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.
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.
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.
Parallel
App-Supported Exercise Intervention
BehavioralParticipants 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.
Staple Food Reduction
BehavioralParticipants 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.
Early Time-Restricted Eating
BehavioralParticipants 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.
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.
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.
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.
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.
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.
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.
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Peking University
Lead sponsor
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
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