- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00597948
Healthy Lifestyles for People With Intellectual Disabilities (HLID)
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.
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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Oregon
-
Portland, Oregon, Förenta staterna, 97239
- Oregon Health & Science University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support.
|
Three consecutive days of six hours of training comprised of instruction and participant interaction.
|
Inget ingripande: 2
Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Health Promoting Lifestyles Profile II
Tidsram: Pre, post, and follow-up
|
Pre, post, and follow-up
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Body Mass Index (BMI)
Tidsram: Pre, post, and follow-up
|
Pre, post, and follow-up
|
waist circumference
Tidsram: pre, post, and follow-up
|
pre, post, and follow-up
|
Community Integration Questionnaire
Tidsram: pre, post, and follow-up
|
pre, post, and follow-up
|
Healthy Lifestyles Knowledge Test
Tidsram: pre, post, and follow-up
|
pre, post, and follow-up
|
Starting and Continuing Healthy Behaviors
Tidsram: pre, post, and follow-up
|
pre, post, and follow-up
|
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Tidsram: pre, post, follow-up
|
pre, post, follow-up
|
Living Well with a Disability Evaluation
Tidsram: pre, post, follow-up
|
pre, post, follow-up
|
General Health Survey
Tidsram: pre, post, follow-up
|
pre, post, follow-up
|
Healthy Lifestyles Goal Tracking Form
Tidsram: post and follow-up
|
post and follow-up
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Willi Horner-Johnson, Ph.D., Oregon Health and Science University/Center on Community Accessibility
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- autism
- mental hälsa
- autismspektrumstörning
- förebyggande
- känslomässig hälsa
- cerebral pares
- hälsofrämjande
- fysisk hälsa
- utvecklingsstörd
- utvecklingsstörning
- beteendehälsa
- utvecklingsstörning
- Intellektuella funktionshinder
- intellektuell funktionsnedsättning
- andlig hälsa
- sjukdomsprevention
- downs syndrome
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1R21HD055189-01 (U.S.S. NIH-anslag/kontrakt)
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