- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01977105
Healthy Growth Abbreviated Pilot Study
Abbreviated Pilot Trial of a Peer-Based Social Media Intervention to Promote Healthy Growth During Infancy
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- The Children's Hospital of Philadelphia
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Intervention Acceptability Survey
Lasso di tempo: 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
Lasso di tempo: Study end (approximately 2 months)
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These proportions will be calculated using study recruitment records. |
Study end (approximately 2 months)
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Participant engagement
Lasso di tempo: Study end (approximately 2 months)
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This study process data will be obtained from the Facebook group and study records at study end. |
Study end (approximately 2 months)
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Week 1 Curriculum Module Acceptability Survey
Lasso di tempo: 1 week (approximately)
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Subjects will assess the Week 1 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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1 week (approximately)
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Week 2 Curriculum Module Acceptability Survey
Lasso di tempo: 2 weeks (approximately)
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Subjects will assess the Week 2 curriculum activity module using a short (approximately 10-item) survey consisting of Likert-scaled and open-ended questions.
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2 weeks (approximately)
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Week 3 Curriculum Module Acceptability Survey
Lasso di tempo: 3 weeks (approximately)
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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)
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Week 4 Curriculum Module Acceptability Survey
Lasso di tempo: 4 weeks (approximately)
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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
Lasso di tempo: 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
Lasso di tempo: 6 weeks (approximately)
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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
Lasso di tempo: 7 weeks (approximately)
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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
Lasso di tempo: 8 weeks (approximately)
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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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Infant feeding beliefs
Lasso di tempo: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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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)
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Infant feeding practices
Lasso di tempo: Study start (enrollment to approximately 1 week) and study end (approximately 8 weeks)
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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)
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Breastfeeding survey
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Alexander G Fiks, MD, MSCE, Children's Hospital of Philadelphia
Pubblicazioni e link utili
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12-009905
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Grow Together peer group
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