Clinical trial

Time Restricted Eating in Childhood Obesity (TRECO)

Recruiting now · Not applicable · 1 countries · Registry ID NCT06583447

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Years to 17 Years

SexAll

Healthy volunteersNot accepted

ConditionChildhood Obesity

Full registry 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).

Treatments and study arms

Calorie-restricted diet (CRD)

Behavioral

Standardized lifestyle interventions for all obese children and their parents will be constructed by endocrinologists and dietitians to increase physical activity and healthy eating habits. Physical activity interventions include decreasing time spent in sedentary activities, increasing the amount of physical activity, and recommending at least 60 minutes of moderate-intensity exercise per day. Individualized dietary counseling is provided to address the comorbidities in obese children. 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 for at least one weekday and one weekend per week.

Time-restricted eating (TRE)

Behavioral

Based on the standardized lifestyle intervention mentioned by the calorie-restricted diet (CRD) 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.

Primary outcomes

Change in BMI-Z scoreFrom enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively

Weight and height are monitored at all-time points with an electronic scale and stadiometer and combined to calculate BMI-Z score based on the WHO growth charts. Participants will wear minimal clothing during the height and weight measurements.