Time Restricted Eating in Childhood Obesity: An Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Change in BMI-Z score
研究概览
简要总结
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:
- Is the weight-losing effect of 12-hour TRE better than CRD?
- 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:
- Follow the 12-hour TRE or CRD diet every day for 48 weeks;
- Visit the clinic once every 4 weeks before 12 weeks and thereafter every 12 weeks for checkups and tests;
- Keep a diary of their diet, physical activity, and symptoms
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 8-17 years.
- •Childhood obesity: BMI-z score >
- •Agree to participate in this study and signed an informed consent form.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Calorie-restricted diet (CRD) (Behavioral)
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.
干预措施: Time-restricted eating (TRE) (Behavioral)
结局指标
主要结局
Change in BMI-Z score
时间窗: 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.
次要结局
- 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)
- Adherence(From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively)
- Energy intake(Every week from enrollment to the end of treatment at 48 weeks)
- Change in hemoglobin A1c(From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively)
- Change in low density lipoprotein cholesterol(From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively)
- Change in systolic blood pressure(From enrollment to the end of treatment at 12 (stage 1) and 48 (stage 2) weeks respectively)
研究者
Xiaoyan Shi
Associate Chief Physician
Children's Hospital of Soochow University