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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR2400088243 | Other Identifier | ChiCTR |
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| Name | Class |
|---|---|
| Soochow University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRD group | Active Comparator | 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. |
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| TRE group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calorie-restricted diet (CRD) | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Peng, PhD | Contact | +86 051265880079 | penghao@suda.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hopital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | 215123 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35194176 | Result | 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. | |
| 31881139 | Result | 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. |
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The protocol of this study will be published in open peer-reviewed journals very soon.
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Time-restricted eating (TRE) | Behavioral | 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 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 |
| Children's Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215123 | China |
|
| 22087679 | Result | 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. |
| 29617589 | Result | 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. |
| 41340042 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |