Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control (TRE-SFR-EX)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: App-Supported Exercise Intervention; Behavioral: Staple Food Reduction; Behavioral: Early Time-Restricted Eating

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: App-Supported Exercise Intervention; 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.
Experimental: 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.	Behavioral: App-Supported Exercise Intervention; 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.; Behavioral: Staple Food Reduction; 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.
Experimental: 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.	Behavioral: App-Supported Exercise Intervention; 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.; Behavioral: Early Time-Restricted Eating; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight from baseline to 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.	Baseline and week 12
Change in CGM-derived glucose exposure and time in range from baseline to 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI from baseline to 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	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	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	Systolic 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 CGM-derived mean glucose from baseline to 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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Chinese PLA General Hospital; Qingdao Municipal Hospital; Beijing Pinggu District Hospital; Dongying Traditional Chinese Medicine Hospital; Ningbo Beilun Community Health Service Center

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: time-restricted eating; staple food reduction; app-supported exercise; obesity; abnormal glucose metabolism; continuous glucose monitoring
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Fasting; Obesity; Diabetes Mellitus, Type 2; Prediabetic State; Intermittent Fasting
• Other Study ID Numbers: IRB00001052-26093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No