Time Restricted Eating in Childhood Obesity (TRECO)
NCT Number: NCT06583447
Acronym: TRECO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Childhood Obesity
Sponsor: shixiaoyan
Sex: ALL
Age: CHILD
Enrollment: 128
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-12-31

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. 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

Primary Outcome Measures: 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 Outcome Measures: 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|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