Time Restricted Eating in Childhood Obesity (TRECO)

Official title

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

Overview

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

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.

Interventions

• 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 o
• 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

Primary outcome measures

• Change in BMI-Z score [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]

Secondary outcome measures (10)

• Weight attainment rate [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]
• Change in body composition [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]
• Quality of life [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]
• Sleep quality [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]
• Eating behavior [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]
• Adherence [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]
• Energy intake [Time frame: Every week from enrollment to the end of treatment at 48 weeks]
• Change in hemoglobin A1c [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 [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]
• Change in systolic blood pressure [Time frame: From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively]

Eligibility 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Children's Hopital of Soochow University — Suzhou
• Children's Hospital of Soochow University — Suzhou

Publications

• 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. PMID 35194176
• 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. PMID 31881139
• 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. PMID 22087679
• 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. PMID 29617589
• Shi X, Jiang P, Wang P, Guo X, Ye M, Jiang Z, Chen Y, Fan T, Mao G, Zhou C, Zhao L, Zhang M, Wu L, Wang J, Peng H. Study protocol for a randomized clinical trial to reduce weight among youth with obesity using time-restricted eating: the TRECO study. BMC Pediatr. 2025 Dec 3;26(1):21. doi: 10.1186/s12887-025-06298-w. PMID 41340042

Identifiers

NCT: NCT06583447 · TRECO-suzhou · ChiCTR2400088243

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)
• ChiCTR ChiCTR2400088243 (Chinese Clinical Trial Registry)

View this study on ClinicalTrials.gov ↗