RCTs - Protocols/Proposals (non-eHealth)

Normalization of Gastrointestinal Symptoms in Adults With Constipation With Daily Green Kiwifruit Consumption: Protocol for an Open-Label Intervention Study

Jasjot Maggo, Hwei Min Ng, Simone Birgit Bayer, Catherine L Wall, Caroline L Hoad, Luca Marciani, Jane Mullaney, Diana Cabrera, Karl Fraser, Janine M Cooney, Catrin S Günther, Tania Trower, Jeffery Tang, Olivier Gasser, Amber Milan, Warren C McNabb, Robin Spiller, Tamlin Conner, Chris Frampton, Meika Foster, Nicole C Roy, Richard B Gearry

JMIR Res Protoc 2026 (Jan 13); 15:e75286

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Virtual Mentored Implementation to Improve Care Transitions in Chronic Obstructive Pulmonary Disease: Protocol for a Pragmatic Implementation Study

Cathryn T Lee, Leah Traeger, Mahima Akula, April E Fegley, Jenna Goldstein, Kim Erwin, Laura J Damschroder, Jean Rommes, Hannah Pick, Andrew Auerbach, Peter Lindenauer, Wen Wan, Andrea Jackson Sagredo, Valerie G Press

JMIR Res Protoc 2026 (Jan 13); 15:e82043

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Cluster Randomized Controlled Trial to Promote Physical Activity Among Low-Resourced Mothers in New York City: Protocol for the Free Time for Wellness Effectiveness Trial

Jessica Watterson, Kate Magsamen-Conrad, Kajal Gokal, Ingrid Oakley-Girvan, Jennifer S Hirsch, Min Qian, Richard Buchsbaum, Charlene Niles, Kendra Van Horn, Stephanie Moshier, Andreina Martinez, Avery Garcia Flores, Sherece Laine, Marilisa Vega, Lauren C Houghton

JMIR Res Protoc 2026 (Jan 13); 15:e71381

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Ayurvedic Therapeutic Regimen as an Add-On to Optimized Conventional Management of Parkinson Disease: Protocol for an Exploratory Randomized Controlled Trial Evaluating Clinical, Cortical Excitability, Neuroimmune, and Autonomic Function Parameters

Umesh Chikkanna, Pramod Kumar Pal, Sophia Jameela, Rohan R Mahale, Nitish Kamble, Venkataram Shivakumar, Bharath Holla, Ravi Yadav, Vikram V Holla, Talakad Narasappa Sathyaprabha, Kaviraja Udupa, Srinibash Sahoo, Manjunath M Venkataswamy, Selva Ganapathy, Chandra Shekara Rao, Babita Yadav, Sreenithya M, Shivarama Varambally, Sulochana Bhat, Narayanam Srikanth, Kishore Kumar Ramakrishna

JMIR Res Protoc 2026 (Jan 09); 15:e83336

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The Effects of Multi-Theory Model–Based Behavior Change Intervention with Staircase Approach on Sedentary Lifestyle Among Community-Dwelling Older Adults: Study Protocol for a Randomized Controlled Trial

Subinuer Tuerdi, HuiLing Yang, Li He, Rong Yan, YaoYi Cui, XingHui Wang, ShanShan Dong, JiaYu Yang, KeQiang Zhang, Feng Li, YueWei Li

JMIR Res Protoc 2026 (Jan 06); 15:e81284

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The Effect of Virtual Reality–Based Social Cognitive Training for Autistic Adults: Protocol for STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) Randomized Clinical Trial

Johannes Andresen, Alberte C E Jeppesen, Anne Sofie Due, Lise Sandvig Mariegaard, Rizwan Parvaiz, Carsten Hjorthøj, Amy Elizabeth Pinkham, Merete Nordentoft, Gasper Letnar, Jens Richardt Møllegaard Jepsen, Louise Birkedal Glenthøj

JMIR Res Protoc 2026 (Jan 05); 15:e72854

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Effects of Oliceridine Versus Sufentanil on Postoperative Recovery Quality During Hysteroscopy Under Laryngeal Mask Airway Anesthesia: Protocol for a Single-Blind and Randomized Controlled Trial

YuHang Shou, JianSheng Luo, XianJie Zhang, WenHu Zhai, Jia Han

JMIR Res Protoc 2026 (Jan 02); 15:e84521

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Efficacy of an Ayurvedic Intervention as an Adjunct to Standard Care in Preventing Acute Pain Crises in Sickle Cell Anemia: Protocol for a Randomized Controlled Trial

U R Sekhar Namburi, Priya Thakare, Vaishali Kuchewar, Manish Deshmukh, Kalpana Kachare, Madhukar Tikas, Deepa Makhija, Bhogavalli Chandra Sekhara Rao, MN Suryawanshi, Satish Mahajan, Abha Sharma, N Srikanth, Ravinarayana Acharya

JMIR Res Protoc 2025 (Dec 31); 14:e76576

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Hidden Workers in Aging Australia: Protocol of Intersectionality-Informed Mixed Methods Study

