Healthy Lifestyles for People With Intellectual Disabilities

Mental Retardation Clinical Trial

— HLID  

Official title:

Efficacy of a Health Intervention for People With Intellectual Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597948
• Other study ID #: 1R21HD055189-01
• Secondary ID: 1R21HD055189-01
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: February 23, 2012
• Start date: April 2007
• Est. completion date: March 2010

Study information

• Verified date: February 2012
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Developmental Disabilities
• Intellectual Disabilities
• Intellectual Disability
• Mental Retardation

Intervention

Behavioral:
• Healthy Lifestyles Curriculum
Three consecutive days of six hours of training comprised of instruction and participant interaction.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Promoting Lifestyles Profile II		Pre, post, and follow-up	No
Secondary	Body Mass Index (BMI)		Pre, post, and follow-up	No
Secondary	waist circumference		pre, post, and follow-up	No
Secondary	Community Integration Questionnaire		pre, post, and follow-up	No
Secondary	Healthy Lifestyles Knowledge Test		pre, post, and follow-up	No
Secondary	Starting and Continuing Healthy Behaviors		pre, post, and follow-up	No
Secondary	Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities		pre, post, follow-up	No
Secondary	Living Well with a Disability Evaluation		pre, post, follow-up	No
Secondary	General Health Survey		pre, post, follow-up	No
Secondary	Healthy Lifestyles Goal Tracking Form		post and follow-up	No