registered Report Identifier (IRRID): DERR1-10.2196/18419 UR - https://www.researchprotocols.org/2020/6/e18419 UR - http://dx.doi.org/10.2196/18419 UR - http://www.ncbi.nlm.nih.gov/pubmed/32584263 ID - info:doi/10.2196/18419 ER - TY - JOUR AU - Ritchie, D. Natalie AU - Holtrop, Summers Jodi AU - Gritz, Mark R. AU - Sauder, Ann Katherine AU - Durfee, Josh Michael AU - Dickinson, Miriam L. AU - Kaufmann, G. Peter PY - 2020/6/1 TI - Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e15499 VL - 9 IS - 6 KW - type 2 diabetes KW - prevention KW - weight loss KW - diabetes mellitus, type 2 KW - cohort studies KW - self efficacy KW - vulnerable populations N2 - Background: Type 2 diabetes affects 9.4% of US adults with higher rates among racial and ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a nonrandomized cohort study among 1140 racially diverse, predominately low-income participants. A total of 75 presession participants had doubled attendance and weight loss as compared with earlier participants who did not receive presessions. On the basis of these promising results, we are conducting a randomized controlled trial (RCT) to determine whether pre-NDPP reliably improves NDPP outcomes, as reported on ClinicalTrials.gov. Objective: This study aims to (1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care), (2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race and ethnicity; income level), and (3) evaluate implementation factors, including cost and projected return on investment. Methods: This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive pre-NDPP versus direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future pre-NDPP dissemination and implementation, including cost. Our primary research question is whether pre-NDPP improves NDPP attendance and weight loss compared with standard NDPP delivery. Results: This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants began the intervention in October 2019. Data analysis and results reporting are expected to be completed in 2024. Conclusions: This RCT of pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent type 2 diabetes across the country. Trial Registration: ClinicalTrials.gov NCT04022499; https://clinicaltrials.gov/ct2/show/NCT04022499. International Registered Report Identifier (IRRID): PRR1-10.2196/15499 UR - https://www.researchprotocols.org/2020/6/e15499 UR - http://dx.doi.org/10.2196/15499 UR - http://www.ncbi.nlm.nih.gov/pubmed/32476659 ID - info:doi/10.2196/15499 ER - TY - JOUR AU - Vaillancourt, Christian AU - Charette, Manya AU - Taljaard, Monica AU - Thavorn, Kednapa AU - Hall, Elizabeth AU - McLeod, Brent AU - Fergusson, Dean AU - Brehaut, Jamie AU - Graham, Ian AU - Calder, Lisa AU - Ramsay, Tim AU - Tugwell, Peter AU - Kelly, Peter AU - Cheskes, Sheldon AU - Saskin, Refik AU - Plint, Amy AU - Osmond, Martin AU - Macarthur, Colin AU - Straus, Sharon AU - Rochon, Paula AU - Prud'homme, Denis AU - Dahrouge, Simone AU - Marlin, Susan AU - Stiell, G. Ian PY - 2020/6/1 TI - Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial JO - JMIR Res Protoc SP - e16966 VL - 9 IS - 6 KW - cervical spine injury KW - Canadian C-Spine rule KW - immobilization KW - paramedic KW - trauma N2 - Background: Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs). Less than 1.0% (1/100) of these patients have a neck bone fracture. Even less (1/200, 0.5%) have a spinal cord injury or nerve damage. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, cervical collar, and head immobilizers. Importantly, prolonged immobilization is often unnecessary; it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly. We therefore developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury. We successfully taught Ottawa paramedics to use the CCR in the field in a single-center study. Objective: This study aimed to improve patient care and health system efficiency and outcomes by allowing paramedics to assess eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED. Methods: We propose a pragmatic stepped-wedge cluster randomized design with health economic evaluation, designed collaboratively with knowledge users. Our 36-month study will consist of a 12-month setup and training period (year 1), followed by the stepped-wedge trial (year 2) and a 12-month period for study completion, analyses, and knowledge translation. A total of 12 Ontario paramedic services of various sizes distributed across the province will be randomly allocated to one of three sequences. Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention. Data will be collected on all eligible patients in each paramedic service for a total duration of 12 months. A major strength of our design is that each community will have implemented the CCR by the end of the study. Results: Interim results are expected in December 2019 and final results in 2020. If this multicenter trial is successful, we expect the Ontario Ministry of Health will recommend that paramedics evaluate all eligible patients with the CCR in the Province of Ontario. Conclusions: We conservatively estimate that in Ontario, more than 60% of all eligible trauma patients (300,000 annually) could be transported safely and comfortably, without c-spine immobilization devices. This will significantly reduce patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care. This could be achieved rapidly and with lower health care costs compared with current practices (possible cost saving of Can $36 [US $25] per immobilization or Can $10,656,000 [US $7,335,231] per year). Trial Registration: ClinicalTrials.gov NCT02786966; https://clinicaltrials.gov/ct2/show/NCT02786966. International Registered Report Identifier (IRRID): DERR1-10.2196/16966 UR - https://www.researchprotocols.org/2020/6/e16966 UR - http://dx.doi.org/10.2196/16966 UR - http://www.ncbi.nlm.nih.gov/pubmed/32348267 ID - info:doi/10.2196/16966 ER - TY - JOUR AU - Mitchell, Jane Marijke AU - Newall, Helen Fiona AU - Sokol, Jennifer AU - Williams, Jane Katrina PY - 2020/6/4 TI - Simulation-Based Education for Staff Managing Aggression and Externalizing Behaviors in Children With Autism Spectrum Disorder in the Hospital Setting: Pilot and Feasibility Study Protocol for a Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e18105 VL - 9 IS - 6 KW - feasibility studies KW - autism spectrum disorder KW - intellectual disability KW - high-fidelity simulation training KW - pediatric nursing KW - child KW - adolescent KW - aggression N2 - Background: Children with autism spectrum disorder (ASD) frequently demonstrate aggression and externalizing behaviors in the acute care hospital environment. Pediatric acute care nursing staff are often not trained in managing aggression and, in particular, lack confidence in preventing and managing externalizing behaviors in children with ASD. High-fidelity simulation exercises will be used in this study to provide deliberate practice for acute care pediatric nursing staff in the management of aggressive and externalizing behaviors. Objective: The purpose of this study is to conduct a pilot and feasibility cluster randomized controlled trial (RCT) to evaluate the effectiveness of simulation-based education for staff in managing aggression and externalizing behaviors of children with ASD in the hospital setting. Methods: This study has a mixed design, with between-group and within-participant comparisons to explore the acceptability and feasibility of delivering a large-scale cluster RCT. The trial process, including recruitment, completion rates, contamination, and completion of outcome measures, will be assessed and reported as percentages. This study will assess the acceptability of the simulation-based training format for two scenarios involving an adolescent with autism, with or without intellectual disability, who displays aggressive and externalizing behaviors and the resulting change in confidence in managing clinical aggression. Two pediatric wards of similar size and patient complexity will be selected to participate in the study; they will be randomized to receive either simulation-based education plus web-based educational materials or the web-based educational materials only. Change in confidence will be assessed using pre- and posttraining surveys for bedside nursing staff exposed