Strong Futures: A Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
Strong Futures: A Pilot Randomized Controlled Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
2 other identifiers
interventional
194
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
February 20, 2018
CompletedStudy Start
First participant enrolled
April 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedNovember 16, 2021
November 1, 2021
3.1 years
January 23, 2018
November 15, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Child dietary intake
Total child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.
15-months
Child screen time
Total minutes of daily screen time
Child age 15-months
Parent health-related quality of life
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 age 15-months
Secondary Outcomes (4)
Child anthropometrics
Child ages 6-months, 12-months, 15-months and 24-months
Parent financial stress
Child age 15-months
Child sleep
Child age 15-months
Parental feeding styles
15-months
Study Arms (2)
Infant Obesity Prevention
EXPERIMENTALThe infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.
Financial Coaching
EXPERIMENTALThe financial coaching arm will provide parents with education on basic financial literacy topics and coaching to help parents achieve financial goals.
Interventions
Parents will receive education on infant feeding, sleep, and screen time practices just after well-child visits in the first year of life. The education will be provided by a lay health educator. Parents will also receive text messages to reinforce the intervention content
Parents randomized to the financial coaching arm will receive basic education on financial topics including budgeting, savings, and managing debt as well as coaching on these topics just after well-child visits in the first year of life. Coaching will be provided by lay health educators trained in financial coaching. Parents will also receive text messages reinforcing the information learned.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Health Center at San Francisco General Hospital
San Francisco, California, 94110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy L Beck, MD, MPH
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2018
First Posted
February 20, 2018
Study Start
April 11, 2018
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
November 16, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share