Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT03026296
Collaborator
Western Norway University of Applied Sciences (Other)
1,022
4
1
40
255.5
6.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Life Center
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1022 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
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
Actual Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Behavioral: Healthy Life Center
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
Other Names:
  • Frisklivssentralen (Norwegian)
  • Outcome Measures

    Primary Outcome Measures

    1. physical activity [change from baseline to 3 months]

      measured by accelerometer (ActiGraph GT3X+) for seven consecutive days

    2. physical activity [change from 3 months to 15 months]

      measured by accelerometer (ActiGraph GT3X+) for seven consecutive days

    Secondary Outcome Measures

    1. Physical activity [change from baseline to 3 months]

      assessed by questionnaire

    2. Physical activity [change from 3 months to 15 months]

      assessed by questionnaire

    3. health related quality of life [change from baseline to 3 months]

      assessed by SF-36 questionnaire

    4. health related quality of life [change from 3 months to 15 months]

      assessed by SF-36 questionnaire

    5. Diet [change from baseline to 3 months]

      assessed by questionnaire

    6. Diet [change from 3 months to 15 months]

      assessed by questionnaire

    7. Tobacco use [change from baseline to 3 months]

      assessed by questionnaire

    8. Tobacco use [change from 3 months to 15 months]

      assessed by questionnaire

    9. Physical fitness [change from baseline to 3 months]

      assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill

    10. Physical fitness [change from 3 months to 15 months]

      assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill

    11. Body weight [change from baseline to 3 months]

      measured on a scale digital weight

    12. Body weight [change from 3 months to 15 months]

      measured on a scale digital weight

    13. Body Mass Index [change from baseline to 3 months]

      body height measured by a Seca altimeter

    14. Body Mass Index [change from 3 months to 15 months]

      body height measured by a Seca altimeter

    15. Waist circumference [change from baseline to 3 months]

      measured by Seca measurement tape

    16. Waist circumference [change from 3 months to 15 months]

      measured by Seca measurement tape

    17. Hip circumference [change from baseline to 3 months]

      measured by Seca measurement tape

    18. Hip circumference [change from 3 months to 15 months]

      measured by Seca measurement tape

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Frisklivssentrale Drammen (plus 9 More Communities) Buskerud County Norway
    2 Frisklivssentrale Levanger (plus 4 More Communities) Nord-Trøndelag County Norway
    3 Frisklivssentrale Bodo (plus 11 More Communities) Nordland County Norway
    4 Frisklivssentrale Laerdal (plus 6 More Communities) Sogn Og Fjordane County Norway

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • Western Norway University of Applied Sciences

    Investigators

    • Study Director: Riina Kiik, phd, Norwegian University of Science and Technology
    • Study Director: Erik Kyrkjebø, phd, Western Norway University of Applied Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT03026296
    Other Study ID Numbers:
    • 2016/546-1
    First Posted:
    Jan 20, 2017
    Last Update Posted:
    Feb 28, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norwegian University of Science and Technology
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 28, 2020