Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control (TRE-SFR-EX)
2026年7月21日 更新者：Peking University
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
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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
300
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 18 to 50 years, all sexes.
- Body mass index (BMI) >=28 kg/m2.
- 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%.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：App-Supported Exercise
Participants receive exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks.
The program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
|
Participants receive individualized exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks.
The exercise program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
|
|
实验性的：Staple Food Reduction Plus App-Supported Exercise
Participants reduce staple food intake by approximately one half at three meals without restriction of eating time and receive the same app-supported exercise intervention for 12 weeks.
|
Participants receive individualized exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks.
The exercise program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
Participants reduce staple food intake by approximately one half at three meals without restriction of eating time.
This dietary strategy is combined with the same app-supported exercise intervention.
|
|
实验性的：Early Time-Restricted Eating Plus App-Supported Exercise
Participants consume food only from 07:00 to 15:00 each day, with water allowed outside the eating window, without prescribed restriction of total daily energy intake, and receive the same app-supported exercise intervention for 12 weeks.
|
Participants receive individualized exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks.
The exercise program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
Participants consume food only from 07:00 to 15:00 each day, with water allowed outside the eating window.
Total daily energy intake is not prescribed, and participants are advised to follow the Chinese Dietary Guidelines.
This dietary strategy is combined with the same app-supported exercise intervention.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in body weight from baseline to week 12
大体时间：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.
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Baseline and week 12
|
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Change in CGM-derived glucose exposure and time in range from baseline to week 12
大体时间：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.
|
Baseline and week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in BMI from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Calculated as weight in kg divided by height in meters squared (kg/m²).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in body fat mass from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Change in body fat mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
|
Baseline, week 12, and week 24
|
|
Change in fasting plasma glucose from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Fasting plasma glucose will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in systolic blood pressure from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Systolic blood pressure will be measured in millimeters of mercury (mmHg).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
|
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Change in CGM-derived mean glucose from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Mean glucose will be calculated from valid CGM readings and reported in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Questionnaire-based measures include dietary intake, physical activity, sleep, psychological status, appetite, and intervention adherence.
|
Baseline, week 12, and week 24
|
|
Adverse events and serious adverse events
大体时间：From baseline through week 24
|
Adverse events and serious adverse events will be collected throughout the intervention and follow-up period and summarized by randomized group.
|
From baseline through week 24
|
|
Change in Waist circumference from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Measured in centimeters (cm).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in Hip circumference from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Measured in centimeters (cm).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Calculated as a unitless ratio.
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in body fat percentage from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Change in body fat percentage (measured in %) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
|
Baseline, week 12, and week 24
|
|
Change in skeletal muscle mass from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Change in skeletal muscle mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
|
Baseline, week 12, and week 24
|
|
Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Glycated hemoglobin (HbA1c) will be measured as a percentage.
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in fasting plasma insulin from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Fasting plasma insulin will be measured in microunits per milliliter (µIU/mL).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in homeostatic model assessment of insulin resistance from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated from fasting plasma glucose and fasting plasma insulin and reported as a unitless index.
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in diastolic blood pressure from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Diastolic blood pressure will be measured in millimeters of mercury (mmHg).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in heart rate from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Heart rate will be measured in beats per minute (bpm).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in total cholesterol from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Fasting serum total cholesterol will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in triglycerides from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Fasting serum triglycerides will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in low-density lipoprotein cholesterol from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Fasting serum low-density lipoprotein cholesterol (LDL-C) will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Fasting serum high-density lipoprotein cholesterol (HDL-C) will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in alanine aminotransferase from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Serum alanine aminotransferase (ALT) will be measured in units per liter (U/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in aspartate aminotransferase from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Serum aspartate aminotransferase (AST) will be measured in units per liter (U/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in serum creatinine from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Serum creatinine will be measured in micromoles per liter (µmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in serum uric acid from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Serum uric acid will be measured in micromoles per liter (µmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in CGM-derived time above range from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Time above range (TAR) will be calculated as the percentage of valid CGM readings above 10.0 mmol/L.
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in CGM-derived time below range from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
Time below range (TBR) will be calculated as the percentage of valid CGM readings below 3.9 mmol/L.
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in CGM-derived glucose coefficient of variation from baseline to week 12 and week 24
大体时间：Baseline, week 12, and week 24
|
The glucose coefficient of variation (CV) will be calculated from valid CGM readings and reported as a percentage.
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2027年4月1日
研究注册日期
首次提交
2026年7月13日
首先提交符合 QC 标准的
2026年7月21日
首次发布 (实际的)
2026年7月24日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月21日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00001052-26093
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared publicly because the study includes sensitive health information and biological sample data.
De-identified aggregate results will be reported in scientific publications.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.