An interventional study of Calorie-restricted diet (CRD) and Time-restricted eating (TRE) in Childhood Obesity, sponsored by Xiaoyan Shi. Recruiting at 2 sites in China. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Xiaoyan Shi · Not applicable, Interventional, and Treatment
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:
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:
Childhood obesity is a major metabolic disorder affecting approximately 20% of children and adolescents. Calory-restricted diet (CRD) is the primary treatment for obesity, but adherence to CRD typically declines over time and many individuals who lose weight with this strategy regain it. Accumulating evidence suggests that time-restricted eating (TRE), an alternative method of reducing energy intake that has gained popularity in recent years, has a significant weight-losing effect on adult obesity. However, its weight-losing effect on childhood obesity is still lacking trial evidence.
The overall objective of this study is to test the effectiveness of 12-hour TRE on weight loss for childhood obesity in comparison with CRD. The secondary objective is to compare the long-term adherence and weight-losing effect between the two dietary interventions.
The TRECO study is an open-label, blinded endpoint, parallel design, randomized controlled trial planned to enroll 128 patients with childhood obesity (8-17 years old, BMI-Z value >2), randomized by sex and age (12 years old) into zonal groups, and on the basis of the conventional non-pharmacological interventions, TRE was given to the intervention group, and CRD was given to the control group, and the short-term effect of TRE was observed after 12 weeks of intervention The short-term effect of TRE was observed after 12 weeks of intervention, i.e., to compare the difference in the magnitude of BMI-Z reduction between the two groups. The intervention was extended to 48 weeks to observe the long-term effect of TRE by comparing the difference in the reduction of BMI-Z between the two groups.
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 128 is above the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →This is the only study on the registry with Xiaoyan Shi as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Calorie-restricted diet (CRD)
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.
Behavioral: Time-restricted eating (TRE)
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.
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.
Change in BMI-Z score
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.
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Weight attainment rate
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. Weight attainment is defined as a BMI-Z score \<2.
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in body composition
Body composition is assessed by bioimpedance with a Tanita MC-780 BC instrument, available at the Hospital's Endocrinology department. We are monitoring the absolute amount and percentage of both total body fat and lean mass as well as abdominal fat mass at all time points.
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Quality of life
Quality of life scale for children and adolescents (QLSCA), a multi-dimensional self-evaluation scale for learning and life, covering physical, psychological, social function and living environment, is suitable for primary and middle school students aged 7 to 18.
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Sleep quality
Sleep quality was assessed by a total score of the Pittsburgh Sleep Quality Index (PSQI).
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Eating behavior
Children eating behavior questionnaire (Children's Eating Behavior Questionnaire, CEBQ) using 35 items, 8 subscale to assess children's eating behavior habits. CEBQ measures food "close" (food response, food enjoyment, emotional overeating, drink desire) and food "avoidance" (satiety reaction, eating slowly, picky, and emotional deficiency) eating behavior.
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Adherence
Leveraging dietary diary, the compliance will be assessed by days when study subjects completed the dietary intervention program.
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Energy intake
24 hour meal review through the whole study
Time frame: Every week from enrollment to the end of treatment at 48 weeks
Change in hemoglobin A1c
Blood biochemical analyzer was used to detect hemoglobin A1c as the indicator of glucose metabolism.
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in low density lipoprotein cholesterol
Blood biochemical analyzer was used to detect low density lipoprotein cholesterol to assess lipids metabolism.
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Change in systolic blood pressure
Sitting blood pressure was measured three times at resting state, with the mean as blood pressure. Systolic blood pressure was used to assess the blood pressure control..
Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively
Plan to share: No — The protocol of this study will be published in open peer-reviewed journals very soon.
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