Strong Futures: A Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers

University of California San Francisco (UCSF)

Status: Completed

Conditions: Health-Related Quality of Life; Childhood Obesity

Treatments: Behavioral: Infant obesity prevention; Behavioral: Financial coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03438721

17-24028

1K23HD080876-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

194 participants in 2 patient groups

Infant Obesity Prevention

Experimental group

Description:

The infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.

Treatment:

Behavioral: Infant obesity prevention

Financial Coaching

Experimental group

Description:

The financial coaching arm will provide parents with education on basic financial literacy topics and coaching to help parents achieve financial goals.

Treatment:

Behavioral: Financial coaching