Clinical trial NCT03438721: Strong Futures: A Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
Official title: Strong Futures: A Pilot Randomized Controlled Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Health-Related Quality of Life
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-02-20
Enrollment: 194
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Child dietary intake
timeFrame: 15-months
measure: Child screen time
timeFrame: Child age 15-months
measure: Parent health-related quality of life
timeFrame: Child age 15-months
Secondary outcomes:
measure: Child anthropometrics
timeFrame: Child ages 6-months, 12-months, 15-months and 24-months
measure: Parent financial stress
timeFrame: Child age 15-months
measure: Child sleep
timeFrame: Child age 15-months
measure: Parental feeding styles
timeFrame: 15-months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Children's Health Center at San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Amy L Beck, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: