Time Restricted Eating in Childhood Obesity (TRECO)

NCT06583447 | Recruiting DMC

• 2 other identifiers: TRECO-suzhouChiCTR2400088243
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.Is the weight-losing effect of 12-hour TRE better than CRD?
2. 2.Is 12-hour TRE easier to adhere to than CRD?
3. 3.Follow the 12-hour TRE or CRD diet every day for 48 weeks;
4. 4.Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests;
5. 5.Keep a diary of their diet, physical activity, and symptoms

Conditions

Childhood Obesity

Keywords

Childhood Obesity; Calory-restricted diet; time-restricted eating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Weight attainment rate

  From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively

• Change in body composition

  From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively

• Quality of life

  From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively

• Sleep quality

  From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively

• Eating behavior

  From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively

Study Arms (2)

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.

Behavioral: Calorie-restricted diet (CRD)

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.

Behavioral: Time-restricted eating (TRE)

Interventions

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.

CRD group

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.

TRE group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 8-17 years.
• Childhood obesity: BMI-z score \> 2.
• Agree to participate in this study and signed an informed consent form.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xiaoyan Shi: lead
• Soochow University: collaborator

Study Sites (2)

Children's Hopital of Soochow University

Suzhou, Jiangsu, 215123, China

NOT YET RECRUITING

Children's Hospital of Soochow University

Suzhou, Jiangsu, 215123, China

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Intermittent Fasting

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Hao Peng, PhD

CONTACT

+86 051265880079; penghao@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 4, 2024
• Study Start: September 28, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)