Strong Futures: A Pilot Randomized Controlled Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 194
- Locations
- 1
- Primary Endpoint
- Parent health-related quality of life
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Infant Obesity Prevention
The infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.
Intervention: Infant obesity prevention (Behavioral)
Financial Coaching
The financial coaching arm will provide parents with education on basic financial literacy topics and coaching to help parents achieve financial goals.
Intervention: Financial coaching (Behavioral)
Outcomes
Primary Outcomes
Parent health-related quality of life
Time Frame: 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
Time Frame: Child age 15-months
Total minutes of daily screen time
Child dietary intake
Time Frame: 15-months
Total child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.
Secondary Outcomes
- Child sleep(Child age 15-months)
- Child anthropometrics(Child ages 6-months, 12-months, 15-months and 24-months)
- Parent financial stress(Child age 15-months)
- Parental feeding styles(15-months)