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Идёт набор NCT06489262

Efficacy Trial of Healthy Together ("Juntos")

Без фазы С лечением Obesity Activity, Motor Diet, Healthy

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: Healthy Together ("Juntos").
Кому может быть актуально
Состояния в реестре: Obesity, Activity, Motor, Diet, Healthy. Базовые параметры: 12 лет — 15 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
США
Следующий шаг
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Официальное название

Efficacy Trial of Healthy Together "Juntos": A Family-based Digital Lifestyle Intervention for Hispanic Adolescents and Their Parents

Обзор

The purpose of this study is to assess the efficacy of a family-based digital (web and mobile phone-based) program known as Healthy Together ("Juntos") in preventing increases in body mass index and improving moderate-to-vigorous physical activity, diet quality, and percentage body fat among Hispanic adolescents.

Вмешательства

  • Поведенческое Healthy Together ("Juntos")
    Parent-adolescent dyads will log in to a secured website for six months. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention

Первичные конечные точки

  • Change in Body Mass Index (BMI) in adolescents [Срок оценки: Baseline and up to 12 months]
Вторичные конечные точки (10)
  • Change in Moderate-to-Vigorous Physical Activity (MVPA) in adolescents [Срок оценки: Baseline and up to 12 months]
  • Change in Diet Quality in adolescents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool [Срок оценки: Baseline and up to 12 months]
  • Change in Percentage of Body Fat in adolescents [Срок оценки: Baseline and up to 12 months]
  • Change in Body Mass Index (BMI) in parents [Срок оценки: Baseline and up to 12 months]
  • Change in Moderate-to-Vigorous Physical Activity (MVPA) in parents [Срок оценки: Baseline and up to 12 months]
  • Change in Diet Quality in parents measured by National Cancer Institute (NCI) Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool [Срок оценки: Baseline and up to 12 months]
  • Change in Percentage of Body Fat in parents [Срок оценки: Baseline and up to 12 months]
  • Change in Parenting Practices measured by the Parental involvement Scale [Срок оценки: Baseline and up to 12 months]
  • Change in Communication measured by Parent Adolescent Communication Scale [Срок оценки: Baseline and up to 12 months]
  • Change in Health-related Positive Parenting Practices measured by the Parenting Strategies for Eating and Activity Scale [Срок оценки: Baseline and up to 12 months]

Критерии участия

Критерии включения

Adolescent

  • Lives with participating biological parent or legal guardian;
  • Self-identifies as Hispanic;
  • Is between the ages of 12-15years old;
  • Has access to a smartphone;
  • Does not meet recommendations for physical activity as determined by a validated 2-item screener;
  • Does not meet recommendations for daily fruit and vegetable intake (proxy for diet quality) as determined by a validated 2-item screener;
  • Exceeds recommendations for screen time (proxy for sedentary behavior) as determined by a validated 6-item screener

Parent

  • Is the biological parent or legal guardian of and lives with the adolescent;
  • Self-identifies as Hispanic;
  • Has access to a smartphone;

Критерии исключения

Adolescent

  • Has BMI <5th (underweight) or ≥95th percentile (obesity);
  • Has a parent-reported chronic medical condition (e.g., type 2 diabetes) that requires more intensive intervention;
  • Has parent-reported responses on a physical activity readiness questionnaire (PAR-Q) that indicates a serious health issue, and a physician does not approve participation;
  • Has a parent-reported cognitive or developmental delay (e.g., Down Syndrome) that may interfere with understanding program materials.

Parent

  • Provides PAR-Q responses that indicate a serious health issue and a physician does not approve participation;
  • Reports family plans to move out of South Florida during the study follow-up period

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
  • University of Miami — Miami

Идентификаторы

NCT: NCT06489262 · 20231382 · R01CA289519

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