to the training and the control group who will receive the web-based training materials. Knowledge retention 3 months posttraining, as well as continued confidence and exposure to clinical aggression, will be assessed via surveys. Changes in confidence and competence will be compared statistically with the chi-square test using before-and-after data to compare the proportion of those who have high confidence between the two arms at baseline and at follow-up. The simulation-based education will be recorded with trained assessors reviewing participants? abilities to de-escalate aggressive behaviors using a validated tool. This data will be analyzed using mean values and SDs to understand the variation in performance of individuals who undertake the training. Data from each participating ward will be collected during each shift for the duration of the study to assess the number of aggressive incidents and successful de-escalation for patients with ASD. Total change in Code Grey activations will also be assessed, with both datasets analyzed using descriptive statistics. Results: This study gained ethical approval from The Royal Children's Hospital Melbourne Human Research Ethics Committee (HREC) on November 1, 2019 (HREC reference number: 56684). Data collection was completed in February 2020. Data analysis is due to commence with results anticipated by August 2020. Conclusions: We hypothesize that this study is feasible to be conducted as a cluster RCT and that simulation-based training will be acceptable for acute care pediatric nurses. We anticipate that the intervention ward will have increased confidence in managing clinical aggression in children with ASD immediately and up to 3 months posttraining. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000139976; http://www.ANZCTR.org.au/ACTRN12620000139976.aspx International Registered Report Identifier (IRRID): DERR1-10.2196/18105 UR - http://www.researchprotocols.org/2020/6/e18105/ UR - http://dx.doi.org/10.2196/18105 UR - http://www.ncbi.nlm.nih.gov/pubmed/32495742 ID - info:doi/10.2196/18105 ER - TY - JOUR AU - Brandao, Maia Joana AU - Sichieri, Rosely AU - Ribas, Augusta Simone AU - Verly-Jr, Eliseu AU - Pereira, Alves Rosangela AU - Castro, De Inês Rugani Ribeiro AU - Hassan, Kulik Bruna AU - Oliveira, De Alessandra Silva Dias AU - Marques, Souza Emanuele AU - Cunha, Barbosa Diana PY - 2020/6/8 TI - Treatment of Childhood Obesity Based on Brazilian Dietary Guidelines Plus Energy Restriction (PAPPAS HUPE Study): Protocol for a Randomized Clinical Trial JO - JMIR Res Protoc SP - e16170 VL - 9 IS - 6 KW - pediatric obesity KW - clinical trial KW - food guide N2 - Background: The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption. Objective: The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake. Methods: A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference. Results: This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in November 2020. Conclusions: At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected. Trial Registration: Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn International Registered Report Identifier (IRRID): DERR1-10.2196/16170 UR - https://www.researchprotocols.org/2020/6/e16170 UR - http://dx.doi.org/10.2196/16170 UR - http://www.ncbi.nlm.nih.gov/pubmed/32502969 ID - info:doi/10.2196/16170 ER - TY - JOUR AU - Pizzoli, Francesca Silvia Maria AU - Marzorati, Chiara AU - Mazzoni, Davide AU - Pravettoni, Gabriella PY - 2020/6/17 TI - An Internet-Based Intervention to Alleviate Stress During Social Isolation With Guided Relaxation and Meditation: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e19236 VL - 9 IS - 6 KW - relaxation KW - guided meditation KW - internet-based intervention KW - social isolation KW - stress KW - COVID-19 KW - mental health KW - public health N2 - Background: Psychophysiological stress and decreased well-being are relevant issues during prolonged social isolation periods. Relaxation practices may represent helpful exercises to cope with anxiety and stressful sensations. Objective: The aim of this research protocol is to test whether remote relaxation practices such as natural sounds, deep respiration, and body scan meditation promote relaxation and improved emotional state and reduce psychomotor activation and the preoccupation related to the coronavirus disease (COVID-19) pandemic. Methods: The study population will consist of 3 experimental groups that will randomly receive one of 3 internet-based audio clips containing a single session of guided breathing exercise, guided body scan exercise, or natural sounds. The participants will listen to the fully automated audio clip for 7 minutes and complete pre-post self-assessment scales on their perceived relaxation, psychomotor activation, level of worry associated with COVID-19, and emotional state. At the end of the session, the participants will also be asked to provide qualitative reports on their subjective experiences. Results: Analyses will be performed to test the differences in the efficacy of the different audio clips in an internet-based intervention on 252 participants (84 per group), investigating whether natural sounds or remote guided practices such as deep respiration and body scan meditation positively enhance the participants? perceived psychological state. Conclusions: The study will provide information on if and to what extent guided practices can help in reducing psychological side effects related to social isolation during the COVID-19 pandemic. International Registered Report Identifier (IRRID): PRR1-10.2196/19236 UR - http://www.researchprotocols.org/2020/6/e19236/ UR - http://dx.doi.org/10.2196/19236 UR - http://www.ncbi.nlm.nih.gov/pubmed/32530814 ID - info:doi/10.2196/19236 ER - TY - JOUR AU - Tang, K. Hong AU - Nguyen, Ngoc-Minh AU - Dibley, J. Michael AU - Nguyen, D. Trang H. H. AU - Alam, Ashraful PY - 2020/6/26 TI - Improving the Lifestyle of Adolescents Through Peer Education and Support in Vietnam: Protocol for a Pilot Cluster Randomized Controlled Trial JO - JMIR Res Protoc SP - e15930 VL - 9 IS - 6 KW - peer education KW - peer support KW - peer leader KW - adolescents KW - dietary behaviors KW - physical activity KW - Vietnam N2 - Background: In Ho Chi Minh City, Vietnam, recent studies found a rapid increase in overweight and obesity in adolescents. There is a need for effective health promotion interventions to support healthy diets and encourage a physically active lifestyle. This study will help fill an evidence gap on effective interventions to prevent excess weight gain in adolescents and generate new insights about peer-led education to promote healthy lifestyles. Objective: We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City. Additionally, the efficacy of the intervention on adolescents? dietary practices and time spent on physical activity will also be measured in this pilot study. Methods: The Peer Education and Peer Support (PEPS) project is a pilot cluster randomized controlled trial with 2 intervention and 2 control schools. The intervention consists of 4 weekly education sessions of why and how to choose healthy food and drinks and how to be more physically active. Additionally, the intervention includes a school-based and online support system to help maintain student engagement during the intervention. We will use in-depth interviews with students, peer leaders, teachers, and parents; focus group discussions with peer educators; and direct observation of the school environment and peer leaders? interactions with the students. Acceptability and feasibility of the intervention will be assessed. We will also quantitatively assess limited efficacy by measuring changes in student? physical activity levels and dietary behaviors. Results: We delivered the peer education intervention at the start of each school year over 3 months for all new grade 6 adolescents in the selected schools, followed by peer support and home engagement activities over 6 months until the end of the school year. There was a baseline assessment and 2 post-intervention assessments: the first immediately after the intervention to assess the short-term impact and the second at the end of the school year to assess the sustained impact on changes in adiposity, diet, and physical activity. Conclusions: The findings of this study will be used to develop a larger-scale cluster randomized controlled trial to examine the impact of a multicomponent, school- and home-based health promotion intervention. The trial will use innovative peer education methods to reduce overweight and obesity and improve dietary choices and physical activity levels in Vietnamese adolescents. