- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
No Intervention: 2
Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Health Promoting Lifestyles Profile II
Time Frame: Pre, post, and follow-up
|
Pre, post, and follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body Mass Index (BMI)
Time Frame: Pre, post, and follow-up
|
Pre, post, and follow-up
|
|
waist circumference
Time Frame: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Community Integration Questionnaire
Time Frame: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Healthy Lifestyles Knowledge Test
Time Frame: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Starting and Continuing Healthy Behaviors
Time Frame: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Time Frame: pre, post, follow-up
|
pre, post, follow-up
|
|
Living Well with a Disability Evaluation
Time Frame: pre, post, follow-up
|
pre, post, follow-up
|
|
General Health Survey
Time Frame: pre, post, follow-up
|
pre, post, follow-up
|
|
Healthy Lifestyles Goal Tracking Form
Time Frame: post and follow-up
|
post and follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Willi Horner-Johnson, Ph.D., Oregon Health and Science University/Center on Community Accessibility
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- autism
- mental health
- autism spectrum disorder
- prevention
- emotional health
- cerebral palsy
- health promotion
- physical health
- mental retardation
- developmental disabilities
- behavioral health
- developmental disability
- intellectual disabilities
- intellectual disability
- spiritual health
- disease prevention
- downs syndrome
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21HD055189-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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