Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Healthy Growth Abbreviated Pilot Study

4 februari 2014 uppdaterad av: Children's Hospital of Philadelphia

Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy

This is a single-group feasibility pilot trial of a peer-based, social media intervention to prevent obesity in infants.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This novel intervention, delivered to mothers primarily through private Facebook groups, will promote behavior change through peer and self-modeling photo/video activities.

In this study, we will implement an abbreviated 2-month version of the intervention with a single peer group of up to 10 mothers. We will assess the feasibility and acceptability of both the intervention and our intended outcome measures, in preparation for a randomized pilot trial of the full intervention.

Studietyp

Interventionell

Inskrivning (Faktisk)

9

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • The Children's Hospital of Philadelphia

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

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • Women age 18 years and older
  • Enrolled in Medicaid at the time of study enrollment
  • Overweight or obese (BMI >= 25, calculated using self-reported pre-pregnancy height and weight)
  • Subjects able to speak, read and write in English
  • Attend their infant's (up to 1 month old) primary care visit at a CHOP Primary Care Network site
  • Received prenatal care
  • Own a smartphone with both a data and text plan
  • Able to use their phone to obtain photographs and videos prior to enrollment

Exclusion Criteria:

  • Cannot provide consent.
  • Non-English speaking.
  • Score 10 or greater on Patient Health Questionnaire (PHQ-9) measure for clinical depression
  • Diagnosed with gestational diabetes during pregnancy with their newborn
  • Had a multiple pregnancy.
  • Premature delivery (before 37 weeks) of their newborn.
  • Have a newborn who was hospitalized in the Neonatal Intensive Care Unit (NICU) for one week or longer.

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: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Pilot Intervention Group
Mothers who are screened and determined to be eligible for this single-group pilot study will be enrolled along with their infants in the Grow Together peer group intervention.
Beteende: Grow Together peer group

Participants in this intervention will:

  • Participate in Facebook group of 6-10 peers for about 8 weeks, led by a professional group mentor.

  • Complete an intervention video activity approximately weekly:

    • 1. View educational videos addressing topics related to healthy infant growth
    • 2. Create photos/videos modeling healthy behaviors and post them to the group
    • 3. Provide and receive feedback on posts
    • 4. Be encouraged to share information with key caregivers of their child
  • Attend group party soon after enrollment, to meet peers and group leader in person.
  • Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network.
  • Have basic program information provided to pediatrician to enhance conversation during office visits.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intervention Acceptability Survey
Tidsram: Study end (approximately 2 months)
Satisfaction with the overall intervention will be assessed for mothers using a standard survey. Subjects will be asked a series of open-ended and Likert-scaled questions.
Study end (approximately 2 months)
Study population eligibility and interest
Tidsram: Study end (approximately 2 months)
  • Proportion of all mothers contacted who meet enrollment criteria
  • Proportion of mothers meeting enrollment criteria who enroll

These proportions will be calculated using study recruitment records.
Study end (approximately 2 months)
Participant engagement
Tidsram: Study end (approximately 2 months)
  • Proportion of enrolled mother-infant dyads that comply with intervention participation requirements
  • Proportion of enrolled mother-infant dyads that complete each weekly module activity
  • Proportion of enrolled mother-infant dyads that complete each study measure
  • Number and type of each participant's Facebook group interactions per week (posts, comments, "Likes")
  • Frequency, type, and content of each contact between moderator/study staff and each participant

This study process data will be obtained from the Facebook group and study records at study end.
Study end (approximately 2 months)
Week 1 Curriculum Module Acceptability Survey
Tidsram: 1 week (approximately)
Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
1 week (approximately)
Week 2 Curriculum Module Acceptability Survey
Tidsram: 2 weeks (approximately)
Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
2 weeks (approximately)
Week 3 Curriculum Module Acceptability Survey
Tidsram: 3 weeks (approximately)
Subjects will assess the Week 3 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
3 weeks (approximately)
Week 4 Curriculum Module Acceptability Survey
Tidsram: 4 weeks (approximately)
Subjects will assess the Week 4 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
4 weeks (approximately)
Week 5 Curriculum Module Acceptability Survey
Tidsram: 5 weeks (approximately)
Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
5 weeks (approximately)
Week 6 Curriculum Module Acceptability Survey
Tidsram: 6 weeks (approximately)
Subjects will assess the Week 6 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
6 weeks (approximately)
Week 7 Curriculum Module Acceptability Survey
Tidsram: 7 weeks (approximately)
Subjects will assess the Week 7 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
7 weeks (approximately)
Week 8 Curriculum Module Acceptability Survey
Tidsram: 8 weeks (approximately)
Subjects will assess the Week 8 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
8 weeks (approximately)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Infant feeding beliefs
Tidsram: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Maternal beliefs regarding infant feeding will be measured using the Infant Feeding Style Questionnaire (IFSQ), which contains 10 items measuring beliefs, coded on a 5-point scale (disagree, slightly disagree, neutral, slightly agree, agree).
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Infant feeding practices
Tidsram: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)

Maternal behaviors related to infant feeding will be measured using 10 items on the Infant Feeding Style Questionnaire (IFSQ). Behavior items are coded on a 5-point scale (never, seldom, half of the time, most of the time, always).

Also, four items from the validated Infant Feeding Practices Questionnaire (IFPQ) will be used to assess maternal feeding practices related to obesity. The IFPQ contains 20 items, with a 5-point adapted Likert response scale ranging from 0 (Never) to 4 (Always).
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Breastfeeding survey
Tidsram: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Breastfeeding intent, initiation, and duration will be assessed using a survey
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Introduction of solid foods and sugar-sweetened beverages
Tidsram: Study end (approximately 8 weeks)
Timing of initiation of solid foods and sugar sweetened beverages will be assessed using a survey.
Study end (approximately 8 weeks)
Infant sleep behaviors
Tidsram: Study end (approximately 8 weeks)
Infant sleeping and related maternal activities will be measured using the validated Brief Infant Sleep Questionnaire (BISQ). Subjects will complete the abbreviated 13-item BISQ (A-BISQ), as well as 2 additional questions from the expanded version (E-BISQ).
Study end (approximately 8 weeks)
Parenting self-efficacy
Tidsram: Study end (approximately 8 weeks)
The Karitane Parenting Confidence Scale (KPCS) is a 15-item validated scale that will be used to measure parenting self-efficacy. Questions assess the frequency of certain beliefs, skills and abilities related to successful parenting, measured using a 4-point response structure (No, hardly ever; No, not very often; Yes, some of the time; Yes, most of the time).
Study end (approximately 8 weeks)
Positive parenting behaviors
Tidsram: Study end (approximately 8 weeks)
Mothers will be assessed regarding specific parenting practices using the 10-item Infant/Toddler (IT) Home Observation for Measurement of the Environment (HOME) Inventory. Individual responses for each yes/no item are coded to 0 or 1.
Study end (approximately 8 weeks)
Maternal self-care behaviors
Tidsram: Study end (approximately 8 weeks)
Mothers will be asked 11 questions related to their self-care behaviors, including their own sleep habits, support-seeking behaviors, and taking time for themselves. These items are a combination of Likert-scaled items and simple measures of the frequency of behaviors.
Study end (approximately 8 weeks)
Maternal social support
Tidsram: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Mothers' level of social support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). This validated scale is made up of 12 items. Responses for this scale are coded from 1 to 7 (very strongly disagree, strongly disagree, mildly disagree, neutral, mildly agree, strongly agree, and very strongly agree).
Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
Maternal stress
Tidsram: Study end (approximately 8 weeks)
The Parental Stress Scale (PSS) is a validated, 18-item public domain scale measuring perceived parental stress using a 5-point Likert rating scale ('Strongly disagree' to 'strongly agree').
Study end (approximately 8 weeks)
Infant weight and growth
Tidsram: Study start (enrollment visit) and study end (approximately 8 weeks)
Infants' weight will be measured using using a calibrated digital scale and length will be measured using a standard infantometer. Measurements will be taken by a trained nurse or other trained staff member at the primary care recruitment sites, or by a member of the study staff trained in anthropometric measures.
Study start (enrollment visit) and study end (approximately 8 weeks)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Children's Hospital of Philadelphia

Utredare

  • Huvudutredare: Alexander G Fiks, MD, MSCE, Children's Hospital of Philadelphia

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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

1 september 2013

Primärt slutförande (Faktisk)

1 december 2013

Avslutad studie (Faktisk)

1 december 2013

Studieregistreringsdatum

Först inskickad

30 september 2013

Först inskickad som uppfyllde QC-kriterierna

30 oktober 2013

Första postat (Uppskatta)

6 november 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 februari 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 februari 2014

Senast verifierad

1 februari 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 12-009905

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 .

Prenumerera