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

NCT ID: NCT03438721

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Obesity Health-Related Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Infant Obesity Prevention

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

Group Type EXPERIMENTAL

Infant obesity prevention

Intervention Type BEHAVIORAL

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

Financial Coaching

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

Group Type EXPERIMENTAL

Financial coaching

Intervention Type BEHAVIORAL

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.

Interventions

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Infant 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

Intervention Type BEHAVIORAL

Financial coaching

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy L Beck, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Children's Health Center at San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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1K23HD080876-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-24028

Identifier Type: -

Identifier Source: org_study_id