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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.

研究概览

研究类型

介入性

注册 (实际的)

1022

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Buskerud County
      • Drammen (plus 9 More Communities)、Buskerud County、挪威
        • Frisklivssentrale
    • Nord-Trøndelag County
      • Levanger (plus 4 More Communities)、Nord-Trøndelag County、挪威
        • Frisklivssentrale
    • Nordland County
      • Bodo (plus 11 More Communities)、Nordland County、挪威
        • Frisklivssentrale
    • Sogn Og Fjordane County
      • Laerdal (plus 6 More Communities)、Sogn Og Fjordane County、挪威
        • Frisklivssentrale

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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
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
其他名称:
  • Frisklivssentralen (Norwegian)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
physical activity
大体时间:change from baseline to 3 months
measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
change from baseline to 3 months
physical activity
大体时间:change from 3 months to 15 months
measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
change from 3 months to 15 months

次要结果测量

结果测量
措施说明
大体时间
Physical activity
大体时间:change from baseline to 3 months
assessed by questionnaire
change from baseline to 3 months
Physical activity
大体时间:change from 3 months to 15 months
assessed by questionnaire
change from 3 months to 15 months
health related quality of life
大体时间:change from baseline to 3 months
assessed by SF-36 questionnaire
change from baseline to 3 months
health related quality of life
大体时间:change from 3 months to 15 months
assessed by SF-36 questionnaire
change from 3 months to 15 months
Diet
大体时间:change from baseline to 3 months
assessed by questionnaire
change from baseline to 3 months
Diet
大体时间:change from 3 months to 15 months
assessed by questionnaire
change from 3 months to 15 months
Tobacco use
大体时间:change from baseline to 3 months
assessed by questionnaire
change from baseline to 3 months
Tobacco use
大体时间:change from 3 months to 15 months
assessed by questionnaire
change from 3 months to 15 months
Physical fitness
大体时间:change from baseline to 3 months
assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
change from baseline to 3 months
Physical fitness
大体时间:change from 3 months to 15 months
assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
change from 3 months to 15 months
Body weight
大体时间:change from baseline to 3 months
measured on a scale digital weight
change from baseline to 3 months
Body weight
大体时间:change from 3 months to 15 months
measured on a scale digital weight
change from 3 months to 15 months
Body Mass Index
大体时间:change from baseline to 3 months
body height measured by a Seca altimeter
change from baseline to 3 months
Body Mass Index
大体时间:change from 3 months to 15 months
body height measured by a Seca altimeter
change from 3 months to 15 months
Waist circumference
大体时间:change from baseline to 3 months
measured by Seca measurement tape
change from baseline to 3 months
Waist circumference
大体时间:change from 3 months to 15 months
measured by Seca measurement tape
change from 3 months to 15 months
Hip circumference
大体时间:change from baseline to 3 months
measured by Seca measurement tape
change from baseline to 3 months
Hip circumference
大体时间:change from 3 months to 15 months
measured by Seca measurement tape
change from 3 months to 15 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Riina Kiik, phd、Norwegian University of Science and Technology
  • 研究主任:Erik Kyrkjebø, phd、Western Norway University of Applied Sciences

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年8月1日

初级完成 (实际的)

2019年12月1日

研究完成 (实际的)

2019年12月1日

研究注册日期

首次提交

2017年1月17日

首先提交符合 QC 标准的

2017年1月17日

首次发布 (估计)

2017年1月20日

研究记录更新

最后更新发布 (实际的)

2020年2月28日

上次提交的符合 QC 标准的更新

2020年2月26日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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