Futuros Fuertes 2.0 A Primary Care Based Intervention to Prevent Obesity Among Low-income Latino Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 576
- 试验地点
- 4
- 主要终点
- BMI Z-score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Days 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Infant has a serious medical condition that affects feeding or growth
研究组 & 干预措施
Intervention
The Futuros Fuertes 2.0 intervention includes brief health education and coaching at well child visits in the first two years of life that addresses optimal feeding, screen time and sleep practices. In addition, caregivers receive 2 text messages per week. Caregivers also receive environmental prompts to help support healthy behaviors at home.
干预措施: Futuros Fuertes 2.0 (Behavioral)
Control
The control intervention includes brief health education and coaching at well child visits in the first two years of life that addresses home safety, management of common childhood illnesses, and promotion of language development. In addition, caregivers receive 2 text messages per week. Caregivers also receive environmental prompts to help support healthy behaviors at home.
干预措施: Control (Behavioral)
结局指标
主要结局
BMI Z-score
时间窗: 24-months
BMI Z-score based on WHO growth curves
次要结局
- Breastfeeding(First year of life)
- Screen time(24-months)
- Sleep duration(24-months)
- Fruit and vegetable intake(24-months)
- Sugar sweetened beverage and 100% fruit juice intake(24-months)
- Change in BMI Z-score(6-months to 24-months)