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

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ClinicalTrials.gov Identifier: NCT03438721
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Amy Beck, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Health-Related Quality of Life Behavioral: Infant obesity prevention Behavioral: Financial coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Strong Futures: A Pilot Randomized Controlled Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Infant Obesity Prevention
The infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.
Behavioral: 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

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




Primary Outcome Measures :
  1. Child dietary intake [ Time Frame: 15-months ]
    Total child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.

  2. Child screen time [ Time Frame: Child age 15-months ]
    Total minutes of daily screen time

  3. Parent health-related quality of life [ Time Frame: Child age 15-months ]
    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 :
  1. Child anthropometrics [ Time Frame: Child ages 6-months, 12-months, 15-months and 24-months ]
    World Health Organization Weight-for-length z-score

  2. Parent financial stress [ Time Frame: Child age 15-months ]
    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.

  3. Child sleep [ Time Frame: Child age 15-months ]
    Child total minutes of sleep in 24-hour period

  4. Parental feeding styles [ Time Frame: 15-months ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438721


Contacts
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Contact: Amy L Beck, MD MPH (415) 476-3368 amy.beck@ucsf.edu

Locations
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United States, California
Children's Health Center at San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Amy L Beck, MD MPH         
Sponsors and Collaborators
University of California, San Francisco
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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Responsible Party: Amy Beck, Assistant Professor of Pediatrics, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03438721     History of Changes
Other Study ID Numbers: 17-24028
1K23HD080876-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms