An interventional study of App-Supported Exercise Intervention and Staple Food Reduction in Obesity; Impaired Glucose Regulation; Prediabetes; Type 2 Diabetes Mellitus, sponsored by Peking University. Not yet recruiting. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Peking University · Not applicable, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 300 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Peking University is the lead sponsor of 419 studies on the registry; 123 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks. The program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
Behavioral: App-Supported Exercise Intervention
Participants reduce staple food intake by approximately one half at three meals without restriction of eating time and receive the same app-supported exercise intervention for 12 weeks.
Behavioral: App-Supported Exercise Intervention · Behavioral: Staple Food Reduction
Participants consume food only from 07:00 to 15:00 each day, with water allowed outside the eating window, without prescribed restriction of total daily energy intake, and receive the same app-supported exercise intervention for 12 weeks.
Behavioral: App-Supported Exercise Intervention · Behavioral: Early Time-Restricted Eating
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.
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.
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.
Change in body weight from baseline to 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.
Time frame: Baseline and week 12
Change in CGM-derived glucose exposure and time in range from baseline to 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.
Time frame: Baseline and week 12
Change in BMI from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in body fat mass from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in fasting plasma glucose from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in systolic blood pressure from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in CGM-derived mean glucose from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24
Questionnaire-based measures include dietary intake, physical activity, sleep, psychological status, appetite, and intervention adherence.
Time frame: Baseline, week 12, and week 24
Adverse events and serious adverse events
Adverse events and serious adverse events will be collected throughout the intervention and follow-up period and summarized by randomized group.
Time frame: From baseline through week 24
Change in Waist circumference from baseline to week 12 and week 24
Measured in centimeters (cm). Changes will be compared among the three randomized groups.
Time frame: Baseline, week 12, and week 24
Change in Hip circumference from baseline to week 12 and week 24
Measured in centimeters (cm). Changes will be compared among the three randomized groups.
Time frame: Baseline, week 12, and week 24
Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24
Calculated as a unitless ratio. Changes will be compared among the three randomized groups.
Time frame: Baseline, week 12, and week 24
Change in body fat percentage from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in skeletal muscle mass from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24
Glycated hemoglobin (HbA1c) will be measured as a percentage. Changes will be compared among the three randomized groups.
Time frame: Baseline, week 12, and week 24
Change in fasting plasma insulin from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in homeostatic model assessment of insulin resistance from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in diastolic blood pressure from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in heart rate from baseline to week 12 and week 24
Heart rate will be measured in beats per minute (bpm). Changes will be compared among the three randomized groups.
Time frame: Baseline, week 12, and week 24
Change in total cholesterol from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in triglycerides from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in low-density lipoprotein cholesterol from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in high-density lipoprotein cholesterol from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in alanine aminotransferase from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in aspartate aminotransferase from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in serum creatinine from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in serum uric acid from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in CGM-derived time above range from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in CGM-derived time below range from baseline to 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.
Time frame: Baseline, week 12, and week 24
Change in CGM-derived glucose coefficient of variation from baseline to 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.
Time frame: Baseline, week 12, and week 24
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared publicly because the study includes sensitive health information and biological sample data. De-identified aggregate results will be reported in scientific publications.
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Dec 2026, 5 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 5 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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