- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1
Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support.
|
Three consecutive days of six hours of training comprised of instruction and participant interaction.
|
|
Ingen inngripen: 2
Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Health Promoting Lifestyles Profile II
Tidsramme: Pre, post, and follow-up
|
Pre, post, and follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Body Mass Index (BMI)
Tidsramme: Pre, post, and follow-up
|
Pre, post, and follow-up
|
|
waist circumference
Tidsramme: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Community Integration Questionnaire
Tidsramme: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Healthy Lifestyles Knowledge Test
Tidsramme: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Starting and Continuing Healthy Behaviors
Tidsramme: pre, post, and follow-up
|
pre, post, and follow-up
|
|
Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
Tidsramme: pre, post, follow-up
|
pre, post, follow-up
|
|
Living Well with a Disability Evaluation
Tidsramme: pre, post, follow-up
|
pre, post, follow-up
|
|
General Health Survey
Tidsramme: pre, post, follow-up
|
pre, post, follow-up
|
|
Healthy Lifestyles Goal Tracking Form
Tidsramme: post and follow-up
|
post and follow-up
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Willi Horner-Johnson, Ph.D., Oregon Health and Science University/Center on Community Accessibility
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- autisme
- mental Helse
- autismespekterforstyrrelse
- forebygging
- emosjonell helse
- cerebral parese
- helsefremmende
- fysisk helse
- mental retardasjon
- utviklingshemming
- atferdshelse
- utviklingshemming
- intellektuelle funksjonshemninger
- intellektuell funksjonshemming
- åndelig helse
- sykdomsforebygging
- downs syndrome
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R21HD055189-01 (U.S. NIH-stipend/kontrakt)
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