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000421134; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376690&isReview=true International Registered Report Identifier (IRRID): DERR1-10.2196/15930 UR - http://www.researchprotocols.org/2020/6/e15930/ UR - http://dx.doi.org/10.2196/15930 UR - http://www.ncbi.nlm.nih.gov/pubmed/32589155 ID - info:doi/10.2196/15930 ER - TY - JOUR AU - Hasan, Tafsir S. M. AU - Ahmed, Imran Syed AU - Khan, Alfazal Md AU - Sarker, Alam Shafiqul AU - Ahmed, Tahmeed PY - 2020/6/15 TI - Achieving Optimal Gestational Weight Gain, Birth Weight, and Perinatal Outcomes Among Pregnant Women at Risk of Hypertension: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e16676 VL - 9 IS - 6 KW - hypertensive disorder KW - hypertension KW - pregnancy KW - preeclampsia KW - gestational weight gain KW - continuous blood pressure monitor KW - wearable device KW - Health Gauge KW - birth weight KW - perinatal outcome N2 - Background: Hypertensive disorders, including preeclampsia, complicate 10% of all pregnancies, causing maternal and fetal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive disorders. Conventional antenatal care practices often delay or miss detecting hypertensive disorders in pregnancy, which may allow some women to become vulnerable to the adverse consequences of the hypertensive disorders. Regular self-monitoring of blood pressure and weight gain may improve maternal and fetal outcomes among pregnant women at risk of developing hypertensive disorders during pregnancy through early diagnosis, prompt referral, and timely clinical management; however, to undertake a randomized controlled trial of an intervention to reduce adverse consequences of hypertensive disorders in pregnancy, its feasibility must first be determined. Objective: The objectives of this study are to evaluate the accuracy of a wearable blood pressure monitoring device (Health Gauge) in order to test the design and methods of a future definitive randomized controlled trial, and to examine the feasibility, acceptability, and fidelity of an intervention focusing on regular monitoring of weight gain and self-monitoring of blood pressure for pregnant women at risk of developing hypertensive disorders and their associated complications. Methods: The study is located in Matlab, Bangladesh will be conducted in two phases. First, a wearable blood pressure device (Health Gauge) will be validated in accordance with the European Society of Hypertension International Protocol (revision 2010). Second, a prospective, two-arm, parallel, and nonblinded randomized controlled external pilot trial will be conducted. In the pilot trial, 70 eligible participants will be individually randomized to the intervention arm, in which pregnant women will self-monitor their blood pressure daily using a wearable device (Health Gauge) and be evaluated monthly by trained health workers for weight gain from 20 weeks of gestation until delivery, or the control arm, in which pregnant women will be assessed for weight gain every two months from 20 weeks of gestation until delivery (1:1 intervention to control allocation ratio using a permuted block randomization method with concealment). All women will receive standard antenatal care. Results: A validation study of the wearable blood pressure device has successfully been conducted among the general adult population in Matlab, Bangladesh. As of September 2019, the pilot trial has completed enrollment of women who are pregnant (N=70; intervention: n=35; control: n=35) and follow-up of the participants is ongoing. Data analysis is expected to be completed by June 2020, and results are expected to be submitted for publication in August 2020. Conclusions: The findings of this study will help us to design a comprehensive, full-scale randomized controlled trial to test the efficacy of regular self-monitoring of blood pressure and weight gain during pregnancy, a simple and inexpensive intervention to help to achieve optimal maternal and fetal outcomes in pregnant women at risk of developing hypertensive disorders and their associated complications during pregnancy. Trial Registration: ClinicalTrials.gov NCT03858595; https://clinicaltrials.gov/ct2/show/NCT03858595 International Registered Report Identifier (IRRID): DERR1-10.2196/16676 UR - http://www.researchprotocols.org/2020/6/e16676/ UR - http://dx.doi.org/10.2196/16676 UR - http://www.ncbi.nlm.nih.gov/pubmed/32459639 ID - info:doi/10.2196/16676 ER - TY - JOUR AU - Bodnar, M. Lisa AU - Khodyakov, Dmitry AU - Himes, P. Katherine AU - Burke, G. Jessica AU - Parisi, Sara AU - Hutcheon, A. Jennifer PY - 2020/6/2 TI - Engaging Patients and Professionals to Evaluate the Seriousness of Maternal and Child Health Outcomes: Protocol for a Modified Delphi Study JO - JMIR Res Protoc SP - e16478 VL - 9 IS - 6 KW - children KW - Delphi method KW - ExpertLens KW - mothers KW - pregnancy KW - patient engagement KW - online stakeholder engagement panels N2 - Background: Maternal weight gain during pregnancy is one of the few potentially modifiable risk factors for many adverse maternal and child health outcomes. Defining the optimal pregnancy weight gain range is difficult because, while lower weight gain may prevent some outcomes, such as maternal and child obesity, it may increase the risk of others such as fetal growth restriction and infant death. These health outcomes vary in their seriousness to mothers and their health care providers, and these differences in seriousness should be taken into account when determining optimal weight gain ranges. However, the relative seriousness that women and their care providers place on different health outcomes is unknown. Objective: We will determine the seriousness of 11 maternal and child health outcomes that have been consistently associated with pregnancy weight gain. We will achieve this by engaging patients and maternal and child health professionals using an online modified Delphi panel process. Methods: We aim to recruit a racially/ethnically and geographically diverse group of 90 US maternal and child health professionals and 90 women who are pregnant or less than 2 years postpartum. We will conduct 3 concurrent panels using the ExpertLens system, a previously evaluated online modified Delphi system that combines 2 rounds of rating with 1 round of feedback and moderated online discussion. In Round 1, panelists are asked to rate the seriousness of each health outcome on a scale of 0-100 and to provide a rationale for their scores. In Round 2, panelists will review their responses relative to those of other panelists. They will discuss their seriousness ratings anonymously using a moderated online discussion board. In Round 3, participants will revise their Round 1 responses based on group feedback and discussion. Each round will be open for 1-2 weeks. Results: The study protocol was reviewed by our ethics boards and did not require approval as human research. A pilot study of 6 professionals and 7 patients was completed in December 2019. Conclusions: Our numeric estimates of the seriousness of maternal and child health outcomes will enable future studies to determine pregnancy weight gain ranges that balance the risks of low and high weight gain for mothers and children. International Registered Report Identifier (IRRID): DERR1-10.2196/16478 UR - https://www.researchprotocols.org/2020/6/e16478 UR - http://dx.doi.org/10.2196/16478 UR - http://www.ncbi.nlm.nih.gov/pubmed/32222699 ID - info:doi/10.2196/16478 ER - TY - JOUR AU - Singh, Arti AU - Nichols, Michelle PY - 2020/6/3 TI - Nurse-Led Education and Engagement for Diabetes Care in Sub-Saharan Africa: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e15408 VL - 9 IS - 6 KW - diabetes KW - mobile health KW - Ghana KW - sub-Saharan Africa KW - global health KW - nurses KW - task-shifting KW - mixed methods