Comparing auricular acupressure and intermittent dietary restriction for obese children
Effects of Auricular Acupressure Versus Intermittent Dietary Restriction in Children With Gastric Heat and Dampness Obstruction: a Randomized Controlled Trial
This study is testing whether auricular acupressure or a low-carbohydrate diet can help obese children improve their health and reduce risks like high blood sugar and cholesterol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05847478 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of auricular acupressure and intermittent carbohydrate restriction on cardiometabolic health in obese children with gastric heat and dampness obstruction. Over three months, participants will receive either auricular acupressure, a traditional Chinese medicine technique, or follow an intermittent low-carbohydrate diet, alongside health education. The study aims to assess improvements in obesity-related health risks such as hyperglycemia and dyslipidemia, which are prevalent in this population.
Who should consider this trial
Good fit: Ideal candidates are obese children with at least one cardiometabolic risk factor and a diagnosis of gastric heat and dampness obstruction syndrome.
Not a fit: Patients with obesity due to genetic or endocrine diseases, or those with serious organic or mental health conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological interventions for managing obesity and its associated health risks in children.
How similar studies have performed: While auricular acupressure has shown promise in treating obesity, this specific combination of interventions is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have at least one of the following cardiometabolic risk factors: overweight or obesity, prediabetes, dyslipidemia or elevated blood pressure. * Traditional Chinese medical syndrome type is gastric heat and dampness obstruction syndrome. Exclusion Criteria: * Diagnosis of obesity associated with genetic or endocrine diseases, including hypercortisolism, polycystic ovary syndrome, primary hypothyroidism and hypothalamic obesity. * Participating in other clinical trials or have participated in other clinical trials in recent 3 months. * Diagnosis of organic diseases, including heart, liver, kidney and brain or infectious diseases and mental diseases.
Where this trial is running
Shanghai
- Children's Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Weili Yan
- Email: yanwl@fudan.edu.cn
- Phone: +86 02164931215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.