Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia (DE-PLAN-CAT)
Diabetes in Europe - Prevention Using Lifestyle, Physical Activity and Nutritional Intervention in Catalonia(DE-PLAN-CAT).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Diabetes is one of the most devastating diseases because of its big impact on public health. Taking fast decisions and vigorous actions like the ones proposed by this European project (DE-PLAN) adapted to the Spanish and the Catalan actual situation (coordinated project FIS and DE-PLAN-CAT respectively) can avert it.
We consider a two-step strategy whose main objective is the primary prevention of diabetes in the European population at highest-risk. At the first stage, a non-invasive screening program will evaluate the risk of diabetes by means of a validated questionnaire (FINDRISK survey). It will be distributed at random to 2000 outpatients of public health service in Catalonia. It involves twenty primary care facilities that refer to five different centers where research scientists (executive committee) are coordinated by the head of these centers (coordinating committee) and are organised (managing committee) according to the European regulation (central committee). One third of the subjects are expected to present high-risk criteria. They will choose one out of three possible interventions to modify their lifestyle (informative approach, one-to-one or group training). For the last options, a 6-hour training program will be carried out in four sessions lasting 1,5 hours each. The trainers in charge will periodically stimulate the participants motivation.
The study will go on in the routine health care and it will assess diabetes incidence according to the economic estimation of the cost-effectiveness relation of the adopted measures involved in health care policies and prevention programs.
This project aims to evidence how the already known efficacy of these types of programs can apply to its effectiveness (on large populations) and its cost-effectiveness (in socio-economic terms). Other objectives are 1) to create one bigger database of diabetes and cardiovascular disease risks and 2) to contribute to the edition of a European manual on type 2 diabetes prevention.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Barcelona, Espanha
- IDIAP Jordi Gol
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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:
- High risk (> or equal 14 points in FINDRISC score)
- PTOG with IFG/ITG or both
- Able to sign informed consent
Exclusion Criteria:
- Type 2 diabetes in screening
- Low risk (< 14 points in FINDRISC)
- Terminal diseases
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Lifestyle counseling
Complete lifestyle counseling including
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INDIVIDUAL INTERVENTIONS They were programmed to come the nurse office three times (1 ½ -2 hours each).
Individual intervention efforts outside of weight control and other intervention groups were also supported.
In fact, this kind of intervention was similar to the group intervention but one-by-one participant subject.
GROUP INTERVENTIONS Six-hour educational programme structured in 2 to 4 sessions with 5 to 15 participants.
We called all participants to remind them their group schedule (date/hour).
The methods used in the group intervention were variable depending on the experience of the manager, group member' s needs and skills available (empowerment).
Results were based on motivation, support from the other members, peer support and positive feedback.
Outros nomes:
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Sem intervenção: Usual health care
Usual health care, including self-administered information by leaflets
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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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Incident cases of type 2 diabetes
Prazo: 4 years
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New cases of type 2 diabetes in subjects with high risk during the duration of the study
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4 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluation of quality of life
Prazo: 4 years
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Quality of life in the 15-D questionnaire
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4 years
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Cost-effectiveness
Prazo: 4 years
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Evaluation of cost-effectiveness of the efforts to prevent one case of diabetes
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4 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Bernardo Costa, MD PhD, Catalan Institute of Health
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P05/38
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