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.
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