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Healthy Growth Abbreviated Pilot Study

4. februar 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • The Children's Hospital of Philadelphia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intervention Acceptability Survey
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Infant feeding beliefs
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2013

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

30. september 2013

Først indsendt, der opfyldte QC-kriterier

30. oktober 2013

Først opslået (Skøn)

6. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 12-009905

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fedme hos børn

Kliniske forsøg med Grow Together peer group

Abonner