A Multicenter Randomized Controlled Trial of Time-Restricted Eating, Staple Food Reduction, and App-Supported Exercise for Weight Loss and Glycemic Improvement in Adults With Obesity and Abnormal Glucose Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Change in body weight from baseline to week 12
研究概览
简要总结
This multicenter, three-arm randomized controlled trial will evaluate the effects of early time-restricted eating and staple food reduction, each combined with an app-supported exercise intervention, on body weight and glycemic control among adults with obesity and abnormal glucose metabolism. A total of 300 participants aged 18 to 50 years with BMI >=28 kg/m2 and impaired glucose regulation or diabetes will be enrolled at five centers in China and randomized 1:1:1 to app-supported exercise alone, staple food reduction plus app-supported exercise, or early time-restricted eating plus app-supported exercise. The intervention lasts 12 weeks, followed by a 12-week post-intervention follow-up.
详细描述
All groups will use the Xiangdong Health app for exercise prescriptions, self-monitoring, and behavioral feedback. The staple food reduction group will reduce staple food intake by approximately one half at three meals without restriction of eating time. The early time-restricted eating group will consume food only between 07:00 and 15:00, with water allowed outside the eating window, without prescribed restriction of total daily energy intake. Outcomes will be measured at baseline, week 12, and week 24, including body weight, glycemic indices, continuous glucose monitoring metrics, body composition, blood pressure, blood biochemistry, urine tests, stool microbiome, dietary recall, physical activity, sleep, appetite, psychological measures, adherence, and adverse events.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 50 years, all sexes.
- •Body mass index (BMI) >=28 kg/m
- •Willing and able to comply with study procedures and provide written informed consent.
- •Resident living near a participating study site and able to complete scheduled visits.
- •No habitual time-restricted eating or other fasting regimen, such as alternate-day fasting or fasting-mimicking diet.
- •Abnormal glucose metabolism or diabetes, defined as fasting plasma glucose >5.6 mmol/L or HbA1c >5.7%.
排除标准
- •Secondary obesity, such as hypothyroidism or Cushing syndrome.
- •Use of weight-loss medication within 90 days before screening, or body weight change >5 kg within 90 days before screening.
- •Pregnant, lactating, or planning pregnancy during the study period.
- •Severe cardiac, hepatic, or renal dysfunction.
- •Severe psychiatric disease or cognitive impairment that prevents cooperation with the study.
- •Contraindication to exercise, such as severe osteoarthritis.
- •Unable or unwilling to follow the study diet and exercise intervention.
- •Long-term use of medications that may significantly affect body weight.
- •Active malignancy in any organ system.
- •Any other condition that, in the investigator's judgment, may affect efficacy or safety evaluation or make the participant unsuitable for the study.
结局指标
主要结局
Change in body weight from baseline to week 12
时间窗: Baseline and week 12
Body weight will be measured using a calibrated scale. The primary analysis will compare absolute change in body weight from baseline to week 12 among the three randomized groups.
Change in CGM-derived glucose exposure and time in range from baseline to week 12
时间窗: Baseline and week 12
Continuous glucose monitoring (CGM) metrics will include glucose area under the curve and time in range (TIR), defined as the percentage of valid CGM readings between 3.9 and 10.0 mmol/L. Changes from baseline to week 12 will be compared among the three randomized groups.
次要结局
- Change in BMI from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in body fat mass from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in fasting plasma glucose from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in systolic blood pressure from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in CGM-derived mean glucose from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Adverse events and serious adverse events(From baseline through week 24)
- Change in Waist circumference from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in Hip circumference from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in body fat percentage from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in skeletal muscle mass from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in fasting plasma insulin from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in homeostatic model assessment of insulin resistance from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in diastolic blood pressure from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in heart rate from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in total cholesterol from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in triglycerides from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in low-density lipoprotein cholesterol from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in alanine aminotransferase from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in aspartate aminotransferase from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in serum creatinine from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in serum uric acid from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in CGM-derived time above range from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in CGM-derived time below range from baseline to week 12 and week 24(Baseline, week 12, and week 24)
- Change in CGM-derived glucose coefficient of variation from baseline to week 12 and week 24(Baseline, week 12, and week 24)