- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03026296
Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study
Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study on Changes Among Participants and Moderators for Changes Such as the Centers Capacity and Competence and the Participants Motivation
A Healthy Life Center (HLC, 'Frisklivssentrale') is a public community-based health service providing lifestyle support programs for physical activity, smoking cessation and diet, to inhabitants with increased risk for development of non-communicable diseases. HLCs intention is to reach physically inactive people who need guidance to get more physically active, and offer them a lifestyle program for three months or more.
The main aim of this study is to study whether the HLCs, organized according to the Norwegian Directorate of Health's guidelines for municipal healthy life centers, affects the participants short term (3 months) and long term (15 months) physical activity level. Also changes in diet, tobacco use, health related quality of life, physical fitness, anthropometry, self-efficacy, motivation, drug use, use of health services and work participation will be assessed. Secondary aim is to study whether there are any moderators, such as HLCs capacity, expertise, and collaboration with other services, that have significance for participants' change. Also it will be studied whether the HLCs result in larger changes in some subgroups (e.g. socioeconomic) of participants than in others.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Buskerud County
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Drammen (plus 9 More Communities), Buskerud County, 노르웨이
- Frisklivssentrale
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Nord-Trøndelag County
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Levanger (plus 4 More Communities), Nord-Trøndelag County, 노르웨이
- Frisklivssentrale
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Nordland County
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Bodo (plus 11 More Communities), Nordland County, 노르웨이
- Frisklivssentrale
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Sogn Og Fjordane County
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Laerdal (plus 6 More Communities), Sogn Og Fjordane County, 노르웨이
- Frisklivssentrale
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- about to start structural support for lifestyle change (regarding physical activity, diet and/or tobacco cessation
- referred to a Healthy Life Center (HLC) from either primary physician, from other health care services or social services, or participants seeking contact themselves without a specific referral.
Exclusion Criteria:
- having participated in an HLC the previous 6 months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Participators in HLCs
Adults with high risk of non-communicable diseases (musculoskeletal disease, obesity, physical distress) about to start a 3 months structural support for lifestyle change in a Healthy Life Center (HLC) in Norway
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Depending on what behavior participants aim to change, they get individual counselling using elements from motivational interviewing, group-based exercise twice a week, diet courses and tobacco secession courses during three months
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
physical activity
기간: change from baseline to 3 months
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measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
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change from baseline to 3 months
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physical activity
기간: change from 3 months to 15 months
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measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
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change from 3 months to 15 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Physical activity
기간: change from baseline to 3 months
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assessed by questionnaire
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change from baseline to 3 months
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Physical activity
기간: change from 3 months to 15 months
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assessed by questionnaire
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change from 3 months to 15 months
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health related quality of life
기간: change from baseline to 3 months
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assessed by SF-36 questionnaire
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change from baseline to 3 months
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health related quality of life
기간: change from 3 months to 15 months
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assessed by SF-36 questionnaire
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change from 3 months to 15 months
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Diet
기간: change from baseline to 3 months
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assessed by questionnaire
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change from baseline to 3 months
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Diet
기간: change from 3 months to 15 months
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assessed by questionnaire
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change from 3 months to 15 months
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Tobacco use
기간: change from baseline to 3 months
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assessed by questionnaire
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change from baseline to 3 months
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Tobacco use
기간: change from 3 months to 15 months
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assessed by questionnaire
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change from 3 months to 15 months
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Physical fitness
기간: change from baseline to 3 months
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assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
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change from baseline to 3 months
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Physical fitness
기간: change from 3 months to 15 months
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assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
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change from 3 months to 15 months
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Body weight
기간: change from baseline to 3 months
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measured on a scale digital weight
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change from baseline to 3 months
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Body weight
기간: change from 3 months to 15 months
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measured on a scale digital weight
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change from 3 months to 15 months
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Body Mass Index
기간: change from baseline to 3 months
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body height measured by a Seca altimeter
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change from baseline to 3 months
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Body Mass Index
기간: change from 3 months to 15 months
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body height measured by a Seca altimeter
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change from 3 months to 15 months
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Waist circumference
기간: change from baseline to 3 months
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measured by Seca measurement tape
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change from baseline to 3 months
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Waist circumference
기간: change from 3 months to 15 months
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measured by Seca measurement tape
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change from 3 months to 15 months
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Hip circumference
기간: change from baseline to 3 months
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measured by Seca measurement tape
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change from baseline to 3 months
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Hip circumference
기간: change from 3 months to 15 months
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measured by Seca measurement tape
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change from 3 months to 15 months
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공동 작업자 및 조사자
수사관
- 연구 책임자: Riina Kiik, phd, Norwegian University of Science and Technology
- 연구 책임자: Erik Kyrkjebø, phd, Western Norway University of Applied Sciences
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
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. .
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