Clinical trial NCT00597948: Healthy Lifestyles for People With Intellectual Disabilities
Official title: Efficacy of a Health Intervention for People With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Retardation
Developmental Disabilities
Intellectual Disabilities
Keywords: mental retardation
downs syndrome
autism
autism spectrum disorder
cerebral palsy
developmental disability
developmental disabilities
intellectual disability
intellectual disabilities
health promotion
disease prevention
physical health
emotional health
behavioral health
mental health
spiritual health
prevention
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2008-01-18
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Health Promoting Lifestyles Profile II
timeFrame: Pre, post, and follow-up
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Pre, post, and follow-up
measure: waist circumference
timeFrame: pre, post, and follow-up
measure: Community Integration Questionnaire
timeFrame: pre, post, and follow-up
measure: Healthy Lifestyles Knowledge Test
timeFrame: pre, post, and follow-up
measure: Starting and Continuing Healthy Behaviors
timeFrame: pre, post, and follow-up
measure: Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
timeFrame: pre, post, follow-up
measure: Living Well with a Disability Evaluation
timeFrame: pre, post, follow-up
measure: General Health Survey
timeFrame: pre, post, follow-up
measure: Healthy Lifestyles Goal Tracking Form
timeFrame: post and follow-up
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University/Center on Community Accessibility
name: Willi Horner-Johnson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: