- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00597948
Healthy Lifestyles for People With Intellectual Disabilities (HLID)
Efficacy of a Health Intervention for People With Intellectual Disabilities
Relatively few health promotion and disease prevention programs have included or targeted people with disabilities, and even fewer have focused on individuals with intellectual disabilities.
The long-term objectives of the Healthy Lifestyles for People with Intellectual Disabilities Study (HLID) are to increase the health of persons with intellectual disabilities by establishing the efficacy of a health promotion program and promoting its adoption. The HLID Study is based in the Center on Community Accessibility (CCA) at Oregon Health & Science University. The mission of CCA is to increase the health and health-related quality of life of persons with disabilities.
A pilot study conducted by CCA has established the effectiveness of the Healthy Lifestyles (HL) intervention among a cross-disability population in increasing health behavior adoption. The specific aim of the HLID Study is to test the efficacy of the HL program specifically with adults with intellectual disabilities.
The HLID Study uses a randomized control study design. The HL intervention will be administered to 75 adults and will compare results to those of an additional 75 adults who receive no intervention. Measurement will include anthropometric assessments to measure impacts on overweight and obesity, as well as self-report measures of healthy behaviors, health status, health care utilization, and secondary conditions. Results will be shared with research participants, presented through professional conferences and newsletters, and published in peer-reviewed journals with the assistance of community partners.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Living in Oregon or Southwest Washington
- Ages 18-65 years
- Have mild or moderate mental retardation/developmental disability/intellectual disability as defined by Oregon or Washington state (depending on place of residence) developmental disability service delivery system
- Eligible in Oregon or Washington (depending on place of residence) to receive services for people with mental retardation/developmental/intellectual disability
- Living in the community (i.e., group home, with family/friends, on own with or without support)
- Participant defined health status of excellent, good, or fair
- Participant expressed interest in participation in study
- Participant expressed willingness to be assigned to either Workshop or Control study group
Plano de estudo
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 |
|---|---|
|
Experimental: 1
Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support.
|
Three consecutive days of six hours of training comprised of instruction and participant interaction.
|
|
Sem intervenção: 2
Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Health Promoting Lifestyles Profile II
Prazo: Pre, post, and follow-up
|
Pre, post, and follow-up
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Body Mass Index (BMI)
Prazo: Pre, post, and follow-up
|
Pre, post, and follow-up
|
|
waist circumference
Prazo: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Community Integration Questionnaire
Prazo: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Healthy Lifestyles Knowledge Test
Prazo: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Starting and Continuing Healthy Behaviors
Prazo: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Prazo: pre, post, follow-up
|
pre, post, follow-up
|
|
Living Well with a Disability Evaluation
Prazo: pre, post, follow-up
|
pre, post, follow-up
|
|
General Health Survey
Prazo: pre, post, follow-up
|
pre, post, follow-up
|
|
Healthy Lifestyles Goal Tracking Form
Prazo: post and follow-up
|
post and follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Willi Horner-Johnson, Ph.D., Oregon Health and Science University/Center on Community Accessibility
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (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
- autismo
- saúde mental
- transtorno do espectro autista
- prevenção
- saúde emocional
- paralisia cerebral
- promoção de saúde
- saúde física
- retardo mental
- deficiências de desenvolvimento
- saúde comportamental
- deficiência de desenvolvimento
- dificuldades intelectuais
- deficiência intelectual
- saúde espiritual
- prevenção de doença
- downs syndrome
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R21HD055189-01 (Concessão/Contrato do NIH dos EUA)
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 .