Supporting Baby Behavior Through Pediatric Offices
25 september 2018 uppdaterad av: University of California, Davis
The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The primary objective of this project is to evaluate the impact on infant growth and infant-feeding practices of a low-cost series of video trainings and tools targeted to medical staff and designed to support ongoing Baby Behavior education of WIC participants.
The intervention, currently used in all California WIC agencies, teaches caregivers to recognize and understand healthy infant behaviors such as the range of infant cues and common patterns for sleep and crying.
This project will also evaluate the acceptance, knowledge transfer, and use of the tools by health care providers and medical staff.
It is expected that trained staff will be prepared to share Baby Behavior messages with their patients and that the information will be delivered quickly and easily during well-baby visits.
Studietyp
Interventionell
Inskrivning (Faktisk)
423
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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Davis, California, Förenta staterna, 95616
- University of California, Davis
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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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Will attend a participating pediatric clinic for her well-baby visits
- Primiparous, singleton pregnancy
- Currently enrolled in WIC
- At least 18 years of age
- Speaks and reads English or Spanish
- Has a telephone and access to the internet
- Plans to stay in the area for 6 months after birth of infant
- Abstained from smoking during pregnancy
Exclusion criteria:
- Gave birth before 37 weeks gestation
- She and/or her infant has health condition(s) or known health risks that contraindicate breastfeeding
- She and/or her infant has health condition(s) or known health risks that impact infant growth and development
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Baby Behavior
The intervention is comprised of 2 components: HCP and medical staff training and participant education. The trainings will be video-based and aim to build providers' knowledge and skills to support parents' recognition and understanding of common healthy infant behaviors that may be misinterpreted by parents. The intervention does not include any specific recommendations for infant feeding, nor does it include any information related to the assessment, diagnosis or treatment for any medical condition. After completion of the intervention trainings, health care providers and medical staff will be asked to use what they learned with the mothers of infants in their care. Short handouts for mothers will be provided as tools to reinforce the verbal education. All educational materials will be focused only on supporting parents' abilities to recognize and understand common, healthy infant behaviors. |
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Inget ingripande: Control
The control arm will continue with standard well-baby visit practices during the intervention period and will be offered the option to complete the Baby Behavior online trainings for continuing education credits.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Weight-for-length growth trajectory
Tidsram: Up to 6 months postpartum
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Weight-for-length Z scores calculated using the WHO Multicenter Growth Standards
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Up to 6 months postpartum
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Infant feeding practices
Tidsram: 1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
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Breastfeeding duration and exclusivity, introduction of non-breast milk foods and fluids, use of sugary beverages, and intake of formula and select complementary foods
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1 week, 2 weeks, 2 months, 4 months, and 6 months postpartum
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Maternal depressive symptoms
Tidsram: 2 weeks and 6 months postpartum
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Edinburgh Postnatal Depression Scale
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2 weeks and 6 months postpartum
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Maternal self-efficacy
Tidsram: 1 week, 2 months, and 6 months postpartum
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Perceived Maternal Parenting Self-Efficacy
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1 week, 2 months, and 6 months postpartum
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Maternal perceived stress
Tidsram: 1 week, 2 months, and 6 months postpartum
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Perceived Stress Scale Short-Form
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1 week, 2 months, and 6 months postpartum
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Infant sleep patterns
Tidsram: 2 months and 6 months postpartum
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Brief Infant Sleep Questionnaire
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2 months and 6 months postpartum
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Infant development
Tidsram: 2 months, 4 months, and 6 months postpartum
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Ages and Stages Questionnaire
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2 months, 4 months, and 6 months postpartum
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Infant eating behavior
Tidsram: 4 months postpartum
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Baby Eating Behavior Questionnaire
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4 months postpartum
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Jane Heinig, PhD, University of California, Davis
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)
1 mars 2015
Primärt slutförande (Faktisk)
7 december 2016
Avslutad studie (Faktisk)
16 februari 2017
Studieregistreringsdatum
Först inskickad
6 maj 2015
Först inskickad som uppfyllde QC-kriterierna
6 maj 2015
Första postat (Uppskatta)
8 maj 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 september 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 september 2018
Senast verifierad
1 september 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 687861
- WIC NEI-12-TX (Annan identifierare: UC Davis)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .