- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01977105
Healthy Growth Abbreviated Pilot Study
Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- The Children's Hospital of Philadelphia
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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Participants in this intervention will:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Intervention Acceptability Survey
Tidsramme: Study end (approximately 2 months)
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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.
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Study end (approximately 2 months)
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Study population eligibility and interest
Tidsramme: Study end (approximately 2 months)
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These proportions will be calculated using study recruitment records. |
Study end (approximately 2 months)
|
Participant engagement
Tidsramme: Study end (approximately 2 months)
|
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.
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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.
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4 weeks (approximately)
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Week 5 Curriculum Module Acceptability Survey
Tidsramme: 5 weeks (approximately)
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Subjects will assess the Week 5 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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5 weeks (approximately)
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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.
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6 weeks (approximately)
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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.
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7 weeks (approximately)
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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.
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8 weeks (approximately)
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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).
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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)
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Breastfeeding intent, initiation, and duration will be assessed using a survey
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Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Introduction of solid foods and sugar-sweetened beverages
Tidsramme: Study end (approximately 8 weeks)
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Timing of initiation of solid foods and sugar sweetened beverages will be assessed using a survey.
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Study end (approximately 8 weeks)
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Infant sleep behaviors
Tidsramme: Study end (approximately 8 weeks)
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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).
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Study end (approximately 8 weeks)
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Parenting self-efficacy
Tidsramme: Study end (approximately 8 weeks)
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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).
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Study end (approximately 8 weeks)
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Positive parenting behaviors
Tidsramme: Study end (approximately 8 weeks)
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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.
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Study end (approximately 8 weeks)
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Maternal self-care behaviors
Tidsramme: Study end (approximately 8 weeks)
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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.
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Study end (approximately 8 weeks)
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Maternal social support
Tidsramme: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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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).
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Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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Maternal stress
Tidsramme: Study end (approximately 8 weeks)
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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').
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Study end (approximately 8 weeks)
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Infant weight and growth
Tidsramme: Study start (enrollment visit) and study end (approximately 8 weeks)
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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.
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Study start (enrollment visit) and study end (approximately 8 weeks)
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Alexander G Fiks, MD, MSCE, Children's Hospital of Philadelphia
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 12-009905
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