NCT00597948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 27, 2012

Status Verified

February 1, 2012

Enrollment Period

2.8 years

First QC Date

January 9, 2008

Last Update Submit

February 23, 2012

Conditions

Keywords

mental retardationdowns syndromeautismautism spectrum disordercerebral palsydevelopmental disabilitydevelopmental disabilitiesintellectual disabilityintellectual disabilitieshealth promotiondisease preventionphysical healthemotional healthbehavioral healthmental healthspiritual healthprevention

Outcome Measures

Primary Outcomes (1)

  • Health Promoting Lifestyles Profile II

    Pre, post, and follow-up

Secondary Outcomes (9)

  • Body Mass Index (BMI)

    Pre, post, and follow-up

  • waist circumference

    pre, post, and follow-up

  • Community Integration Questionnaire

    pre, post, and follow-up

  • Healthy Lifestyles Knowledge Test

    pre, post, and follow-up

  • Starting and Continuing Healthy Behaviors

    pre, post, and follow-up

  • +4 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support.

Behavioral: Healthy Lifestyles Curriculum

2

NO INTERVENTION

Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.

Interventions

Three consecutive days of six hours of training comprised of instruction and participant interaction.

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Intellectual DisabilityDevelopmental DisabilitiesDown SyndromeAutistic DisorderAutism Spectrum DisorderCerebral PalsyPsychological Well-Being

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornChild Development Disorders, PervasiveBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesPersonal SatisfactionBehavior

Study Officials

  • Willi Horner-Johnson, Ph.D.

    Oregon Health and Science University/Center on Community Accessibility

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

April 1, 2007

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

February 27, 2012

Record last verified: 2012-02

Locations