Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control

NCT07726615 | Not Yet Recruiting

• 1 other identifier: IRB00001052-26093
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus

Keywords

time-restricted eating; staple food reduction; app-supported exercise; obesity; abnormal glucose metabolism; continuous glucose monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (28)

• 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

Study Arms (3)

App-Supported Exercise

ACTIVE COMPARATOR

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

Staple Food Reduction Plus App-Supported Exercise

EXPERIMENTAL

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; Behavioral: Staple Food Reduction

Early Time-Restricted Eating Plus App-Supported Exercise

EXPERIMENTAL

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; Behavioral: Early Time-Restricted Eating

Interventions

App-Supported Exercise Intervention BEHAVIORAL

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.

App-Supported Exercise; Early Time-Restricted Eating Plus App-Supported Exercise; Staple Food Reduction Plus App-Supported Exercise

Staple Food Reduction BEHAVIORAL

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.

Staple Food Reduction Plus App-Supported Exercise

Early Time-Restricted Eating BEHAVIORAL

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.

Early Time-Restricted Eating Plus App-Supported Exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Obesity; Prediabetic State; Diabetes Mellitus, Type 2; Intermittent Fasting

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1:1 ratio using a computer-generated sequence, stratified by study center, with allocation concealment using sequentially numbered opaque sealed envelopes or a central randomization process.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share