Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control (TRE-SFR-EX)
2026년 7월 21일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
300
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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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.
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실험적: 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.
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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.
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실험적: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in body weight from baseline to week 12
기간: Baseline and week 12
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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
기간: Baseline and week 12
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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.
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Baseline and week 12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in BMI from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Calculated as weight in kg divided by height in meters squared (kg/m²).
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 body fat mass from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Change in body fat mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
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Baseline, week 12, and week 24
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Change in fasting plasma glucose from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Fasting plasma glucose will be measured in millimoles per liter (mmol/L).
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 systolic blood pressure from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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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
기간: Baseline, week 12, and week 24
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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.
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Baseline, week 12, and week 24
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Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Questionnaire-based measures include dietary intake, physical activity, sleep, psychological status, appetite, and intervention adherence.
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Baseline, week 12, and week 24
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Adverse events and serious adverse events
기간: From baseline through week 24
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Adverse events and serious adverse events will be collected throughout the intervention and follow-up period and summarized by randomized group.
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From baseline through week 24
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Change in Waist circumference from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Measured in centimeters (cm).
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 Hip circumference from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Measured in centimeters (cm).
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 Waist-to-hip ratio (WHR) from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Calculated as a unitless ratio.
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 body fat percentage from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Change in body fat percentage (measured in %) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
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Baseline, week 12, and week 24
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Change in skeletal muscle mass from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Change in skeletal muscle mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
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Baseline, week 12, and week 24
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Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Glycated hemoglobin (HbA1c) will be measured as a percentage.
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 fasting plasma insulin from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Fasting plasma insulin will be measured in microunits per milliliter (µIU/mL).
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 homeostatic model assessment of insulin resistance from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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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.
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Baseline, week 12, and week 24
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Change in diastolic blood pressure from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Diastolic 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 heart rate from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Heart rate will be measured in beats per minute (bpm).
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 total cholesterol from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Fasting serum total cholesterol will be measured in millimoles per liter (mmol/L).
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 triglycerides from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Fasting serum triglycerides will be measured in millimoles per liter (mmol/L).
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 low-density lipoprotein cholesterol from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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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.
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Baseline, week 12, and week 24
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Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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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.
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Baseline, week 12, and week 24
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Change in alanine aminotransferase from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Serum alanine aminotransferase (ALT) will be measured in units per liter (U/L).
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 aspartate aminotransferase from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Serum aspartate aminotransferase (AST) will be measured in units per liter (U/L).
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 serum creatinine from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Serum creatinine will be measured in micromoles per liter (µmol/L).
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 serum uric acid from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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Serum uric acid will be measured in micromoles per liter (µmol/L).
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 time above range from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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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.
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Baseline, week 12, and week 24
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Change in CGM-derived time below range from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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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.
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Baseline, week 12, and week 24
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Change in CGM-derived glucose coefficient of variation from baseline to week 12 and week 24
기간: Baseline, week 12, and week 24
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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.
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Baseline, week 12, and week 24
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2027년 4월 1일
연구 등록 날짜
최초 제출
2026년 7월 13일
QC 기준을 충족하는 최초 제출
2026년 7월 21일
처음 게시됨 (실제)
2026년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 21일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB00001052-26093
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
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아니
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아니
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