Healthy Lifestyles for People With Intellectual Disabilities - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00597948

Purpose

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.

Condition	Intervention
Mental Retardation Developmental Disabilities Intellectual Disabilities	Behavioral: Healthy Lifestyles Curriculum

Genetics Home Reference related topics: Down syndrome

MedlinePlus related topics: Developmental Disabilities Mental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of a Health Intervention for People With Intellectual Disabilities

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Health Promoting Lifestyles Profile II [ Time Frame: Pre, post, and follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body Mass Index (BMI) [ Time Frame: Pre, post, and follow-up ] [ Designated as safety issue: No ]
waist circumference [ Time Frame: pre, post, and follow-up ] [ Designated as safety issue: No ]
Community Integration Questionnaire [ Time Frame: pre, post, and follow-up ] [ Designated as safety issue: No ]
Healthy Lifestyles Knowledge Test [ Time Frame: pre, post, and follow-up ] [ Designated as safety issue: No ]
Starting and Continuing Healthy Behaviors [ Time Frame: pre, post, and follow-up ] [ Designated as safety issue: No ]
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities [ Time Frame: pre, post, follow-up ] [ Designated as safety issue: No ]
Living Well with a Disability Evaluation [ Time Frame: pre, post, follow-up ] [ Designated as safety issue: No ]
General Health Survey [ Time Frame: pre, post, follow-up ] [ Designated as safety issue: No ]
Healthy Lifestyles Goal Tracking Form [ Time Frame: post and follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support.	Behavioral: Healthy Lifestyles Curriculum Three consecutive days of six hours of training comprised of instruction and participant interaction.
2: No Intervention Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Living in the Portland, Oregon metropolitan area (Multnomah, Washington and Clackamas Counties) or in Vancouver (Clark County), 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597948

Contacts

Contact: Willi Horner-Johnson, Ph.D.	503-494-9273	hornerjo@ohsu.edu
Contact: Lisa M Lyman, Ph.D. (ABD)	503-494-1345	lymanl@ohsu.edu

Locations

United States, Oregon
Multnomah County	Recruiting
Portland, Oregon, United States
Washington County	Recruiting
Beaverton, Oregon, United States
Clackamas County	Recruiting
Wilsonville, Oregon, United States
United States, Washington
Clark County	Recruiting
Vancouver, Washington, United States

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Willi Horner-Johnson, Ph.D.

Oregon Health and Science University/Center on Community Accessibility

More Information

HLID Study Website--Includes study background information, activities, partners, publications, how to become a study subject or volunteer assisting with subjects, and staff contact information. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	Oregon Health and Science University/Center on Community Accessibility ( Willi Horner-Johnson/Research Assistant Professor )
Study ID Numbers:	1 R21 HD055189-01, 1 R21 HD055189-01
Study First Received:	January 9, 2008
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00597948
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Study placed in the following topic categories:

Developmental Disabilities
Paralysis
Mental Retardation
Signs and Symptoms
Cerebral Palsy
Mental Disorders

Autistic Disorder
Mental Disorders Diagnosed in Childhood
Neurologic Manifestations
Healthy
Down Syndrome
Neurobehavioral Manifestations

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009