KW - focused ethnography N2 - Background: As the impact of diabetes grows steeply in sub-Saharan Africa, improvement of the control and treatment of diabetes is a goal that health care systems in sub-Saharan Africa must achieve in the near future. Sub-Saharan Africa faces a number of challenges in addressing the increasing effects of diabetes. One important factor is the shortage of adequately trained health care workers. Diabetes management in sub-Saharan Africa would benefit from innovative approaches that are founded upon solid theoretical constructs, built upon existing human resources and infrastructure, and culturally tailored to the priorities and needs of the local population. Existing resources, such as mobile phones and task-shifting strategies, may be used to assist individuals with glycemic self-management and to facilitate management of additional day-to-day clinical responsibilities. Objective: The objective of the Nurse-Led Education and Engagement Study for Diabetes Care (NEEDS) mixed-methods protocol is to develop a practical, collaborative, effective, and sustainable program for diabetes prevention and management specifically for patients with type 2 diabetes mellitus in sub-Saharan Africa. The protocol aims to improve access to care through task-shifting strategies and the use of mobile health technology. Methods: This study was designed using a convergent parallel mixed-methods approach that consisted of surveys, key informant interviews, focus group discussions, and focused ethnography. Novel approaches, such as task-shifting strategies and the use of mobile technology, were implemented for type 2 diabetes mellitus health care in sub-Saharan Africa?currently an under-researched area. Results: Data collection began in February 2018, after ethics approval, at the Kwame Nkrumah University of Science and Technology. As of May 2020, participant surveys have been completed (N=100), key informant interviews (n=7) have been completed, and focus groups (5 focus groups; patients, n=18; caregivers, n=6; community leaders, n=2; and faith leaders, n=3) as well as focused ethnographic field observations have been completed. All audio recordings have been transcribed and transcripts of sessions recorded in Twi have been translated to English. Data analysis is currently underway and anticipated completion is in the spring of 2020. Following data analysis, investigators plan to publish study findings. Conclusions: Insights from this study will inform the preliminary development of a feasible and effective nurse-led education and engagement mobile health intervention that has the potential to reduce diabetes-related morbidity, mortality, and burden in sub-Saharan Africa. International Registered Report Identifier (IRRID): DERR1-10.2196/15408 UR - https://www.researchprotocols.org/2020/6/e15408 UR - http://dx.doi.org/10.2196/15408 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442137 ID - info:doi/10.2196/15408 ER - TY - JOUR AU - Agyapong, Opoku Vincent Israel AU - Hrabok, Marianne AU - Vuong, Wesley AU - Gusnowski, April AU - Shalaby, Reham AU - Mrklas, Kelly AU - Li, Daniel AU - Urichuk, Liana AU - Snaterse, Mark AU - Surood, Shireen AU - Cao, Bo AU - Li, Xin-Min AU - Greiner, Russ AU - Greenshaw, James Andrew PY - 2020/6/22 TI - Closing the Psychological Treatment Gap During the COVID-19 Pandemic With a Supportive Text Messaging Program: Protocol for Implementation and Evaluation JO - JMIR Res Protoc SP - e19292 VL - 9 IS - 6 KW - COVID-19 KW - Text4Hope KW - mobile phones KW - text KW - anxiety KW - depression KW - stress KW - pandemic KW - e-mental health N2 - Background: Coronavirus disease (COVID-19) has spread globally with far-reaching, significant, and unprecedented impacts on health and everyday life. Threats to mental health, psychological safety, and well-being are now emerging, increasing the impact of this virus on world health. Providing support for these challenges is difficult because of the high number of people requiring support in the context of a need to maintain physical distancing. This protocol describes the use of SMS text messaging (Text4Hope) as a convenient, cost-effective, and accessible population-level mental health intervention. This program is evidence-based, with prior research supporting good outcomes and high user satisfaction. Objective: The project goal is to implement a program of daily supportive SMS text messaging (Text4Hope) to reduce distress related to the COVID-19 crisis, initially among Canadians. The prevalence of stress, anxiety, and depressive symptoms; the demographic correlates of the same; and the outcomes of the Text4Hope intervention in mitigating distress will be evaluated. Methods: Self-administered anonymous online questionnaires will be used to assess stress (Perceived Stress Scale), anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]), and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]). Data will be collected at baseline (onset of SMS text messaging), the program midpoint (6 weeks), and the program endpoint (12 weeks). Results: Data analysis will include parametric and nonparametric techniques, focusing on primary outcomes (ie, stress, anxiety, and depressive symptoms) and metrics of use, including the number of subscribers and user satisfaction. Given the large size of the data set, machine learning and data mining methods will also be used. Conclusions: This COVID-19 project will provide key information regarding prevalence rates of stress, anxiety, and depressive symptoms during the pandemic; demographic correlates of distress; and outcome data related to this scalable population-level intervention. Information from this study will be valuable for practitioners and useful for informing policy and decision making regarding psychological interventions during the pandemic. International Registered Report Identifier (IRRID): DERR1-10.2196/19292 UR - http://www.researchprotocols.org/2020/6/e19292/ UR - http://dx.doi.org/10.2196/19292 UR - http://www.ncbi.nlm.nih.gov/pubmed/32501805 ID - info:doi/10.2196/19292 ER - TY - JOUR AU - van der Vliet, Nina AU - Den Broeder, Lea AU - Romeo-Velilla, María AU - Kruize, Hanneke AU - Staatsen, Brigit AU - Schuit, Jantine PY - 2020/6/24 TI - Intersectoral Cooperation in 12 European Case Studies Aiming for Better Health, Environmental Sustainability, and Health Equity: Protocol for a Qualitative Evaluation JO - JMIR Res Protoc SP - e17323 VL - 9 IS - 6 KW - intersectoral cooperation KW - health KW - environmental sustainability KW - equity KW - focus groups KW - protocol N2 - Background: The INHERIT (INtersectoral Health and Environment Research for InnovaTion) project has evaluated intersectoral cooperation (IC) in 12 European case studies attempting to promote health, environmental sustainability, and equity through behavior and lifestyle changes. These factors are the concerns of multiple sectors of government and society. Cooperation of health and environmental sectors with other sectors is needed to enable effective action. IC is thus essential to promote a triple win of health, sustainability, and equity. Objective: This paper describes the design of a qualitative study to gain insights into successful organization of IC, facilitators and barriers, and how future steps can be taken to improve IC in the evaluated case studies. Methods: Each case study was assessed qualitatively through a focus group. A total of 12 focus groups in 10 different European countries with stakeholders, implementers, policymakers, and/or citizens were held between October 2018 and March 2019. Five to eight participants attended each focus group. The focus group method was based on appreciative inquiry, which is an asset-based approach focusing on what works well, why it is working well, and how to strengthen assets in the future. A stepped approach was used, with central coordination and analysis, and local implementation and reporting. Local teams were trained to apply a common protocol using a webinar and handbook on organizing, conducting, and reporting focus groups. Data were gathered in each country in the local language. Translated data were analyzed centrally using deductive thematic analysis, with consideration of further emerging themes. Analyses involved