Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2024-09-28
2026-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Childhood obesity: BMI-z score \> 2.
* Agree to participate in this study and signed an informed consent form.
Exclusion Criteria
* 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).
8 Years
17 Years
ALL
No
Sponsors
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Soochow University
OTHER
Xiaoyan Shi
OTHER
Responsible Party
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Xiaoyan Shi
Associate Chief Physician
Locations
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Children's Hopital of Soochow University
Suzhou, Jiangsu, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Hao Peng, PhD
Role: primary
Xiaoyan Shi, PhD
Role: backup
Xiaoyan Shi, PhD
Role: backup
Jian Wang, PhD
Role: backup
Mengxuan Ye, MBBS
Role: primary
Xiaoyan Shi, PhD
Role: backup
Xiaoyan Shi, PhD
Role: backup
References
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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.
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.
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.
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.
Other Identifiers
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ChiCTR2400088243
Identifier Type: OTHER
Identifier Source: secondary_id
TRECO-suzhou
Identifier Type: -
Identifier Source: org_study_id