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

15 november 2021 bijgewerkt door: University of California, San Francisco

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

194

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • California
      • San Francisco, California, Verenigde Staten, 94110
        • Children's Health Center at San Francisco General Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Infant Obesity Prevention
The infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.
Gedragsmatig: 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
Experimenteel: Financial Coaching
The financial coaching arm will provide parents with education on basic financial literacy topics and coaching to help parents achieve financial goals.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Child dietary intake
Tijdsspanne: 15-months
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
Tijdsspanne: Child age 15-months
Total minutes of daily screen time
Child age 15-months
Parent health-related quality of life
Tijdsspanne: 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.
Child age 15-months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Child anthropometrics
Tijdsspanne: Child ages 6-months, 12-months, 15-months and 24-months
World Health Organization Weight-for-length z-score
Child ages 6-months, 12-months, 15-months and 24-months
Parent financial stress
Tijdsspanne: 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.
Child age 15-months
Child sleep
Tijdsspanne: Child age 15-months
Child total minutes of sleep in 24-hour period
Child age 15-months
Parental feeding styles
Tijdsspanne: 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.
15-months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, San Francisco

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Amy L Beck, MD, MPH, University of California, San Francisco

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 april 2018

Primaire voltooiing (Werkelijk)

30 april 2021

Studie voltooiing (Werkelijk)

30 april 2021

Studieregistratiedata

Eerst ingediend

23 januari 2018

Eerst ingediend dat voldeed aan de QC-criteria

16 februari 2018

Eerst geplaatst (Werkelijk)

20 februari 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 november 2021

Laatste update ingediend die voldeed aan QC-criteria

15 november 2021

Laatst geverifieerd

1 november 2021

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 17-24028
  • 1K23HD080876-01A1 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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