the capability, opportunity, motivation-behavior (COM-b) system to categorize facilitators and barriers into capability, motivation, or opportunity-related themes, as these factors influence the behaviors of individuals and groups. Web-based review sessions with representatives from all local research teams were held to check data analysis results and evaluate the stepped approach. Results: Data collection has been completed. A total of 76 individuals participated in 12 focus groups. In December 2019, data analysis was nearly complete, and the results are expected to be published in fall 2020. Conclusions: This study proposes a stepped approach that allows cross-country focus group research using a strict protocol while dealing with language and cultural differences. The study generates insights into IC processes and facilitators in different countries and case studies to filter out which facilitators are essential to include. Simultaneously, the approach can strengthen cooperation among stakeholders by looking at future cooperation possibilities. By providing knowledge on how to plan for, improve, and sustain IC successfully to deal with today?s multisectoral challenges, this study can contribute to better intersectoral action for the triple win of better health, sustainability, and equity. This protocol can serve as a tool for other researchers who plan to conduct cross-country qualitative research. International Registered Report Identifier (IRRID): RR1-10.2196/17323 UR - http://www.researchprotocols.org/2020/6/e17323/ UR - http://dx.doi.org/10.2196/17323 UR - http://www.ncbi.nlm.nih.gov/pubmed/32579122 ID - info:doi/10.2196/17323 ER - TY - JOUR AU - Gagnon, Marianne AU - Collins, Jessica AU - Elfassy, Caroline AU - Marino Merlo, Gabriela AU - Marsh, Jacquelyn AU - Sawatzky, Bonita AU - Yap, Rita AU - Hamdy, Reggie AU - Veilleux, Louis-Nicolas AU - Dahan-Oliel, Noémi PY - 2020/6/26 TI - A Telerehabilitation Intervention for Youths With Arthrogryposis Multiplex Congenita: Protocol for a Pilot Study JO - JMIR Res Protoc SP - e18688 VL - 9 IS - 6 KW - telerehabilitation KW - arthrogryposis multiplex congenita KW - physical therapy KW - occupational therapy N2 - Background: Arthrogryposis multiplex congenita (AMC) is characterized by joint contractures present in at least two body areas. In addition to these contractures, individuals with AMC can have decreased muscle mass, leading to limitations in activities of daily living. Exercise has the potential to maintain or improve the range of motion and muscle strength. However, this type of intervention necessitates frequent follow ups that are currently difficult to provide for youths with AMC because they often live far from a specialized hospital. To overcome this distance challenge, telecommunication technologies can be used to deliver rehabilitation remotely, which is called telerehabilitation. The study protocol for one such type of rehabilitation will be presented in this paper. Objective: This pilot study aims to (1) evaluate the feasibility of using telerehabilitation to provide a home exercise program for youths with AMC, and (2) assess the effectiveness of a home exercise program. Methods: A total of 10 youths aged 8-21 years with AMC will be recruited. The intervention consists of a 12-week individualized home-based exercise program delivered remotely using telerehabilitation. At baseline, youths will complete the Physical Activity Questionnaire for Adolescents and the Pediatrics Outcomes Data Collection Instrument to assess pain, function, and level of physical activity. During the first telerehabilitation meeting, the rehabilitation therapists will measure range of motion using a virtual goniometer and assess the youth?s functional level. The therapists will then use the Goal Attainment Scale to set objectives and develop the individualized intervention. Follow ups will occur every 3 weeks to make sure exercises are performed safely and to progress the exercises when needed. At the end of the 12-week intervention, rehabilitation therapists will re-evaluate the youth using the same outcome measures as the initial evaluation. The youths will be asked to complete the same questionnaires, with the addition of questions about their satisfaction regarding the intervention. Nonparametric and descriptive statistics will be used to evaluate the feasibility and effectiveness. Results: Ethics approval was obtained in October 2018. Recruitment and data collection started in January 2019 and was completed in May 2020. Conclusions: This pilot study will help us learn how a large-scale project may work in practice to improve outcomes in physical activity, pain, and function, and goal attainment among youths with AMC, thus informing a future clinical trial. International Registered Report Identifier (IRRID): DERR1-10.2196/18688 UR - http://www.researchprotocols.org/2020/6/e18688/ UR - http://dx.doi.org/10.2196/18688 UR - http://www.ncbi.nlm.nih.gov/pubmed/32589157 ID - info:doi/10.2196/18688 ER - TY - JOUR AU - Chinna Meyyappan, Arthi AU - Milev, Roumen PY - 2020/6/4 TI - The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder: Protocol for a Phase 1, Open-Label Study JO - JMIR Res Protoc SP - e17223 VL - 9 IS - 6 KW - depression KW - anxiety KW - microbial ecosystem therapy KW - gut-brain axis KW - microbiome KW - clinical trial KW - protocol N2 - Background: The bidirectional signaling between the gut microbiota and the brain, known as the gut-brain axis, is being heavily explored in current neuropsychiatric research. Analyses of the human gut microbiota have shown considerable individual variability in bacterial content, which is hypothesized to influence brain function, and potentially mood and anxiety symptoms, through gut-brain axis communication. Preclinical and clinical research examining these effects suggests that fecal microbiota transplant (FMT) may aid in improving the severity of depression and anxiety symptoms by recolonizing the gastrointestinal (GI) tract with healthy bacteria. The microbial ecosystem therapeutic (ie, microbial ecosystem therapeutic-2 [MET-2]) used in this study is an alternative treatment to FMT, which comprises 40 different strains of gut bacteria from a healthy donor. Objective: The primary objective of this study is to assess subjective changes in mood and anxiety symptoms before, during, and after administration of MET-2. The secondary objectives of this study are to assess the changes in metabolic functioning and the level of repopulation of healthy gut bacteria, the safety and tolerability of MET-2, and the effects of early stress on biomarkers of depression/anxiety and the response to treatment. Methods: Adults experiencing depressive or anxiety symptoms will be recruited from the Kingston area. These participants will orally consume an encapsulated MET-2 once daily?containing 40 strains of purified and laboratory-grown bacteria from a single healthy donor?for 8 weeks, followed by a 2-week treatment-free follow-up period. Participants will undergo a series of clinical assessments measuring mood, anxiety, and GI symptoms using validated clinical scales and questionnaires. Molecular data will be collected from blood and fecal samples to assess metabolic changes, neurotransmitter levels, inflammatory markers, and the level of engraftment of the fecal samples that may predict outcomes in depression or anxiety. Results: Given the association between the gut bacteria and the risk factors of depression, we expect to observe an improvement in the severity of depressive and anxiety symptoms following treatment, and we expect that this improvement is mediated by the recolonization of the GI tract with healthy bacteria. The recruitment for this study has been completed, and the data obtained are currently being analyzed. Conclusions: This is the first time MET-2 is being tested in psychiatric indications, specifically depression and anxiety. As such, this may be the first study to show the potential effects of microbial therapy in alleviating psychiatric symptoms as well as its safety and tolerability. International Registered Report Identifier (IRRID): DERR1-10.2196/17223 UR - https://www.researchprotocols.org/2020/6/e17223 UR - http://dx.doi.org/10.2196/17223 UR - http://www.ncbi.nlm.nih.gov/pubmed/32495743 ID - info:doi/10.2196/17223 ER - TY - JOUR AU - Schindera, Christina AU - Kuehni, Elisabeth Claudia AU - Pavlovic, Mladen AU - Haegler-Laube, Simona Eva AU - Rhyner, Daniel AU - Waespe, Nicolas AU - Roessler, Jochen AU - Suter, Thomas AU - von der Weid, Xavier Nicolas PY - 2020/6/10 TI - Diagnosing Preclinical Cardiac Dysfunction in Swiss Childhood Cancer Survivors: Protocol for a Single-Center Cohort Study JO - JMIR Res Protoc SP - e17724 VL - 9 IS - 6 KW - cardiotoxicity KW - Switzerland KW - echocardiography KW - speckle tracking KW - strain KW - anthracyclines KW - alkylating agents KW - steroids KW - cardiac radiation N2 - Background: Cardiovascular disease is the leading nonmalignant cause of late deaths in childhood cancer survivors. Cardiovascular disease and cardiac dysfunction can remain asymptomatic for many years, but eventually lead to progressive disease with high morbidity and mortality. Early detection and intervention are therefore crucial to improve outcomes. Objective: In our study, we aim to assess the prevalence of preclinical cardiac dysfunction in adult childhood cancer survivors using conventional and speckle tracking echocardiography; determine the association between cardiac dysfunction and treatment-related risk factors (anthracyclines, alkylating agents, steroids, cardiac radiation) and modifiable cardiovascular risk factors (abdominal obesity, hypertension); investigate the development of cardiac dysfunction longitudinally in a defined cohort; study the association between cardiac dysfunction and other health outcomes like pulmonary disease, endocrine disease, renal disease, quality of life, fatigue, strength and endurance, and physical activity; and gain experience conducting a clinical study of childhood cancer survivors that will be extended to a national, multicenter study of cardiac complications. Methods: For this retrospective cohort study, we will invite ?5-year childhood cancer survivors who were treated at the University Children's Hospital Bern, Switzerland with any chemotherapy or cardiac radiation since 1976 and who are ?18 years of age at the time of the study for a cardiac assessment at the University Hospital Bern. This includes 544 childhood cancer survivors, of whom about half were treated with anthracyclines and/or cardiac radiation and half with any other chemotherapy. The standardized cardiac assessment includes a medical history focusing on signs of cardiovascular disease and its risk factors, a physical examination, anthropometry, vital parameters, the 1-minute sit-to-stand test, and echocardiography including 2-dimensional speckle tracking. Results: We will invite 544 eligible childhood cancer survivors (median age at the time of the study, 32.5 years; median length of time since diagnosis, 25.0 years) for a cardiac assessment. Of these survivors, 300 (55%) are at high risk, and 244 (45%) are at standard risk of cardiac dysfunction. Conclusions: This study will determine the prevalence of preclinical cardiac dysfunction in Swiss childhood cancer survivors, inform whether speckle tracking echocardiography is more sensitive to cardiac dysfunction than conventional echocardiography, and give a detailed picture of risk factors for cardiac dysfunction. The results will help improve primary treatment and follow-up care of children with cancer. Trial Registration: ClinicalTrials.gov NCT03790943; https://clinicaltrials.gov/ct2/show/NCT03790943 International Registered Report Identifier (IRRID): DERR1-10.2196/17724 UR - http://www.researchprotocols.org/2020/6/e17724/ UR - http://dx.doi.org/10.2196/17724 UR - http://www.ncbi.nlm.nih.gov/pubmed/32269016 ID - info:doi/10.2196/17724 ER - TY - JOUR AU - Hannerz, Harald AU - Albertsen, Karen AU - Nielsen, Lindhardt Martin AU - Garde, Helene Anne PY - 2020/6/15 TI - Prospective Associations Between Working Time Arrangements and Psychiatric Treatment in Denmark: Protocol for a Cohort Study JO - JMIR Res Protoc SP - e18236 VL - 9 IS - 6 KW - occupational health KW - long working hours KW - night shift work KW - mood disorders KW - anxiety KW - stress-related disorders KW - psychiatric hospital treatment KW - prescription drugs KW - psychotropic medicine N2 - Background: The burden of mental ill health in working-age populations has prompted research on possible links between work-related factors and mental ill health. Long working hours and night shift work are some of the factors that have been studied in relation to the risk of developing mental ill health. Yet, previous studies have not generated conclusive evidence, and further studies of high quality are needed. Objective: This study aims to investigate the prospective association between working time arrangements and mental health in terms of psychotropic drug usage or psychiatric hospital treatment in the general working population of Denmark. Methods: Data on total weekly working hours in any job and night shift work from the Danish Labor Force Survey 2000?2013 will be linked to data from the Psychiatric Central Research Register (expected 2400 cases during 700,000 person years at risk) and National Prescription Registry (expected 17,400 cases during 600,000 person years at risk). Participants will be followed for up to 5 years. We will use Poisson regression to separately analyze incidence rates of redeemed prescriptions for psychotropic medicine and incidence rates of psychiatric hospital treatment due to mood disorders, anxiety disorders, or stress-related disorders as a function of weekly working hours and night shift work. The analyses will be controlled for sex, age, calendar time of the interview, and socioeconomic status. Results: This is a study protocol. Power calculations indicate that the study has sufficient statistical power to detect relatively small differences in risks and minor interactions (eg, ~90% power to detect a rate ratio of 1.1 for psychoactive medication use). We expect the analyses to be completed by the end of 2020 and the results to be published in 2021. Conclusions: In this study protocol, all hypotheses and statistical models of the project have been completely defined before we link the exposure data to the outcome data. The results of the project will indicate to what extent and in what direction the national burden of mental ill health in Denmark has been influenced by long working hours and night shift work. International Registered Report Identifier (IRRID): DERR1-10.2196/18236 UR - https://www.researchprotocols.org/2020/6/e18236 UR - http://dx.doi.org/10.2196/18236 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442158 ID - info:doi/10.2196/18236 ER - TY - JOUR AU - Smith, Alexander AU - Bains, Natalie AU - Copeland, Lauren AU - Pennington, Anna AU - Carter, Ben AU - Hewitt, Jonathan PY - 2020/6/17 TI - Morbidity Prevalence Estimate at 6 Months Following a Stroke: Protocol for a Cohort Study JO - JMIR Res Protoc SP - e15851 VL - 9 IS - 6 KW - stroke KW - prevalence estimate KW - morbidity KW - disability KW - PROMs KW - outcomes KW - quality of life (QoL) N2 - Background: Knowledge of the prevalence of morbidity secondary to stroke is important for health care professionals, health care commissioners, third sector organizations, and stroke survivors to understand the likely progress of poststroke sequelae and to aid in commissioning decisions, planning care, and adjusting to life after stroke. Objective: The primary aim of the Morbidity PRevalence Estimate In StrokE (MORe PREcISE) study is to determine the prevalence of morbidity secondary to a stroke, predictors of morbidity, and trends in quality of life and functional status using patient-reported outcomes, cognitive and functional assessments. Methods: A total of 500 participants will be recruited across Wales and England within 14 days following an admission to a stroke unit for either an ischemic or hemorrhagic stroke as part of a multicenter cohort study. Participants are assessed at baseline ?14 days poststroke and subsequently at 90 (± 14) days and 180 (± 14) days poststroke. At each time point, data will be collected relating to the following domains: participant demographics, routine clinical, patient reported, cognitive status, emotional well-being, and functional ability. Results: