Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Change in body weight from baseline to week 12 [Срок оценки: Baseline and week 12]
• Change in CGM-derived glucose exposure and time in range from baseline to week 12 [Срок оценки: Baseline and week 12]

Вторичные конечные точки (12)

• Change in BMI from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in body fat mass from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in fasting plasma glucose from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in systolic blood pressure from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in CGM-derived mean glucose from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Adverse events and serious adverse events [Срок оценки: From baseline through week 24]
• Change in Waist circumference from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in Hip circumference from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in body fat percentage from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]
• Change in skeletal muscle mass from baseline to week 12 and week 24 [Срок оценки: Baseline, week 12, and week 24]

Критерии участия

Критерии включения

• 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%.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07726615 · IRB00001052-26093

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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