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

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

Interventions

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.

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.

Sponsors & Collaborators

• Chinese PLA General Hospital

  collaborator OTHER

• Beijing Pinggu District Hospital

  collaborator OTHER

• Dongying Traditional Chinese Medicine Hospital

  collaborator UNKNOWN

• Ningbo Beilun Community Health Service Center

  collaborator UNKNOWN

• Qingdao Municipal Hospital

  collaborator OTHER

• Peking University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2026-12-31

Completion

2027-04-30