Sora Lee, Woojin Kang, Lu Yang, Mehak Batra

JMIR Res Protoc 2025 (Dec 31); 14:e83401

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Cardio-Cerebral Protective Effect of Moxibustion on Phlegm-Dampness Type Hypertension: Protocol for a Randomized Controlled Trial

Ling Cheng, Ning Bai, Liang Zheng, Lulu Cao, Huangan Wu, Ruiping Wang, Chen Zhao, Yunli Shen, Haiyin Zhao, Gang Li, Bing Yang, Qinghui Yang, Yan Xing, Jianhong Cao, Yixing Wang, Ling Xu, Junjie Yan, Jie Cao, Yiyang Guo

JMIR Res Protoc 2025 (Dec 29); 14:e79158

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Effectiveness of Metformin Prolonged-Release Formulation on Achievement of Optimal Glycemic Control in Gestational Diabetes Mellitus: Protocol for a Pilot, Randomized, Double-Blind, Clinical Trial

Dittakarn Boriboonhirunsarn, Prasert Sunsaneevithayakul

JMIR Res Protoc 2025 (Dec 19); 14:e79855

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The 5 R’s of Indigenous Research as a Framework to Co-Design and Evaluate an Outdoor Play Program in Early Learning and Child Care Centers: Protocol for the Promoting Early Childhood Outside (PRO-ECO) 2.0 Wait-List Control Cluster Randomized Trial

Mariana Brussoni, Rachel Ramsden, Sheila Grieve, Dawn Mount, Emily Fox, Susan Herrington, Yingyi Lin, Stella Erasmus Johnson, Jean Lloyd, Enid Elliot, Emily Mlieczko, Andrea Lemire, Laranna Scott, Ashley Barrett, Emma Cottier, Ally Rice

JMIR Res Protoc 2025 (Dec 12); 14:e77956

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Comparative Evaluation of the Effectiveness of Demineralized Freeze-Dried Bone Allografts With Titanium Platelet-Rich Fibrin and Autologous Dentin Graft With Titanium Platelet-Rich Fibrin for Alveolar Socket Preservation: Protocol for a Randomized Controlled Trial

Shivani Thakre, Pavan Bajaj

JMIR Res Protoc 2025 (Dec 10); 14:e70649

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Effectiveness of Different Methods of Interdental Hygiene in Daily Practice Among Young Adults: Protocol for a Randomized, Single-Blind Controlled Trial

Florence Carrouel, Romain Lan, Ina Saliasi, Denis Bourgeois, Nicolas Benech, Audrey Murat-Ringot, Stéphane Viennot

JMIR Res Protoc 2025 (Dec 04); 14:e85154

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Quality of Life and Metabolomics Analysis in Response to Meal Kit Intervention During Perioperative Chemotherapy in Patients with Early-Stage Breast Cancer: Protocol for a Single-Center Phase Ⅱ Randomized Crossover Trial

Atsushi Fushimi, Eriko Taguchi, Makiko Kamio, Takashi Kazama, Azusa Fuke, Hiroko Nogi

JMIR Res Protoc 2025 (Dec 04); 14:e72715

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A Primary Care Program Based on Behavioral Reeducation and Abdominal Massage for Improving the Symptoms of Chronic Constipation: Protocol for a Randomized Controlled Trial

Cristina Segura-Bayona, Josep Vidal-Alaball, Anna Ramírez-Morros, Queralt Miró-Catalina, Anna Ruiz-Comellas

JMIR Res Protoc 2025 (Dec 04); 14:e72018

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Effectiveness and Cost-Effectiveness of a Stepped Model of Care for Musculoskeletal Disorders: Protocol for a Multiarm Randomized Controlled Trial (Edu-First Trial)

Jean-Sébastien Roy, Hugo Massé-Alarie, Marc-Olivier Dubé, Anne Marie Pinard, Martin Lamontagne, Gisela Sole, Jean Tittley, Maude Laberge, Frédérique Dupuis, Félix Fiset, Ildephonse Nduwimana, Eric McArthur, François Desmeules

JMIR Res Protoc 2025 (Nov 19); 14:e77574

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Exploring Subjective Well-Being in Human-Machine Interaction: Protocol for a Mixed Methods, Cross-Sectional Analysis in Manufacturing 5.0

Giulia Bassi, Valeria Orso, Silvia Salcuni, Luciano Gamberini

JMIR Res Protoc 2025 (Nov 14); 14:e73896

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Effects of Shallow Needling for Chronic Primary Insomnia: Protocol for a Randomized Controlled Trial

Wanqing Lin, Chenlin Wang, Jiajia Ye, Yingling Ye, Min Tang, Qianqian Hu, Bin Chen

JMIR Res Protoc 2025 (Nov 11); 14:e76501

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Efficacy of a Ready-to-Feed Starter Liquid Infant Formula Containing 2-Fucosyllactose and Lacto-N-Neotetraose in Chinese Infants: Protocol for a Double Blind, Randomized Controlled Trial

Ying Wang, Caroline Ivanne Le Roy, Jing Li, Shuping Han, Zhiwei Liu, Anirban Lahiry, Himanshu Sahu, Qiaoji Li, Jie Dong, Alric Mondragon, Tinu Mary Samuel, Wei Cai

JMIR Res Protoc 2025 (Oct 31); 14:e66489

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