A Primary Care Based Intervention to Prevent Childhood Obesity Among Low-income Latino Children

Официальное название

Futuros Fuertes 2.0 A Primary Care Based Intervention to Prevent Obesity Among Low-income Latino Children

Обзор

The goal of this study is to evaluate the impact of a primary care based intervention to promote optimal feeding, screen time and sleep practices among low-income Latino infants and toddlers. Infants and caregivers will receive brief health education and coaching sessions from health educators at primary care visits in the first two years of life as well as two text messages per week with health information and tips. Half of the participants will receive the Futuros Fuertes 2.0 intervention that includes health coaching and education on infant feeding, screen time and sleep (intervention group). The other half will receive health coaching and education on safety, home management of childhood illnesses, and promotion of language development (control group). We will look at the impact of the Futuros Fuertes 2.0 intervention on child BMI and various health behaviors.

Вмешательства

• Поведенческое Control
  The control intervention includes brief health education and coaching sessions just after well child visits in the first two years of life (total of 7 sessions), 2 text messages per week for the primary caregiver and up to two additional family members, and environmental prompts that support healthy behaviors. The control intervention focuses on home safety, home management of common childhood illnesses, and promotion of language development.
• Поведенческое Futuros Fuertes 2.0
  The Futuros Fuertes 2.0 intervention includes brief health education and coaching sessions just after well child visits in the first two years of life (total of 7 sessions), 2 text messages per week for the primary caregiver and up to two additional family members, and environmental prompts that support healthy behaviors. The Futuros Fuertes 2.0 intervention focuses on optimal infant feeding, screen time, and sleep practices.

Первичные конечные точки

• BMI Z-score [Срок оценки: 24-months]

Вторичные конечные точки (6)

• Breastfeeding [Срок оценки: First year of life]
• Screen time [Срок оценки: 24-months]
• Sleep duration [Срок оценки: 24-months]
• Fruit and vegetable intake [Срок оценки: 24-months]
• Sugar sweetened beverage and 100% fruit juice intake [Срок оценки: 24-months]
• Change in BMI Z-score [Срок оценки: 6-months to 24-months]

Критерии участия

Критерии включения

• Parent/caregiver self identifies as Latino
• Parent/caregiver speaks Spanish or English
• Parent/caregiver intends to receive primary care for infant at participating clinic
• Infant gestational age of 37 weeks or greater
• Infant birthweight of 2600 grams or greater
• For multiples (twins, triplets), one sibling will be chosen at random to participate

Критерии исключения

-Infant has a serious medical condition that affects feeding or growth

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

Профилактика

Центры проведения

США · 2 центра

• Children's Health Center San Francisco General Hospital — San Francisco
• Valley Health Center Sunnyvale — Sunnyvale

Идентификаторы

NCT: NCT06398509 · 23-38707 · 1R01HD109158

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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