Strong Futures: A Trial of Two Primary Care Based Interventions to Promote Optimal Health in Latino Infants and Toddlers
15 novembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
194
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94110
- Children's Health Center at San Francisco General Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Child dietary intake
Délai: 15-months
|
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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Child anthropometrics
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Amy L Beck, MD, MPH, University of California, San Francisco
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 avril 2018
Achèvement primaire (Réel)
30 avril 2021
Achèvement de l'étude (Réel)
30 avril 2021
Dates d'inscription aux études
Première soumission
23 janvier 2018
Première soumission répondant aux critères de contrôle qualité
16 février 2018
Première publication (Réel)
20 février 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 novembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 novembre 2021
Dernière vérification
1 novembre 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 17-24028
- 1K23HD080876-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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