Strong Futures: A Pilot Randomized Controlled Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Parent health-related quality of life
研究概览
简要总结
Latino children experience higher rates of obesity compared to non-Hispanic white children, especially in low-income communities. Optimal feeding strategies in early life, avoidance of screen time and longer sleep duration may lower the risk of obesity. Family financial hardship is also associated with short- and long-term health risks, including behavioral and mental health problems, and toxic stress which contributes to elevated risk of common chronic conditions over the life course. This proposal aims to pilot test two interventions to promote optimal health outcomes in Latino infants. Study participants will meet with a health educator after well child visits at 2-weeks, 2-, 4-, 6-, 9- and 12-months. Half of the parents will receive education on obesity prevention. The other half will receive financial education and case management using an established financial coaching approach. Parents will also receive text messages that reinforce educational content. The objective of this study is to determine the acceptability and feasibility of offering these interventions in the well-child setting. Study investigators also seek to determine the preliminary efficacy of these interventions on infant and parent health outcomes including dietary intake, screen time, sleep duration, health related quality of life and financial stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study investigators will recruit parents who self-identify as Latino and their newborn infants
- •Infants must be born at Zuckerberg San Francisco General Hospital (ZSFG)
- •Infants must be singletons
- •Parents must intend to receive primary care for their infant at Zuckerberg San Francisco General Hospital
- •Parents must speak Spanish (but may also speak English)
排除标准
- •Infants with birth weights less than 2500 grams
- •Infants born prior to 37 weeks and 0 days gestation
- •Infants with any medical condition that significantly affects feeding, such as infants who are unable to feed by mouth
- •Infants with any medical condition that is known to be associated with failure to thrive or specialized nutritional needs
- •Infants in foster care
- •Infants for whom the primary caregiver is not the infant's mother or father
结局指标
主要结局
Parent health-related quality of life
时间窗: Child age 15-months
Assessed by the PROMIS-10. The Patient Reported Outcome Measurement Information System Global Short Form 10 (PROMIS-10) is a ten-item scale measuring health related quality of life with subscales for physical and mental health. Raw overall total PROMIS-10 scale scores range from 10-50, with sub-scale T-scores that range from 16-67 for physical health and 21-68 for mental health. For all PROMIS-10 total raw and sub-scale scores, higher scores indicate better health-related quality of life.
Child screen time
时间窗: Child age 15-months
Total minutes of daily screen time
Child dietary intake
时间窗: 15-months
Total child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.
次要结局
- Child anthropometrics(Child ages 6-months, 12-months, 15-months and 24-months)
- Child sleep(Child age 15-months)
- Parent financial stress(Child age 15-months)
- Parental feeding styles(15-months)
