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Идёт набор NCT07159971

Family-Based Nutrition Intervention to Prevent Overweight and Obesity in School-Age Children.

Без фазы С лечением Overweight and/or Obesity Children - Malnutrition Preventing Malnutrition

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: School B, Control.
Кому может быть актуально
Состояния в реестре: Overweight and/or Obesity, Children - Malnutrition, Preventing Malnutrition. Базовые параметры: 5 лет — 9 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Мексика
Следующий шаг
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Официальное название

Family-based Intervention Model to Prevent Childhood Obesity Among Schoolage Children in Sonora, Mexico.

Обзор

This proposal aims to enhance the well being of schoolchildren and their families through a mobile application and multidisciplinary intervention model grounded in authoritative parenting principles and social cognitive theory.

Подробное описание

Childhood is recognized as a critical period of metabolic sensitivity, during which excess adiposity increases the likelihood of developing metabolic abnormalities in adulthood by approximately 70%, including hypertension, dyslipidemia, insulin resistance, hyperuricemia, and non-alcoholic fatty liver disease. In Mexico, overweight and obesity affect 35.5% of school-aged children, inevitably contributing to the growing prevalence of non-communicable chronic diseases. Data from ENSANUT 2018 place Sonora among the five states with the highest rates of obesity, with 22.2% of adolescents aged 12-19 years classified as obese. This epidemiological context highlights the pressing need for innovative strategies to promote prevention and early risk detection during childhood.

Evidence indicates that mobile health (mHealth) applications may effectively reduce body weight and prevent fat accumulation. Nevertheless, only a limited number of studies have applied mHealth interventions to prevent pediatric adiposity or to foster behavioral changes in comparison with conventional nutritional approaches. The proposed model incorporates a communication strategy designed to monitor participant needs, offer engagement incentives, and promote adherence to the study protocol.

The primary research question addresses whether a family-focused intervention can effectively improve eating patterns and food-related behaviors among students enrolled at "La Caridad" Educational Center in Nacozari de García, Sonora.

Вмешательства

  • Устройство School B
    Nutritional therapy supported by a mobile application.
  • Другое Control
    Conventional nutritional treatment.

Первичные конечные точки

  • Dietary behavior [Срок оценки: Six months]
  • Body index mass [Срок оценки: Six months]
  • Age [Срок оценки: Six months]
  • Feeding practices [Срок оценки: Six months]
  • Body weight [Срок оценки: Six months]
  • Phisical activity [Срок оценки: Six months]
  • Height [Срок оценки: Six months]
  • Fat mass [Срок оценки: Six months]
  • Fat-free mass [Срок оценки: Six months]
  • Glucose [Срок оценки: Six months]
Вторичные конечные точки (1)
  • Z-Score [Срок оценки: Six months]

Критерии участия

Критерии включения

  • Families of children between 5 and 9 years old.
  • Children without any medical or nutritional treatment for obesity.
  • Children classified as normal weight, overweight, or obese based on WHO (Z-score: height for age and BMI for age).
  • Offspring of mothers aged between 18 and 45 years at delivery.
  • Term infants from normoevolutive pregnancies without maternal comorbidities.
  • Families who have a cell phone with internet access and an installed camera.

Критерии исключения

  • Children who are currently suffering from a pathology that requires medication or special treatment
  • Mothers/Fathers/Guardians who are currently suffering from a pathology that requires medication or special treatment.
  • Children who have a physical/mental impairment to perform physical activities.
  • Children from surrogate mothers who have presented at least 2 of the 11 DSM-5 criteria for substance use disorder (alcohol, tobacco, cannabis, or other illegal drugs) before or during the participating child's gestation.
  • Children from multiple pregnancies.
  • Parents who do not own a smartphone compatible with the app will be excluded from this study (i.e., version 5.0 or higher for Android).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Мексика · 1 центр
  • "El globo" and "Servicios de Salud Lomas Altas" — México

Идентификаторы

NCT: NCT07159971 · 3738

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