Mental RetardationHLIDNCT00597948
Healthy Lifestyles for People With Intellectual Disabilities
A study testing Healthy Lifestyles Curriculum in people with Mental Retardation and Developmental Disabilities, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Retardation, Developmental Disabilities, Intellectual Disabilities
- What is being tested?
- Healthy Lifestyles Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Efficacy of a Health Intervention for People With Intellectual Disabilities
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.
Read more
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.
- Being tested
- Healthy Lifestyles Curriculum
- 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
- Medical subject headings
- Intellectual Disability, Developmental Disabilities, Down Syndrome, Autistic Disorder, Autism Spectrum Disorder, Cerebral Palsy, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Lifestyles CurriculumBehavioural
Three consecutive days of six hours of training comprised of instruction and participant interaction.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support. Receives: Behavioral: Healthy Lifestyles Curriculum |
| 2 | No intervention | Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Promoting Lifestyles Profile II
Measured: Pre, post, and follow-up
Secondary outcomes (9)
Body Mass Index (BMI)
Measured: Pre, post, and follow-up
waist circumference
Measured: pre, post, and follow-up
Community Integration Questionnaire
Measured: pre, post, and follow-up
Healthy Lifestyles Knowledge Test
Measured: pre, post, and follow-up
Starting and Continuing Healthy Behaviors
Measured: pre, post, and follow-up
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Measured: pre, post, follow-up
Living Well with a Disability Evaluation
Measured: pre, post, follow-up
General Health Survey
Measured: pre, post, follow-up
Healthy Lifestyles Goal Tracking Form
Measured: post and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Willi Horner-Johnson, Oregon Health and Science University
- Investigators
- Willi Horner-Johnson, Ph.D., Principal investigator, Oregon Health and Science University/Center on Community Accessibility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597948
- Sponsor's protocol ID
- 1R21HD055189-01
- Other IDs
- 1R21HD055189-01
- Acronym
- HLID
- Status last verified
- Feb 2012
- First submitted
- 9 Jan 2008
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Health Intervention for People With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT00597948
- Acronym / sponsor ID
- HLID / 1R21HD055189-01
- Keywords
- mental retardation, downs syndrome, autism, autism spectrum disorder, cerebral palsy, developmental disability, developmental disabilities, intellectual disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Apr 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Healthy Lifestyles CurriculumWorkshop Group: Receives Healthy Lifestyles curriculum and subsequent support. |
| 2 | No intervention | –Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Lifestyles CurriculumThree consecutive days of six hours of training comprised of instruction and participant interaction. | Behavioural | 1 |
Primary outcome
Health Promoting Lifestyles Profile II
Time frame: Pre, post, and follow-up
9 secondary outcomes
Body Mass Index (BMI)
Time frame: Pre, post, and follow-up
waist circumference
Time frame: pre, post, and follow-up
Community Integration Questionnaire
Time frame: pre, post, and follow-up
Healthy Lifestyles Knowledge Test
Time frame: pre, post, and follow-up
Starting and Continuing Healthy Behaviors
Time frame: pre, post, and follow-up
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Time frame: pre, post, follow-up
Living Well with a Disability Evaluation
Time frame: pre, post, follow-up
General Health Survey
Time frame: pre, post, follow-up
Healthy Lifestyles Goal Tracking Form
Time frame: post and follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willi Horner-Johnson, Ph.D. principal investigator
Oregon Health and Science University/Center on Community Accessibility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyles Curriculum in people with Mental Retardation and Developmental Disabilities, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Promoting Lifestyles Profile II (time frame: Pre, post, and follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2012.