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

Not Yet RecruitingNA

Sponsor: Peking University

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

Interventions: App-Supported Exercise Intervention, Staple Food Reduction, Early Time-Restricted Eating

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.