Clinical trial
Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control
Opening soon · Not applicable · 0 countries · Registry ID NCT07726615
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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.
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.
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.
Primary outcomes
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.
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.
Study locations
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