Time-restricted eating for treating childhood obesity
Time Restricted Eating in Childhood Obesity: An Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
This study is testing if a 12-hour eating schedule can help kids aged 8-17 with obesity lose more weight and stick to their diet better than a regular calorie-restricted diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Children's Hospital of Soochow University Academic / other |
| Locations | 2 sites (Suzhou, Jiangsu and 1 other locations) |
| Trial ID | NCT06583447 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a 12-hour time-restricted eating (TRE) regimen compared to a traditional calorie-restricted diet (CRD) in treating childhood obesity. Participants aged 8-17 with a BMI-Z score greater than 2 will follow either the TRE or CRD diet for 48 weeks, with regular check-ups and dietary diaries to monitor adherence and weight loss. The study seeks to determine if TRE leads to greater weight loss and better adherence than CRD, addressing a significant gap in obesity treatment for children.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-17 years with a BMI-Z score greater than 2 who are willing to participate.
Not a fit: Patients who have been actively fasting for more than 12 hours a day or those with certain medical conditions, such as diabetes or psychiatric disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and sustainable dietary intervention for managing childhood obesity.
How similar studies have performed: While time-restricted eating has shown promise in adult populations, this study represents a novel approach as there is limited trial evidence for its effectiveness in children.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 8-17 years. * Childhood obesity: BMI-z score \> 2. * Agree to participate in this study and signed an informed consent form. Exclusion Criteria: * Individuals who have been actively fasting for more than 12 hours/day. * Diabetic patients on hypoglycemic medications. * Individuals undergoing weight loss interventions or previous bariatric surgery. * Individuals with psychiatric, intellectual developmental disorders, or aphasia. * Individuals on appetite or weight-suppressing medications within the last three months (e.g., antipsychotics, hypnotics, weight-loss drugs, insulin).
Where this trial is running
Suzhou, Jiangsu and 1 other locations
- Children's Hopital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
- Children's Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Hao Peng, PhD
- Email: penghao@suda.edu.cn
- Phone: +86 051265880079
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.