Healthy Lifestyles for People With Intellectual Disabilities (HLID)
Primary Purpose
Mental Retardation, Developmental Disabilities, Intellectual Disabilities
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Lifestyles Curriculum
Sponsored by
About this trial
This is an interventional prevention trial for Mental Retardation focused on measuring 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
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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support.
Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.
Outcomes
Primary Outcome Measures
Health Promoting Lifestyles Profile II
Secondary Outcome Measures
Body Mass Index (BMI)
waist circumference
Community Integration Questionnaire
Healthy Lifestyles Knowledge Test
Starting and Continuing Healthy Behaviors
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Living Well with a Disability Evaluation
General Health Survey
Healthy Lifestyles Goal Tracking Form
Full Information
NCT ID
NCT00597948
First Posted
January 9, 2008
Last Updated
February 23, 2012
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00597948
Brief Title
Healthy Lifestyles for People With Intellectual Disabilities
Acronym
HLID
Official Title
Efficacy of a Health Intervention for People With Intellectual Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support.
Arm Title
2
Arm Type
No Intervention
Arm Description
Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Lifestyles Curriculum
Intervention Description
Three consecutive days of six hours of training comprised of instruction and participant interaction.
Primary Outcome Measure Information:
Title
Health Promoting Lifestyles Profile II
Time Frame
Pre, post, and follow-up
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Time Frame
Pre, post, and follow-up
Title
waist circumference
Time Frame
pre, post, and follow-up
Title
Community Integration Questionnaire
Time Frame
pre, post, and follow-up
Title
Healthy Lifestyles Knowledge Test
Time Frame
pre, post, and follow-up
Title
Starting and Continuing Healthy Behaviors
Time Frame
pre, post, and follow-up
Title
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Time Frame
pre, post, follow-up
Title
Living Well with a Disability Evaluation
Time Frame
pre, post, follow-up
Title
General Health Survey
Time Frame
pre, post, follow-up
Title
Healthy Lifestyles Goal Tracking Form
Time Frame
post and follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willi Horner-Johnson, Ph.D.
Organizational Affiliation
Oregon Health and Science University/Center on Community Accessibility
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Healthy Lifestyles for People With Intellectual Disabilities
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