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Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control (TRE-SFR-EX)

21 luglio 2026 aggiornato da: Peking University

A Multicenter Randomized Controlled Trial of Time-Restricted Eating, Staple Food Reduction, and App-Supported Exercise for Weight Loss and Glycemic Improvement in Adults With Obesity and Abnormal Glucose Metabolism

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

300

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: App-Supported Exercise
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.
Comportamentale: 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.
Sperimentale: Staple Food Reduction Plus App-Supported Exercise
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.
Comportamentale: 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.
Comportamentale: 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.
Sperimentale: Early Time-Restricted Eating Plus App-Supported Exercise
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.
Comportamentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in body weight from baseline to week 12
Lasso di tempo: 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.
Baseline and week 12
Change in CGM-derived glucose exposure and time in range from baseline to week 12
Lasso di tempo: 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.
Baseline and week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in BMI from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in body fat mass from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in fasting plasma glucose from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in systolic blood pressure from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in CGM-derived mean glucose from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24
Lasso di tempo: Baseline, week 12, and week 24
Questionnaire-based measures include dietary intake, physical activity, sleep, psychological status, appetite, and intervention adherence.
Baseline, week 12, and week 24
Adverse events and serious adverse events
Lasso di tempo: 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.
From baseline through week 24
Change in Waist circumference from baseline to week 12 and week 24
Lasso di tempo: Baseline, week 12, and week 24
Measured in centimeters (cm). Changes will be compared among the three randomized groups.
Baseline, week 12, and week 24
Change in Hip circumference from baseline to week 12 and week 24
Lasso di tempo: Baseline, week 12, and week 24
Measured in centimeters (cm). Changes will be compared among the three randomized groups.
Baseline, week 12, and week 24
Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24
Lasso di tempo: Baseline, week 12, and week 24
Calculated as a unitless ratio. Changes will be compared among the three randomized groups.
Baseline, week 12, and week 24
Change in body fat percentage from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in skeletal muscle mass from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24
Lasso di tempo: Baseline, week 12, and week 24
Glycated hemoglobin (HbA1c) will be measured as a percentage. Changes will be compared among the three randomized groups.
Baseline, week 12, and week 24
Change in fasting plasma insulin from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in homeostatic model assessment of insulin resistance from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in diastolic blood pressure from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in heart rate from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in total cholesterol from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in triglycerides from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in low-density lipoprotein cholesterol from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in alanine aminotransferase from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in aspartate aminotransferase from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in serum creatinine from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in serum uric acid from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in CGM-derived time above range from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in CGM-derived time below range from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24
Change in CGM-derived glucose coefficient of variation from baseline to week 12 and week 24
Lasso di tempo: 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.
Baseline, week 12, and week 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University

Collaboratori

Chinese PLA General Hospital
Qingdao Municipal Hospital
Beijing Pinggu District Hospital
Dongying Traditional Chinese Medicine Hospital
Ningbo Beilun Community Health Service Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 dicembre 2026

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

13 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2026

Primo Inserito (Effettivo)

24 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB00001052-26093

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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