Time Restricted Eating in Childhood Obesity (TRECO) (TRECO)

Time Restricted Eating in Childhood Obesity: An Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical 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

Study Overview

• Status: Recruiting
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Calorie-restricted diet (CRD); Behavioral: Time-restricted eating (TRE)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Peng, PhD; Phone Number: +86 051265880079; Email: penghao@suda.edu.cn

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215123
      • Not yet recruiting
      • Children's Hopital of Soochow University
      • Contact: Hao Peng, PhD; Phone Number: +86 051265880079; Email: penghao@suda.edu.cn
      • Contact: Xiaoyan Shi, PhD; Phone Number: +86 51280693533; Email: xyshi@suda.edu.cn
      • Principal Investigator: Xiaoyan Shi, PhD
      • Sub-Investigator: Jian Wang, PhD
    • Suzhou, Jiangsu, China, 215123
      • Recruiting
      • Children's Hospital of Soochow University
      • Contact: Xiaoyan Shi, PhD; Phone Number: +86 51280693533; Email: xyshi@suda.edu.cn
      • Contact: Mengxuan Ye, MBBS; Phone Number: 18801542468; Email: 624442531@qq.com
      • Principal Investigator: Xiaoyan Shi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Calorie-restricted diet (CRD); 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.
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.	Behavioral: Time-restricted eating (TRE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	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.	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	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.	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.	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..	From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively

Collaborators and Investigators

• Sponsor: Xiaoyan Shi
• Collaborators: Soochow University

Publications and helpful links

General Publications

• Juonala M, Magnussen CG, Berenson GS, Venn A, Burns TL, Sabin MA, Srinivasan SR, Daniels SR, Davis PH, Chen W, Sun C, Cheung M, Viikari JS, Dwyer T, Raitakari OT. Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med. 2011 Nov 17;365(20):1876-85. doi: 10.1056/NEJMoa1010112.
• Varady KA, Cienfuegos S, Ezpeleta M, Gabel K. Clinical application of intermittent fasting for weight loss: progress and future directions. Nat Rev Endocrinol. 2022 May;18(5):309-321. doi: 10.1038/s41574-022-00638-x. Epub 2022 Feb 22.
• Bjerregaard LG, Jensen BW, Angquist L, Osler M, Sorensen TIA, Baker JL. Change in Overweight from Childhood to Early Adulthood and Risk of Type 2 Diabetes. N Engl J Med. 2018 Apr 5;378(14):1302-1312. doi: 10.1056/NEJMoa1713231.
• de Cabo R, Mattson MP. Effects of Intermittent Fasting on Health, Aging, and Disease. N Engl J Med. 2019 Dec 26;381(26):2541-2551. doi: 10.1056/NEJMra1905136. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Childhood Obesity; time-restricted eating; Calory-restricted diet
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Fasting; Pediatric Obesity; Intermittent Fasting; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Energy Intake; Caloric Restriction
• Other Study ID Numbers: TRECO-suzhou; ChiCTR2400088243 (Other Identifier: ChiCTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The protocol of this study will be published in open peer-reviewed journals very soon.
• IPD Sharing Time Frame: The IPD and supporting information will be available at the end of study at 2026.12.31 for two years.
• IPD Sharing Access Criteria: All researchers can access to the data on reasonable request from Hao Peng (penghao@suda.edu.cn).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No