Time Restricted Eating in Childhood Obesity: an Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this clinical trial is to learn if time-restricted eating (TRE), an alternative method of reducing energy intake which has gained popularity in recent years, works to treat obesity in children. It will also learn about the safety and long-term adherence of 12-hour TRE, in comparison to calory restricted diet (CRD) . The main questions it aims to answer are: 1. Is the weight-losing effect of 12-hour TRE better than CRD? 2. Is 12-hour TRE easier to adhere to than CRD? Researchers will compare 12-hour TRE to CRD (the primary treatment for obesity) to see if 12-hour TRE works to treat childhood obesity. Participants will: 1. Follow the 12-hour TRE or CRD diet every day for 48 weeks; 2. Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests; 3. Keep a diary of their diet, physical activity, and symptoms
Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:
• Age: 8-17 years.
• Childhood obesity: BMI-z score \> 2.
• Agree to participate in this study and signed an informed consent form.
Locations
Other Locations
China
Children's Hopital of Soochow University
NOT_YET_RECRUITING
Suzhou
Children's Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Hao Peng, PhD
penghao@suda.edu.cn
+86 051265880079
Time Frame
Start Date:2024-09-28
Estimated Completion Date:2026-12-31
Participants
Target number of participants:128
Treatments
Active_comparator: CRD group
Based on the standardized lifestyle intervention, the study subjects in the control group will be treated with CRD. Total daily energy intake will be restricted to 80% of the energy requirement for each age group in the Dietary Reference Intakes of Nutrients for Chinese Residents DRIs 2013. A daily food diary will be kept at least one weekday and one weekend per week.
Experimental: TRE group
Based on the standardized lifestyle intervention, TRE is administered to the study subjects in the intervention group. The eating window is limited to 12 hours per day, with the last meal no later than 7:00 p.m., and the study subjects are free to choose their eating window. Energy intake is not restricted during the eating period, and calorie-free, sugar-free beverages (water, tea, coffee) are allowed during the fasting period. A daily food diary will be kept for at least one weekday and one weekend per week.