Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus
Conditions
Keywords
time-restricted eating; staple food reduction; app-supported exercise; obesity; abnormal glucose metabolism; continuous glucose monitoring
Brief summary
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.
Detailed description
All groups will use the Xiangdong Health app for exercise prescriptions, self-monitoring, and behavioral feedback. The staple food reduction group will reduce staple food intake by approximately one half at three meals without restriction of eating time. The early time-restricted eating group will consume food only between 07:00 and 15:00, with water allowed outside the eating window, without prescribed restriction of total daily energy intake. Outcomes will be measured at baseline, week 12, and week 24, including body weight, glycemic indices, continuous glucose monitoring metrics, body composition, blood pressure, blood biochemistry, urine tests, stool microbiome, dietary recall, physical activity, sleep, appetite, psychological measures, adherence, and adverse events.
Interventions
BEHAVIORALApp-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.
BEHAVIORALStaple 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.
BEHAVIORALEarly 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.
Sponsors
Peking University
Chinese PLA General Hospital
Beijing Pinggu District Hospital
Dongying Traditional Chinese Medicine Hospital
Ningbo Beilun Community Health Service Center
Qingdao Municipal Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1:1 ratio using a computer-generated sequence, stratified by study center, with allocation concealment using sequentially numbered opaque sealed envelopes or a central randomization process.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight from baseline to week 12 | Baseline 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 12 | Baseline 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI from baseline to week 12 and week 24 | Baseline, 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 | Baseline, 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 | Baseline, 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 | Baseline, 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. |
| Change in CGM-derived mean glucose from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Mean glucose will be calculated from valid CGM readings and reported in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups. |
| Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Questionnaire-based measures include dietary intake, physical activity, sleep, psychological status, appetite, and intervention adherence. |
| Adverse events and serious adverse events | From baseline through week 24 | Adverse events and serious adverse events will be collected throughout the intervention and follow-up period and summarized by randomized group. |
| Change in Waist circumference from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Measured in centimeters (cm). Changes will be compared among the three randomized groups. |
| Change in Hip circumference from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Measured in centimeters (cm). Changes will be compared among the three randomized groups. |
| Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Calculated as a unitless ratio. Changes will be compared among the three randomized groups. |
| Change in body fat percentage from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Change in body fat percentage (measured in %) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis. |
| Change in skeletal muscle mass from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Change in skeletal muscle mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis. |
| Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Glycated hemoglobin (HbA1c) will be measured as a percentage. Changes will be compared among the three randomized groups. |
| Change in fasting plasma insulin from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Fasting plasma insulin will be measured in microunits per milliliter (µIU/mL). Changes will be compared among the three randomized groups. |
| Change in homeostatic model assessment of insulin resistance from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated from fasting plasma glucose and fasting plasma insulin and reported as a unitless index. Changes will be compared among the three randomized groups. |
| Change in diastolic blood pressure from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Changes will be compared among the three randomized groups. |
| Change in heart rate from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Heart rate will be measured in beats per minute (bpm). Changes will be compared among the three randomized groups. |
| Change in total cholesterol from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Fasting serum total cholesterol will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups. |
| Change in triglycerides from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Fasting serum triglycerides will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups. |
| Change in low-density lipoprotein cholesterol from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Fasting serum low-density lipoprotein cholesterol (LDL-C) will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups. |
| Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Fasting serum high-density lipoprotein cholesterol (HDL-C) will be measured in millimoles per liter (mmol/L). Changes will be compared among the three randomized groups. |
| Change in alanine aminotransferase from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Serum alanine aminotransferase (ALT) will be measured in units per liter (U/L). Changes will be compared among the three randomized groups. |
| Change in aspartate aminotransferase from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Serum aspartate aminotransferase (AST) will be measured in units per liter (U/L). Changes will be compared among the three randomized groups. |
| Change in serum creatinine from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Serum creatinine will be measured in micromoles per liter (µmol/L). Changes will be compared among the three randomized groups. |
| Change in serum uric acid from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Serum uric acid will be measured in micromoles per liter (µmol/L). Changes will be compared among the three randomized groups. |
| Change in CGM-derived time above range from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Time above range (TAR) will be calculated as the percentage of valid CGM readings above 10.0 mmol/L. Changes will be compared among the three randomized groups. |
| Change in CGM-derived time below range from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | Time below range (TBR) will be calculated as the percentage of valid CGM readings below 3.9 mmol/L. Changes will be compared among the three randomized groups. |
| Change in CGM-derived glucose coefficient of variation from baseline to week 12 and week 24 | Baseline, week 12, and week 24 | The glucose coefficient of variation (CV) will be calculated from valid CGM readings and reported as a percentage. Changes will be compared among the three randomized groups. |
Outcome results
None listed