Families Preventing Diabetes Together
23 de agosto de 2017 atualizado por: University of Minnesota
The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age.
Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility.
Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The current study is a randomized controlled trial with 40 families. Twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through Fairview Health Services. An additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from Fairview Health Services for the parent with diabetes. Parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program.
Adult patients and their families will be recruited in two ways:
- from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
- through MyChart messages informing them about the study.
Adults between the ages of 25 and 55 years who have a diagnosis of Type 2 diabetes, who have participated in at least some diabetes education through Fairview Health Services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.
Tipo de estudo
Intervencional
Inscrição (Real)
7
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
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota, School of Nursing
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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
2 anos a 55 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Parent with Type 2 diabetes
- At least 1 child between the ages of 7-12
- Parent has completed at least some Diabetes Education through Fairview Health System
Exclusion Criteria:
- Parent with Type 2 diabetes does not speak or read in English
- No parents with Type 2 diabetes or no children ages 7-12 years
- Parent with Type 2 diabetes has not completed at least some Diabetes Education
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: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention Group
Families in the Families Preventing Diabetes Together intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months.
Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family.
All family members will be asked to attend and will be involved in all four, two-hour sessions.
The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
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Families in the intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months.
Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family.
All family members will be asked to attend and will be involved in all four, two-hour sessions.
The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
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Sem intervenção: Measurement Only
No intervention only measurements
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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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Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Prazo: up to 6 months
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Ability to successfully recruit 30- 40 families in the study will determine feasibility.
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up to 6 months
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Feasibility of the study measured via the ability to successfully measure 100% of the adults and 80% of the children in enrolled families at baseline measurements.
Prazo: up to 6 months
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Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.
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up to 6 months
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Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
Prazo: up to 6 months
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Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
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up to 6 months
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Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
Prazo: up to 6 months
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Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.
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up to 6 months
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Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
Prazo: up to 6 months
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Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
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up to 6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Child BMIz
Prazo: up to 6 months
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Objectively measured height and weight will be used to determine child BMIz values to see if the study resulted in any changes in BMIz between baseline measurements and post-intervention measurements.
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up to 6 months
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Blood glucose control in parent with Type 2 diabetes
Prazo: up to 6 months
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Change in type 2 diabetic parent's A1C values over the course of the study will be used to measure parent blood glucose control between baseline measurements and post-intervention measurements.
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up to 6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 fevereiro de 2016
Conclusão Primária (Real)
30 de junho de 2017
Conclusão do estudo (Real)
30 de junho de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
16 de fevereiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de março de 2016
Primeira postagem (Estimativa)
29 de março de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de agosto de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de agosto de 2017
Última verificação
1 de agosto de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 23085
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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