TY  - JOUR
AU  - Sun, Wen
AU  - He, Jingwei
AU  - Wang, Wenqin
AU  - Lu, Chen
AU  - Lin, Yating
AU  - Dou, Yalan
AU  - Yan, Weili
AU  - Yu, Jian
PY  - 2025
DA  - 2025/3/3
TI  - Auricular Acupressure Versus an Intermittent Low-Carbohydrate Diet in Children With Overweight or Obesity With Gastric-Heat and Dampness-Obstruction Syndrome: Protocol for a Randomized Controlled Trial
JO  - JMIR Res Protoc
SP  - e59856
VL  - 14
KW  - children with obesity
KW  - traditional Chinese medicine
KW  - TCM auricular acupressure treatment
KW  - intermittent low carbohydrate diet
KW  - study protocol
AB  - Background: Childhood obesity frequently persists into adulthood and is associated with an increased risk and earlier onset of cardiovascular disease in later life. Behavioral change strategies have been proposed as the first-line weight management approach for children and adolescents with obesity. Nonpharmacological interventions, such as traditional Chinese medicine (TCM) auricular acupressure treatment and intermittent low-carbohydrate diet (ILCD), are increasingly being investigated in the young obese population. However, there is limited high-quality evidence about effectiveness and safety in weight control and reducing cardiometabolic risk in the pediatric population. Objective: This study aimed to compare the effect of cardiometabolic risk reduction between TCM auricular acupressure treatment (TAAT) and ILCD in children with overweight or obesity with gastric-heat and dampness-obstruction syndrome. Methods: This is a randomized controlled trial. Eligible participants are children with overweight or obesity and enrolled at the obesity clinic of the department of TCM at a tertiary children’s hospital. Eligible participants must meet the following criteria: (1) be aged between 6 and 18 years, (2) be overweight, and (3) have gastric-heat and dampness-obstruction syndrome. Recruited children will be randomized 3:1 to receive either TAAT or a self-administered ILCD for 1 month: 150 in the TAAT group and 50 in the ILCD group. The primary outcome is the change in body weight from the beginning of treatment to the end of 1 month. Secondary outcomes included body weight, waist circumference, waist-to-height ratio, BMI, blood pressure, body fat content, indexes of liver and renal function, indexes of glucose metabolism, gut microbiota, and TCM syndrome scores at the end of 1 month and 3 months, respectively. Primary statistical analyses were conducted using the intention-to-treat strategy. A generalized linear model was used to compare the difference in weight change between the groups, with the baseline body weight as the covariate, to obtain the estimate of the mean difference in body weight change and its 95% CI, using Gaussian for family function and identity for link function. Results: The study protocol was approved by the institutional ethical committee and registered on ClinicalTrials.gov on May 5, 2023, before recruitment. Recruitment began in June 2023 and is expected to be completed by December 2025. As of November 2024, we have enrolled 112 participants. Conclusions: This randomized controlled trial will provide evidence on the treatment effects and safety of TAAT versus ILCD among children with overweight or obesity with gastric-heat and dampness-obstruction syndrome, in reducing body weight and improving cardiometabolic risks. Exploratory aims include potential underlying mechanisms of the 2 kinds of interventions, based on biosamples. Trial Registration: ClinicalTrials.gov NCT05847478. https://clinicaltrials.gov/study/NCT05847478 International Registered Report Identifier (IRRID): DERR1-10.2196/59856 
SN  - 1929-0748
UR  - https://www.researchprotocols.org/2025/1/e59856
UR  - https://doi.org/10.2196/59856
UR  - http://www.ncbi.nlm.nih.gov/pubmed/40053799
DO  - 10.2196/59856
ID  - info:doi/10.2196/59856
ER  -