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

Primary Purpose

Childhood Obesity, Health-Related Quality of Life

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Infant obesity prevention
Financial coaching
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Childhood Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Health Center at San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Infant Obesity Prevention

Financial Coaching

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Child screen time
Total minutes of daily screen time
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.

Secondary Outcome Measures

Child anthropometrics
World Health Organization Weight-for-length z-score
Parent financial stress
Consumer 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 sleep
Child total minutes of sleep in 24-hour period
Parental feeding styles
Study 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.

Full Information

First Posted
January 23, 2018
Last Updated
November 15, 2021
Sponsor
University of California, San Francisco
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03438721
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Health-Related Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infant Obesity Prevention
Arm Type
Experimental
Arm Description
The infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.
Arm Title
Financial Coaching
Arm Type
Experimental
Arm Description
The financial coaching arm will provide parents with education on basic financial literacy topics and coaching to help parents achieve financial goals.
Intervention Type
Behavioral
Intervention Name(s)
Infant obesity prevention
Intervention Description
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
Intervention Name(s)
Financial coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child dietary intake
Description
Total child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.
Time Frame
15-months
Title
Child screen time
Description
Total minutes of daily screen time
Time Frame
Child age 15-months
Title
Parent health-related quality of life
Description
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.
Time Frame
Child age 15-months
Secondary Outcome Measure Information:
Title
Child anthropometrics
Description
World Health Organization Weight-for-length z-score
Time Frame
Child ages 6-months, 12-months, 15-months and 24-months
Title
Parent financial stress
Description
Consumer 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.
Time Frame
Child age 15-months
Title
Child sleep
Description
Child total minutes of sleep in 24-hour period
Time Frame
Child age 15-months
Title
Parental feeding styles
Description
Study 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.
Time Frame
15-months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy L Beck, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Health Center at San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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