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- Ensaio Clínico NCT03080064
Health Coach Intervention Pilot Study (AHA)
Supporting Healthful Lifestyles During Pregnancy: A Health Coach Intervention Pilot Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
<Health Coach Intervention > The investigators connected participants at enrollment (median gestation of 12.5 weeks, IQR: 11-15) with a trained health coach who called participants every 2-3 weeks until 36 weeks of gestation. During these phone calls, health coaches helped participants adopt and maintain new healthful lifestyle behaviors that were evidence-based, simple, and easy to track. Goals aimed to promote appropriate gestational weight gain and covered several domains including diet, physical activity, screen time, and sleep.
During the first call, health coaches invited participants to prioritize these goals according to their level of self-efficacy, readiness to change, preferences, and values. Throughout the intervention, health coaches used principles of motivational interviewing that relied on a patient-centered approach to enhance readiness to change by exploring ambivalence and resistance to change. In addition to setting personal goals, health coaches also presented optimal goals for ideal cardiovascular health.
During follow-up calls, health coaches monitored progress and helped adjust goals when necessary (e.g. too many goals, or the goal was too ambitious). Health coaches also addressed barriers and potential solutions with participants, and helped them target higher goal settings or select novel goals when participants attained them. Health coaches sent emails or text messages depending on participant preferences to check-in about progress toward goals or clinical appointments between calls. Research staff (including an MD) met weekly with health coaches to review their conversations with participants, and to address any medical issues to ensure that it would be reported to the primary care provider obstetric team if appropriate.
<Study Design and Sample> Participants completed baseline (N=30) and follow-up (N=26) surveys at the end of the intervention as well as follow-up phone interviews (N=18). Surveys collected information on demographics, attitudes related to weight status and pregnancy, opinions about the intervention, and included food frequency questions . Interviews followed a guide of open-ended questions to determine insights on what helped achieve goals, motivation, opinions of the health coach intervention, and areas for improvement. One study staff member, who has experience with qualitative data collection, conducted all of the individual interviews. This study was approved by the Harvard Pilgrim Health Care Human Studies Committee.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Harvard Pilgrim Health Care Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- pregnant (less than 16 weeks of gestation),
- overweight or obese (pre-pregnancy BMI≥25 kg/m2),
- 18 years of age or older,
- English speaking,
- planned to remain at the same obstetrics clinic for the duration of their pregnancies.
Plano de estudo
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 |
|---|---|
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Experimental: Health Coach Intervention
The investigators connected participants at enrollment (median gestation of 12.5 weeks, IQR: 11-15) with a trained health coach who called participants every 2-3 weeks until 36 weeks of gestation.
During these phone calls, health coaches helped participants adopt and maintain new healthful lifestyle behaviors that were evidence-based, simple, and easy to track.
Goals aimed to promote appropriate gestational weight gain and covered several domains including diet, physical activity, screen time, and sleep.
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Please see arm description.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Satisfaction with the health coach intervention as assessed by surveys
Prazo: From enrollment until the end of the intervention at 36 weeks of gestation.
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The investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women using baseline and follow-up surveys.
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From enrollment until the end of the intervention at 36 weeks of gestation.
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Satisfaction with the health coach intervention as assessed by phone interviews
Prazo: From enrollment until the end of the intervention at 36 weeks of gestation.
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Using an interview guide, the investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women.
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From enrollment until the end of the intervention at 36 weeks of gestation.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marie-France Hivert, MD, MMSc, Harvard Pilgrim Health Care Institute
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- PH000523C
- 14CRP20490354 (Número de outro subsídio/financiamento: American Heart Association)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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