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NCT Number: NCT06583447

Time Restricted Eating in Childhood Obesity (TRECO)

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

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Key information

Conditions

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

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hopital of Soochow University, Suzhou, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in BMI-Z score

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

    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.

Secondary outcomes

  1. Weight attainment rate

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

    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.

  2. Change in body composition

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

    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.

  3. Quality of life

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

    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.

  4. Sleep quality

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

    Sleep quality was assessed by a total score of the Pittsburgh Sleep Quality Index (PSQI).

  5. Eating behavior

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

    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.

  6. Adherence

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

    Leveraging dietary diary, the compliance will be assessed by days when study subjects completed the dietary intervention program.

  7. Energy intake

    Time frame: Every week from enrollment to the end of treatment at 48 weeks

    24 hour meal review through the whole study

  8. Change in hemoglobin A1c

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

    Blood biochemical analyzer was used to detect hemoglobin A1c as the indicator of glucose metabolism.

  9. 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

    Blood biochemical analyzer was used to detect low density lipoprotein cholesterol to assess lipids metabolism.

  10. Change in systolic blood pressure

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

    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..

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Peng, PhD

CONTACT

[email protected]

+86 051265880079

Sponsors and collaborators

Lead sponsor

Xiaoyan Shi

Other

Collaborators

  • Soochow University

Registry information

Official study title

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

Acronym: TRECO

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 4, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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