Time Restricted Eating in Childhood Obesity (TRECO)
ConditionChildhood Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorXiaoyan Shi
About this trial
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 criteria
Qualifiers
Age: 8-17 years.
Childhood obesity: BMI-z score > 2.
Agree to participate in this study and signed an informed consent form.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Calorie-restricted diet (CRD)
- Time-restricted eating (TRE)
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xiaoyan Shi
Lead sponsor
Children's Hospital of Soochow University
Sponsor institution
Soochow University
Collaborator
Source ClinicalTrials.gov