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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03438721
Enrollment
194
Registered
2018-02-20
Start date
2018-04-11
Completion date
2021-04-30
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity, Health-Related Quality of Life

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.

Interventions

BEHAVIORALInfant obesity prevention

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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Child dietary intake15-monthsTotal child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.
Child screen timeChild age 15-monthsTotal minutes of daily screen time
Parent health-related quality of lifeChild age 15-monthsAssessed 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.

Secondary

MeasureTime frameDescription
Child anthropometricsChild ages 6-months, 12-months, 15-months and 24-monthsWorld Health Organization Weight-for-length z-score
Parental feeding styles15-monthsStudy investigators will assess responsive, pressuring and indulgent feeding styles using the responsive satiety, pressuring finishing, pressuring soothing, and indulgence permissive sub-scales of the Infant Feeding Styles Questionnaire. These sub-scales assess both behaviors and beliefs relevant to the construct. Scores range from 1-5 with higher scores indicating greater use of that feeding style.
Parent financial stressChild age 15-monthsConsumer Financial Protection Bureau Financial Well-Being Scale. The Consumer Financial Protection Bureau Financial Well Being Questionnaire (Short Form, CFPB Financial Well Being Questionnaire SF) is a five item scale measuring individual financial well-being. The CFPB Financial Well Being Questionnaire has a range of 0-20 raw score, based on a 5-point Likert scale for each item, with one item (item 4) reverse coded and summed with responses for the remaining items to arrive at the raw score. The raw score is converted to a reference financial well-being score.Higher scores indicate greater financial well-being.
Child sleepChild age 15-monthsChild total minutes of sleep in 24-hour period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026