Recruitment commenced in October 2018 with 20 sites opened as of September 2019 and was closed on October 31, 2019. Conclusions: The primary outcome is the prevalence of morbidity at 6 months secondary to a stroke. Further analysis will consider temporal changes in the health-related domains to describe trends among baseline, 3-, and 6-month time points. Trial Registration: ClinicalTrials.gov NCT03605381; https://clinicaltrials.gov/ct2/show/NCT03605381 International Registered Report Identifier (IRRID): DERR1-10.2196/15851 UR - https://www.researchprotocols.org/2020/6/e15851 UR - http://dx.doi.org/10.2196/15851 UR - http://www.ncbi.nlm.nih.gov/pubmed/32512539 ID - info:doi/10.2196/15851 ER - TY - JOUR AU - Kotsopoulos, M. Angela M. AU - Vos, Piet AU - Jansen, E. Nichon AU - Bronkhorst, M. Ewald AU - van der Hoeven, G. Johannes AU - Abdo, F. Wilson PY - 2020/6/23 TI - Prediction Model for Timing of Death in Potential Donors After Circulatory Death (DCD III): Protocol for a Multicenter Prospective Observational Cohort Study JO - JMIR Res Protoc SP - e16733 VL - 9 IS - 6 KW - organ donation KW - tissue and organ procurement KW - clinical prediction rule KW - donation after circulatory death KW - clinical protocols KW - withdrawal of life-sustaining treatment KW - end-of-life care KW - organ transplant KW - circulatory death KW - cohort study KW - intensive care unit KW - organ donor N2 - Background: Controlled donation after circulatory death (cDCD) is a major source of organs for transplantation. A potential cDCD donor poses considerable challenges in terms of identification of those dying within the predefined time frame of warm ischemia after withdrawal of life-sustaining treatment (WLST) to circulatory arrest. Several attempts have been made to develop models predicting the time between treatment withdrawal and circulatory arrest. This time window determines whether organ donation can occur and influences the quality of the donated organs. However, the selected patients used for these models were not always restricted to potential cDCD donors (eg, patients with cancer or severe infections were also included). This severely limits the generalizability of those data. Objective: The objectives of this study are the following: (1) to develop a model predicting time to death within 60 minutes in potential cDCD patients; (2) to validate and update previous prediction models on time to death after WLST; (3) to determine timing and patient characteristics that are associated with prognostication and the decision-making process that leads to initiating end-of-life care; (4) to evaluate the impact of timing of family approach on organ donation approval; and (5) to assess the influence of variation in WLST processes on postmortem organ donor potential and actual postmortem organ donors. Methods: In this multicenter observational prospective cohort study, all patients admitted to the intensive care unit of 3 university hospitals and 3 teaching hospitals who met the criteria of the cDCD protocol as defined by the Dutch Transplant Foundation were included. The target of enrolment was set to 400 patients. Previously developed models will be refitted in our data set. To further update previous prediction models, we will apply least absolute shrinkage and selection operator (LASSO) as a tool for efficient variable selection to develop the multivariable logistic regression model. Results: This protocol was funded in August 2014 by the Dutch Transplant Foundation. We expect to have the results of this study in July 2020. Patient enrolment was completed in July 2018 and data collection was completed in April 2020. Conclusions: This study will provide a robust multimodal prediction model, based on clinical and physiological parameters, that can predict time to circulatory arrest in cDCD donors. In addition, it will add valuable insight in the process of WLST in cDCD donors and will fill an important knowledge gap in this essential field of health care. Trial Registration: ClinicalTrials.gov NCT04123275; https://clinicaltrials.gov/ct2/show/NCT04123275 International Registered Report Identifier (IRRID): DERR1-10.2196/16733 UR - http://www.researchprotocols.org/2020/6/e16733/ UR - http://dx.doi.org/10.2196/16733 UR - http://www.ncbi.nlm.nih.gov/pubmed/32459638 ID - info:doi/10.2196/16733 ER - TY - JOUR AU - Chandanabhumma, Paul P. AU - Fetters, D. Michael AU - Pagani, D. Francis AU - Malani, N. Preeti AU - Hollingsworth, M. John AU - Funk, J. Russell AU - Aaronson, D. Keith AU - Zhang, Min AU - Kormos, L. Robert AU - Chenoweth, E. Carol AU - Shore, Supriya AU - Watt, F. Tessa M. AU - Cabrera, Lourdes AU - Likosky, S. Donald PY - 2020/6/11 TI - Authorship Correction: Understanding and Addressing Variation in Health Care?Associated Infections After Durable Ventricular Assist Device Therapy: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e18324 VL - 9 IS - 6 UR - https://www.researchprotocols.org/2020/6/e18324 UR - http://dx.doi.org/10.2196/18324 UR - http://www.ncbi.nlm.nih.gov/pubmed/32525812 ID - info:doi/10.2196/18324 ER - TY - JOUR AU - Lal, Shalini AU - Starcevic, Joanna Danielle AU - Fuhrer, Rebecca PY - 2020/6/12 TI - Correction: Youth Experiences With Referrals to Mental Health Services in Canada: Protocol for a Web-Based Cross-Sectional Survey Study JO - JMIR Res Protoc SP - e19019 VL - 9 IS - 6 UR - https://www.researchprotocols.org/2020/6/e19019 UR - http://dx.doi.org/10.2196/19019 UR - http://www.ncbi.nlm.nih.gov/pubmed/32530818 ID - info:doi/10.2196/19019 ER - TY - JOUR AU - Silingardi, Roberto AU - Sirignano, Pasqualino AU - Andreoli, Francesco AU - Mansour, Wassim AU - Migliari, Mattia AU - Speziale, Francesco AU - PY - 2020/6/24 TI - Correction: Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study JO - JMIR Res Protoc SP - e20698 VL - 9 IS - 6 UR - http://www.researchprotocols.org/2020/6/e20698/ UR - http://dx.doi.org/10.2196/20698 UR - http://www.ncbi.nlm.nih.gov/pubmed/32579539 ID - info:doi/10.2196/20698 ER - TY - JOUR AU - Khan, Zaman Danyal AU - Khan, Shuaib Muhammad AU - Kotter, RN Mark AU - Davies, Marshall Benjamin PY - 2020/6/11 TI - Tackling Research Inefficiency in Degenerative Cervical Myelopathy: Illustrative Review JO - JMIR Res Protoc SP - e15922 VL - 9 IS - 6 KW - cervical KW - myelopathy KW - spondylosis KW - spondylotic KW - stenosis KW - disc herniation KW - ossification posterior longitudinal ligament KW - systematic review KW - research inefficiency KW - imprecision N2 - Background: Degenerative cervical myelopathy (DCM) is widely accepted as the most common cause of adult myelopathy worldwide. Despite this, there is no specific term or diagnostic criteria in the International Classification of Diseases 11th Revision and no Medical Subject Headings (MeSH) or an equivalent in common literature databases. This makes searching the literature and thus conducting systematic reviews or meta-analyses imprecise and inefficient. Efficient research synthesis is integral to delivering evidence-based medicine and improving research efficiency. Objective: This study aimed to illustrate the difficulties encountered when attempting to carry out a comprehensive and accurate evidence search in the field of DCM by identifying the key sources of imprecision and quantifying their impact. Methods: To identify the key sources of imprecision and quantify their impact, an illustrative search strategy was developed using a validated DCM hedge combined with contemporary strategies used by authors in previous systematic reviews and meta-analyses. This strategy was applied to Medical Literature Analysis and Retrieval System Online (MEDLINE) and Excerpta Medica dataBASE (EMBASE) databases looking for relevant DCM systematic reviews and meta-analyses published within the last 5 years. Results: The MEDLINE via PubMed search strategy returned 24,166 results, refined to 534 papers after the application of inclusion and exclusion criteria. Of these, 32.96% (176/534) results were about DCM, and 18.16% (97/534) of these were DCM systematic reviews or meta-analyses. Non-DCM results were organized into imprecision categories (spinal: 268/534, 50.2%; nonspinal: 84/534, 15.5%; and nonhuman: 8/534, 1.5%). The largest categories were spinal cord injury (75/534, 13.67%), spinal neoplasms (44/534, 8.24%), infectious diseases of the spine and central nervous system (18/534, 3.37%), and other spinal levels (ie, thoracic, lumbar, and sacral; 18/534, 3.37%). Counterintuitively, the use of human and adult PubMed filters was found to exclude a large number of relevant articles. Searching a second database (EMBASE) added an extra 12 DCM systematic reviews or meta-analyses. Conclusions: DCM search strategies face significant imprecision, principally because of overlapping and heterogenous search terms, and inaccurate article indexing. Notably, commonly employed MEDLINE filters, human and adult, reduced search sensitivity, whereas the related articles function and the use of a second database (EMBASE) improved it. Development of a MeSH labeling and a standardized DCM definition would allow comprehensive and specific indexing of DCM literature. This is required to support a more efficient research synthesis. UR - https://www.researchprotocols.org/2020/6/e15922 UR - http://dx.doi.org/10.2196/15922 UR - http://www.ncbi.nlm.nih.gov/pubmed/32525490 ID - info:doi/10.2196/15922 ER - TY - JOUR AU - Ferrari, Manuela AU - McIlwaine, V. Sarah AU - Reynolds, Ann Jennifer AU - Archie, Suzanne AU - Boydell, Katherine AU - Lal, Shalini AU - Shah, L. Jai AU - Henderson, Joanna AU - Alvarez-Jimenez, Mario AU - Andersson, Neil AU - Boruff, Jill AU - Nielsen, Lundedal Rune Kristian AU - Iyer, N. Srividya PY - 2020/6/24 TI - Digital Game Interventions for Youth Mental Health Services (Gaming My Way to Recovery): Protocol for a Scoping Review JO - JMIR Res Protoc SP - e13834 VL - 9 IS - 6 KW - mental health KW - mental disorders KW - biomedical technology KW - video games KW - virtual reality KW - mental health services N2 - Background: Digital or video games are played by millions of adolescents and young adults around the world and are one of the technologies used by youths to access mental health services. Youths with mental health problems strongly endorse the use of technologies, including mobile and online platforms, to receive information, support their treatment journeys (eg, decision-making tools), and facilitate recovery. A growing body of literature explores the advantages of playing digital games for improving attention span and memory, managing emotions, promoting behavior change, and supporting treatment for mental illness (eg, anxiety, depression, or posttraumatic stress disorder). The research field has also focused on the negative impact of video games, describing potential harms related to aggression, addiction, and depression. To promote clarity on this matter, there is a great need for knowledge synthesis offering recommendations on how video games can be safely and effectively adopted and integrated into youth mental health services. Objective: The Gaming My Way to Recovery scoping review project assesses existing evidence on the use of digital game interventions within the context of mental health services for youths (aged 11-29 years) using the stepped care model as the conceptual framework. The research question is as follows: For which youth mental health conditions have digital games been used and what broad objectives (eg, prevention, treatment) have they addressed? Methods: Using the methodology proposed by Arksey and O?Malley, this scoping review will map the available evidence on the use of digital games for youths between 11 and 29 years old with mental health or substance use problems, or both. Results: The review will bring together evidence-based knowledge to assist mental health providers and policymakers in evaluating the potential benefits and risks of these interventions. Following funding of the project in September 2018, we completed the search in November 2018, and carried out data screening and stakeholder engagement activities during preparation of the protocol. We will conduct a knowledge synthesis based on specific disorders, treatment level and modality, type of service, population, settings, ethical practices, and user engagement and offer recommendations concerning the integration of video game technologies and programs, future research and practice, and knowledge dissemination. Conclusions: Digital game interventions employ unique, experiential, and interactive features that potentially improve skills and facilitate learning among players. Digital games may also provide a new treatment platform for youths with mental health conditions. Assessing current knowledge on video game technology and interventions may potentially improve the range of interventions offered by youth mental health services while supporting prevention, intervention, and treatment. International Registered Report Identifier (IRRID): PRR1-10.2196/13834 UR - http://www.researchprotocols.org/2020/6/e13834/ UR - http://dx.doi.org/10.2196/13834 UR - http://www.ncbi.nlm.nih.gov/pubmed/32579117 ID - info:doi/10.2196/13834 ER - TY - JOUR AU - Caperchione, M. Cristina AU - Hargreaves, Nicole AU - Sabiston, M. Catherine AU - Berg, Stephen AU - Kowalski, C. Kent AU - Ferguson, J. Leah PY - 2020/6/9 TI - Exploring the Effectiveness of an Integrated Physical Activity and Psychosocial Program Targeting At-Risk Adolescent Girls: Protocol for the Girls United and on the Move (GUM) Intervention Study JO - JMIR Res Protoc SP - e15302 VL - 9 IS - 6 KW - adolescence KW - girls KW - at-risk KW - self-compassion KW - sport enjoyment KW - physical activity KW - community-based intervention N2 - Background: Adolescents are highly susceptible to negative self-perceptions, likely due to their social cues and environment. The presence of these negative self-perceptions has been shown to adversely impact levels of physical activity (PA). Although PA has the ability to foster improved self-perceptions, the rates of PA among adolescents continue to descend, with girls appearing to be most susceptible to these declines. At-risk adolescent girls, who may experience a number of negative preceding lifestyle conditions, may be exceptionally vulnerable to declines in PA. There are a high number of adolescent girls from low-income and abusive households in British Columbia, Canada, thus indicating a need for a program to relay the importance of PA and healthy lifestyle behaviors. Objective: This paper aims to describe the protocol of the Girls United and on the Move (GUM) pragmatic intervention, an integrated PA and psychosocial program aimed at improving self-compassion, social connectedness, and overall self-perceptions among at-risk adolescent girls. Methods: Using a quasi-experimental mixed methods approach, the GUM intervention was conducted in 5 schools in British Columbia, Canada. Adolescent girls aged 11 to 15 years who were identified as at risk were included in the study. The 9-week intervention, co-delivered by a PA/health promotion?trained researcher and a registered social worker, involved a PA component and a psychosocial component with evidence-based topics addressing the concerns of the adolescent girls. The following outcomes were evaluated: PA, self-compassion, social support, leader supportiveness, and sport enjoyment and commitment. Program acceptability and satisfaction was also examined. Outcome measures were assessed at baseline (week 1), week 6, and postintervention (week 9), and interview data concerning program acceptability and satisfaction were collected at postintervention from a subsample of participants. Results: A total of 101 participants were invited to participate in the GUM intervention. Reporting of the results is projected for the fall of 2020. Conclusions: It is anticipated that the GUM intervention will enhance PA while also improving self-compassion, social connectedness, and overall self-perceptions among at-risk adolescent girls. The findings of this research will contribute to the literature concerning PA and various psychosocial factors that impact the physical and mental health of at-risk adolescent girls. Trial Registration: Clinicaltrials.gov NCT03567200; https://clinicaltrials.gov/ct2/show/NCT03567200. International Registered Report Identifier (IRRID): DERR1-10.2196/15302 UR - http://www.researchprotocols.org/2020/6/e15302/ UR - http://dx.doi.org/10.2196/15302 UR - http://www.ncbi.nlm.nih.gov/pubmed/32515748 ID - info:doi/10.2196/15302 ER -