- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health & Science University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
Workshop Group: Receives Healthy Lifestyles curriculum and subsequent support.
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Three consecutive days of six hours of training comprised of instruction and participant interaction.
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간섭 없음: 2
Comparison Group: Does not receive Healthy Lifestyles curriculum and subsequent support.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Health Promoting Lifestyles Profile II
기간: Pre, post, and follow-up
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Pre, post, and follow-up
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Body Mass Index (BMI)
기간: Pre, post, and follow-up
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Pre, post, and follow-up
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waist circumference
기간: pre, post, and follow-up
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pre, post, and follow-up
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Community Integration Questionnaire
기간: pre, post, and follow-up
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pre, post, and follow-up
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Healthy Lifestyles Knowledge Test
기간: pre, post, and follow-up
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pre, post, and follow-up
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Starting and Continuing Healthy Behaviors
기간: pre, post, and follow-up
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pre, post, and follow-up
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Self-Efficacy and Social Support for Activity for Persons with Intellectual Disabilities
기간: pre, post, follow-up
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pre, post, follow-up
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Living Well with a Disability Evaluation
기간: pre, post, follow-up
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pre, post, follow-up
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General Health Survey
기간: pre, post, follow-up
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pre, post, follow-up
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Healthy Lifestyles Goal Tracking Form
기간: post and follow-up
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post and follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Willi Horner-Johnson, Ph.D., Oregon Health and Science University/Center on Community Accessibility
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .