Actively Recruiting
Led by Children's Hospital of Fudan University · Updated on 2026-03-19
240
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating the effects of auricular acupressure compared to intermittent carbohydrate restriction on cardiometabolic risk factors in children with obesity and a traditional Chinese medicine diagnosis of gastric heat and dampness obstruction. The study focuses on childhood obesity, which is linked to increased risks of high blood sugar, abnormal blood lipids, and high blood pressure that can lead to complications in adulthood. This trial aims to explore these two approaches over three months to understand their impact on cardiovascular metabolic health. Participants are randomly assigned to one of two treatment groups. One group receives auricular acupressure therapy where specific ear acupoints are pressed with a patch containing vaccaria seed once daily before and after meals for 2-3 days, with weekly follow-ups, over a 3-month period. The other group follows an intermittent low carbohydrate diet, restricting carbohydrates to 50 grams per day for 7 days within every 2-week period, including a 1-month intervention and a 2-month self-maintenance phase. All participants receive weekly health education on obesity, cardiometabolic risks, and lifestyle changes such as caloric restriction and increased physical activity during the 3-month intervention. During the study, researchers monitor participants' body weight changes from baseline to one month post-intervention as the primary outcome. Secondary outcomes include changes in traditional Chinese medicine syndrome scores, glucose metabolism, waist-to-height ratio, body mass index, blood pressure, body fat content, blood lipids, liver and kidney function, gut microbiota, and dietary and exercise habits over three months. The study includes regular follow-ups and assessments to track these measures, supporting a comprehensive evaluation of the interventions' effects on childhood obesity and cardiometabolic health.
CONDITIONS
Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants receive either auricular acupressure therapy or intermittent low carbohydrate diet combined with weekly health education over a 3-month period.
Weekly visits for health education and follow-up
Duration - 2 months
Participants maintain lifestyle changes during a 2-month self-maintenance period following the 1-month intervention diet, with continued assessments.
Visits as scheduled for assessments during self-maintenance
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, China, 201102
Actively Recruiting
W
Weili Yan
W
Wen Sun
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Wen Sun, Jingwei He, Wenqin Wang...
https://pubmed.ncbi.nlm.nih.gov/40053799