Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children

Официальное название

Effects of Intermittent Dietary Restriction on Cardiometabolic Risk in School-aged Children: A Randomized Controlled Trial

Обзор

This randomized trial aims to evaluate the health-promoting effects of intermittent dietary restrictions, including intermittent low-carbohydrate diet (ILCD) and calorie restriction (ICR), in school-aged children with cardiometabolic risk (CMR) compared with general health education based on dietary and physical activity guidelines for Chinese children.

Подробное описание

Childhood obesity comorbid with one or more CMR factors, including hyperglycemia, dyslipidemia, and hypertension, predicts an increased risk for developing cardiovascular disease in adulthood. Lifestyle interventions, including restricting dietary calorie intake and increasing physical activity, have been proposed as the first-line behavioral weight management approaches for pediatric obesity. Long-term adherence to daily dietary restriction is challenging for young populations because they are in a particular period of physical and psychological growth and lifestyle formation. Low-carbohydrate diet and ICR have shown effectiveness in improving cardiometabolic health in adults, however, the evidence supporting the effects of these diets in pediatric populations remains limited.

Eligible participants will be randomized to receive intermittent dietary restriction, including an ILCD (carbohydrate intake ≤ 50 g/d for two days per week) or an ICR (calorie intake is 500-600 kcal/d for two days per week), or general health education based on dietary and physical activity guidelines for Chinese children in daily life. The total study duration will be 12 months consisting of a 3-month intervention phase and a 9-month self-maintenance phase.

Вмешательства

• Поведенческое Intermittent dietary restriction
  Intermittent dietary restriction will include the ILCD and ICR, which will be self-administered interventions in daily lives. The ILCD intervention will ask participants to restrict carbohydrate intake to ≤ 50 g/d on two consecutive or discontinuous days per week. The ICR intervention will ask participants to restrict caloric intake to 600 kcal/d for boys and 500 kcal/d for girls on two consecutive or discontinuous days per week. At baseline, participants will receive face-to-face oral dietary
• Поведенческое General health education
  General health education based on dietary and physical activity guidelines for Chinese children and adolescents, will regularly send offline and online promotional materials to participants.

Первичные конечные точки

• Number of participants with reversal of at least one cardiometabolic abnormalities [Срок оценки: At month 3 from baseline]

Вторичные конечные точки (8)

• Number of participants with reversal of at least one cardiometabolic abnormalities [Срок оценки: At month 12 from baseline]
• Change in body fat (%) [Срок оценки: From baseline to month 3]
• Change in the total score of the Wechsler Intelligence Scale for Children [Срок оценки: From baseline to month 3]
• Change in body weight [Срок оценки: From baseline to month 3]
• Change in body weight [Срок оценки: From baseline to month 12]
• Change in waist circumference [Срок оценки: From baseline to month 3]
• Change in waist circumference [Срок оценки: From baseline to month 12]
• Change in fibroblast growth factor 21 (FGF-21) [Срок оценки: From baseline to month 3]

Критерии участия

Критерии включения

• Aged 7-18 years at baseline.
• At least one of the following cardio-metabolic abnormalities:

• Prediabetes (Impaired fasting glucose: 5.6 ≤ fasting blood glucose level ≤ 6.9 mmol/L; or Impaired glucose tolerance: 7.8 ≤ blood glucose level after 2 hours postprandial ≤ 11.0 mmol/L).
• Lipid abnormalities (High-density lipoprotein cholesterol ≤ 1.04 mmol/L; or Low-density lipoprotein cholesterol ≥ 3.37 mmol/L; or Triglycerides ≥ 1.70 mmol/L, or Total cholesterol ≥ 5.18 mmol/L).
• Elevated blood pressure (Systolic/diastolic blood pressure consistently higher than the 90th percentile for gender, age, and height; or systolic/diastolic blood pressure ≥ 120/80 mmHg).

Критерии исключения

• Previously diagnosed with heart failure, severe malnutrition, immune deficiency, liver or kidney disease, cancer, or other diseases deemed unsuitable for participation.
• Had a history of bariatric surgery.
• Used weight loss pills or supplements in the last three months.
• Other situations unsuitable for participation.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT06500078 · IM_Diet_2.0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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