- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Oregon
-
Portland, Oregon, Estados Unidos, 97239
- Oregon Health & Science University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
Sin intervención: 2
Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Health Promoting Lifestyles Profile II
Periodo de tiempo: Pre, post, and follow-up
|
Pre, post, and follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Body Mass Index (BMI)
Periodo de tiempo: Pre, post, and follow-up
|
Pre, post, and follow-up
|
|
waist circumference
Periodo de tiempo: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Community Integration Questionnaire
Periodo de tiempo: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Healthy Lifestyles Knowledge Test
Periodo de tiempo: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Starting and Continuing Healthy Behaviors
Periodo de tiempo: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Periodo de tiempo: pre, post, follow-up
|
pre, post, follow-up
|
|
Living Well with a Disability Evaluation
Periodo de tiempo: pre, post, follow-up
|
pre, post, follow-up
|
|
General Health Survey
Periodo de tiempo: pre, post, follow-up
|
pre, post, follow-up
|
|
Healthy Lifestyles Goal Tracking Form
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- autismo
- salud mental
- desorden del espectro autista
- prevención
- salud emocional
- parálisis cerebral
- promoción de la salud
- salud física
- retraso mental
- discapacidades del desarrollo
- salud del comportamiento
- La discapacidad del desarrollo
- discapacidades intelectuales
- Discapacidad intelectual
- salud espiritual
- la prevención de enfermedades
- downs syndrome
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R21HD055189-01 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .