Strong Futures: A Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
15 november 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
194
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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San Francisco, California, Förenta staterna, 94110
- Children's Health Center at San Francisco General Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Infant Obesity Prevention
The infant obesity prevention arm will provide parents with education on optimal infant feeding, sleep, and screen time practices.
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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
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Experimentell: Financial Coaching
The financial coaching arm will provide parents with education on basic financial literacy topics and coaching to help parents achieve financial goals.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Child dietary intake
Tidsram: 15-months
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Total child intake of sugar-sweetened-beverages and 100% fruit juice in ounces and total intake of fruits and vegetables in grams.
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15-months
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Child screen time
Tidsram: Child age 15-months
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Total minutes of daily screen time
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Child age 15-months
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Parent health-related quality of life
Tidsram: Child age 15-months
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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.
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Child age 15-months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Child anthropometrics
Tidsram: Child ages 6-months, 12-months, 15-months and 24-months
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World Health Organization Weight-for-length z-score
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Child ages 6-months, 12-months, 15-months and 24-months
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Parent financial stress
Tidsram: Child age 15-months
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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.
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Child age 15-months
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Child sleep
Tidsram: Child age 15-months
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Child total minutes of sleep in 24-hour period
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Child age 15-months
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Parental feeding styles
Tidsram: 15-months
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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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15-months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Amy L Beck, MD, MPH, University of California, San Francisco
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 april 2018
Primärt slutförande (Faktisk)
30 april 2021
Avslutad studie (Faktisk)
30 april 2021
Studieregistreringsdatum
Först inskickad
23 januari 2018
Först inskickad som uppfyllde QC-kriterierna
16 februari 2018
Första postat (Faktisk)
20 februari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 november 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 november 2021
Senast verifierad
1 november 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 17-24028
- 1K23HD080876-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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