Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Healthy Growth Abbreviated Pilot Study

4 februari 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

9

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • The Children'S Hospital Of Philadelphia

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intervention Acceptability Survey
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Infant feeding beliefs
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Children's Hospital of Philadelphia

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2013

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

30 september 2013

Eerst ingediend dat voldeed aan de QC-criteria

30 oktober 2013

Eerst geplaatst (Schatting)

6 november 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

6 februari 2014

Laatste update ingediend die voldeed aan QC-criteria

4 februari 2014

Laatst geverifieerd

1 februari 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 12-009905

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in United Kingdom

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren