Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control (TRE-SFR-EX)
21 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Estimado)
300
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
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.
|
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Experimental: 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.
|
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.
|
|
Experimental: 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.
|
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 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in body weight from baseline to week 12
Periodo de tiempo: 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.
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Baseline and week 12
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Change in CGM-derived glucose exposure and time in range from baseline to week 12
Periodo de tiempo: Baseline and week 12
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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.
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Baseline and week 12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in BMI from baseline to week 12 and week 24
Periodo de tiempo: Baseline, week 12, and week 24
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Calculated as weight in kg divided by height in meters squared (kg/m²).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
|
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Change in body fat mass from baseline to week 12 and week 24
Periodo de tiempo: 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.
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Baseline, week 12, and week 24
|
|
Change in fasting plasma glucose from baseline to week 12 and week 24
Periodo de tiempo: 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.
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Baseline, week 12, and week 24
|
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Change in systolic blood pressure from baseline to week 12 and week 24
Periodo de tiempo: 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.
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Baseline, week 12, and week 24
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Change in CGM-derived mean glucose from baseline to week 12 and week 24
Periodo de tiempo: 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.
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Baseline, week 12, and week 24
|
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Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24
Periodo de tiempo: Baseline, week 12, and week 24
|
Questionnaire-based measures include dietary intake, physical activity, sleep, psychological status, appetite, and intervention adherence.
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Baseline, week 12, and week 24
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Adverse events and serious adverse events
Periodo de tiempo: 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.
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From baseline through week 24
|
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Change in Waist circumference from baseline to week 12 and week 24
Periodo de tiempo: Baseline, week 12, and week 24
|
Measured in centimeters (cm).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
|
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Change in Hip circumference from baseline to week 12 and week 24
Periodo de tiempo: Baseline, week 12, and week 24
|
Measured in centimeters (cm).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
|
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Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24
Periodo de tiempo: Baseline, week 12, and week 24
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Calculated as a unitless ratio.
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in body fat percentage from baseline to week 12 and week 24
Periodo de tiempo: Baseline, week 12, and week 24
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Change in body fat percentage (measured in %) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
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Baseline, week 12, and week 24
|
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Change in skeletal muscle mass from baseline to week 12 and week 24
Periodo de tiempo: 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
|
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Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24
Periodo de tiempo: 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
|
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Change in fasting plasma insulin from baseline to week 12 and week 24
Periodo de tiempo: 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
|
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Change in homeostatic model assessment of insulin resistance from baseline to week 12 and week 24
Periodo de tiempo: 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.
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Baseline, week 12, and week 24
|
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Change in diastolic blood pressure from baseline to week 12 and week 24
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Change in total cholesterol from baseline to week 12 and week 24
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Change in low-density lipoprotein cholesterol from baseline to week 12 and week 24
Periodo de tiempo: 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
|
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Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24
Periodo de tiempo: 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
|
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Change in alanine aminotransferase from baseline to week 12 and week 24
Periodo de tiempo: 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
|
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Change in aspartate aminotransferase from baseline to week 12 and week 24
Periodo de tiempo: 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
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Change in serum creatinine from baseline to week 12 and week 24
Periodo de tiempo: 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
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Change in serum uric acid from baseline to week 12 and week 24
Periodo de tiempo: 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
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Change in CGM-derived time above range from baseline to week 12 and week 24
Periodo de tiempo: 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.
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Baseline, week 12, and week 24
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Change in CGM-derived time below range from baseline to week 12 and week 24
Periodo de tiempo: Baseline, week 12, and week 24
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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
|
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Change in CGM-derived glucose coefficient of variation from baseline to week 12 and week 24
Periodo de tiempo: 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.
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Baseline, week 12, and week 24
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2026
Publicado por primera vez (Actual)
24 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Exceso de peso
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Comportamiento de alimentación
- Ayuno
- Obesidad
- Diabetes Mellitus, Tipo 2
- Estado prediabético
- Ayuno intermitente
Otros números de identificación del estudio
- IRB00001052-26093
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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