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

Opening soonNot applicableInterventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus

Full registry 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.

Treatments and study arms

App-Supported Exercise Intervention

Behavioral

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

Behavioral

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

Behavioral

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

Change in body weight from baseline to week 12Baseline and 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 12Baseline and 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.

Study locations

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No public site location was included in this record. Check the original registry for updates.