JMIR Publications

ABSTRACT

Background:

Childhood obesity frequently persists into adulthood and is associated with an increased risk and earlier onset of cardiovascular disease in later life. Behavioural change strategies have been proposed as the first-line weight management approaches for children and adolescents with obesity. Non-pharmacological interventions, such as Traditional Chinese Medicine (TCM) auricular acupressure treatment and intermittent low-carbohydrate diet (ILCD), are increasingly investigated in young obese population. However, high-quality evidence about effectiveness and safety in weight control and reducing cardiometabolic risk in pediatric population.

Objective:

To compare the effect on cardiometabolic risk reduction between TAAT and ILCD in overweight/obese children with gastric-heat and dampness-obstruction syndrome.

Methods:

This is a randomized controlled trial. Eligible participants were overweight/obese children 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) aged between 6 and 18 years; (2) be overweight; (3) have gastric-heat and dampness-obstruction syndrome. Recruited children will be randomized in a 3:1 ratio to receive either TCM auricular acupressure treatment（TAAT） or a self-administered ILCD for one month,150 for the TAAT group and 50 for the ILCD group respectively. The primary outcome was the change in body weight from beginning of treatment to the end of one month. Secondary outcomes included body weight, waist circumference, 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 one month and three months, respectively. Primary statistical analyses were conducted using the Intention-To-Treat (ITT) strategy. A Generalized Linear Model (GLM) 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 mean difference in body weight change and its 95% confidence interval (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 5 May 2023 Before recruiting. Recruitment began in June 2023 and is expected to be completed by December 2025.By November 2024, we have enrolled 112 participants.

Conclusions:

This randomized trial will provide evidence on the treatment effects and safety of TAAT versus ILCD on overweight/obese children with gastric-heat and dampness-obstruction syndrome, in reducing body weight and improving cardiometabolic risks. Exploratory aims include potential underlying mechanisms of the two kinds of interventions, based on biosamples. Clinical Trial: ClinicalTrials.gov Review Board NCT05847478.