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Идёт набор NCT07296861

HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome

Без фазы С лечением Down Syndrome Child Obesity

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: The HomeGrown, Waitlist.
Кому может быть актуально
Состояния в реестре: Down Syndrome, Child Obesity. Базовые параметры: Без ограничений · 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
США
Следующий шаг
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Обзор

The goal of this project is to evaluate an adapted health promotion program, HomeGrown, designed to improve the health of young children with Down syndrome by supporting families in making healthy home environmental changes. There is a significant need for evidence-based programs that address healthy eating and physical activity within this population, as most existing interventions have been developed for typically developing children. By tailoring the program to the unique needs of families of young children with Down syndrome, this project aims to advance inclusion and equity in health behavior promotion. This R61/R33 study will assess the feasibility (R61 Phase) and subsequent efficacy (R33 Phase) of the HomeGrown program in improving family practices related to nutrition and physical activity. During the R61 feasibility phase, 38 primary caregivers of children aged 2-6 years with Down syndrome will be enrolled in a 6-month randomized controlled trial. Families will be randomized 1:1 to either the HomeGrown intervention or a waitlist control group (6-month delayed start), stratified by the child's biological sex (male/female) and age (2-3 vs. 4-6 years). All measures will be collected at baseline and at 6-month follow-up. The R61 feasibility phase will address three specific aims: Accrual: Achieve an enrollment rate of 10 families per month, supporting feasibility for the R33 efficacy phase. Engagement: Demonstrate that families use at least 70% of available HomeGrown intervention components, measured using the digital behavior change interventions engagement scale. Data Collection \& Retention: Achieve at least 80% retention with completion of all outcome assessments. By addressing key gaps in nutrition and physical activity research for young children with Down syndrome, this study has the potential to improve health outcomes for an underserved population and inform future clinical and community health promotion efforts.

Вмешательства

  • Поведенческое The HomeGrown
    The implementation model for supporting home environment changes focuses on engaging families in Homegrown, giving them access to interactive online tools and resources that guide behavior change, and providing monthly support check-in calls as they work to adopt evidence-based healthy eating and physical activity practices at home. Families will participate in the 6-month program with support from a trained health educator. The HomeGrown program begins with a family orientation session, followe
  • Другое Waitlist
    Participants will have a 1-hour training with the interventionist to learn how to use a website (not HomeGrown). Access to HomeGrown will be provided after the 6-month study is completed.

Первичные конечные точки

  • Accrual Rate [Срок оценки: Baseline]
  • Participant Engagement [Срок оценки: 6 months]
  • Participant Retention [Срок оценки: 6 months]
Вторичные конечные точки (2)
  • Child Physical Activity [Срок оценки: 6 months]
  • Child Diet Quality [Срок оценки: 6 months]

Критерии участия

Критерии включения

Adult:

  • Ability to provide informed consent
  • 18 years or older
  • Primary caregiver of a child with Down syndrome aged 2 to 6 years old
  • Have access to WI-FI or smartphone
  • Be able to read and speak English

Children:

  • Be 2-6 years old.
  • Are diagnosed with Down syndrome
  • Are not reliant on tube feeding

Критерии исключения

\-

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

США · 1 центр
  • UNC Center for Health Promotion and Disease Prevention — Chapel Hill

Идентификаторы

NCT: NCT07296861 · 25-2418 · R01DK128174

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