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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 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

300

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in body weight from baseline to week 12
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in BMI from baseline to week 12 and week 24
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Peking University

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2026

Ukończenie studiów (Szacowany)

1 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

13 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 lipca 2026

Pierwszy wysłany (Rzeczywisty)

24 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00001052-26093

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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