Healthy Lifestyles for People With Intellectual Disabilities (HLID)

• ClinicalTrials.gov Identifier: NCT00597948
• Recruitment Status: Completed
• First Posted: January 18, 2008
• Last Update Posted: February 27, 2012
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Willi Horner-Johnson, Oregon Health and Science University

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.

Condition or disease	Intervention/treatment	Phase
Mental Retardation; Developmental Disabilities; Intellectual Disabilities	Behavioral: Healthy Lifestyles Curriculum	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Efficacy of a Health Intervention for People With Intellectual Disabilities
• Study Start Date: April 2007
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 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.
No Intervention: 2; Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.

Outcome Measures

Primary Outcome Measures :

1. Health Promoting Lifestyles Profile II [ Time Frame: Pre, post, and follow-up ]

Secondary Outcome Measures :

1. Body Mass Index (BMI) [ Time Frame: Pre, post, and follow-up ]
2. waist circumference [ Time Frame: pre, post, and follow-up ]
3. Community Integration Questionnaire [ Time Frame: pre, post, and follow-up ]
4. Healthy Lifestyles Knowledge Test [ Time Frame: pre, post, and follow-up ]
5. Starting and Continuing Healthy Behaviors [ Time Frame: pre, post, and follow-up ]
6. Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities [ Time Frame: pre, post, follow-up ]
7. Living Well with a Disability Evaluation [ Time Frame: pre, post, follow-up ]
8. General Health Survey [ Time Frame: pre, post, follow-up ]
9. Healthy Lifestyles Goal Tracking Form [ Time Frame: post and follow-up ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

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

• Responsible Party: Willi Horner-Johnson, Research Assistant Professor, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00597948
• Other Study ID Numbers: 1R21HD055189-01 ( U.S. NIH Grant/Contract ); 1R21HD055189-01 ( U.S. NIH Grant/Contract )
• First Posted: January 18, 2008
• Last Update Posted: February 27, 2012
• Last Verified: February 2012

Keywords provided by Willi Horner-Johnson, Oregon Health and Science University:

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

Additional relevant MeSH terms:

Intellectual Disability; Developmental Disabilities; Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Mental Disorders