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Healthy Growth Abbreviated Pilot Study

4 de fevereiro de 2014 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

9

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • The Children's Hospital of Philadelphia

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Intervention Acceptability Survey
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Infant feeding beliefs
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

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

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2013

Conclusão Primária (Real)

1 de dezembro de 2013

Conclusão do estudo (Real)

1 de dezembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

30 de setembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de outubro de 2013

Primeira postagem (Estimativa)

6 de novembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

6 de fevereiro de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de fevereiro de 2014

Última verificação

1 de fevereiro de 2014

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 12-009905

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