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

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ClinicalTrials.gov Identifier: NCT03026296
Recruitment Status : Completed
First Posted : January 20, 2017
Last Update Posted : February 28, 2020
Sponsor:
Collaborator:
Western Norway University of Applied Sciences
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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
Musculoskeletal Disease Obesity Psychological Disorder Behavioral: Healthy Life Center Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: Frisklivssentralen (Norwegian)




Primary Outcome Measures :
  1. physical activity [ Time Frame: change from baseline to 3 months ]
    measured by accelerometer (ActiGraph GT3X+) for seven consecutive days

  2. physical activity [ Time Frame: change from 3 months to 15 months ]
    measured by accelerometer (ActiGraph GT3X+) for seven consecutive days


Secondary Outcome Measures :
  1. Physical activity [ Time Frame: change from baseline to 3 months ]
    assessed by questionnaire

  2. Physical activity [ Time Frame: change from 3 months to 15 months ]
    assessed by questionnaire

  3. health related quality of life [ Time Frame: change from baseline to 3 months ]
    assessed by SF-36 questionnaire

  4. health related quality of life [ Time Frame: change from 3 months to 15 months ]
    assessed by SF-36 questionnaire

  5. Diet [ Time Frame: change from baseline to 3 months ]
    assessed by questionnaire

  6. Diet [ Time Frame: change from 3 months to 15 months ]
    assessed by questionnaire

  7. Tobacco use [ Time Frame: change from baseline to 3 months ]
    assessed by questionnaire

  8. Tobacco use [ Time Frame: change from 3 months to 15 months ]
    assessed by questionnaire

  9. Physical fitness [ Time Frame: change from baseline to 3 months ]
    assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill

  10. Physical fitness [ Time Frame: change from 3 months to 15 months ]
    assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill

  11. Body weight [ Time Frame: change from baseline to 3 months ]
    measured on a scale digital weight

  12. Body weight [ Time Frame: change from 3 months to 15 months ]
    measured on a scale digital weight

  13. Body Mass Index [ Time Frame: change from baseline to 3 months ]
    body height measured by a Seca altimeter

  14. Body Mass Index [ Time Frame: change from 3 months to 15 months ]
    body height measured by a Seca altimeter

  15. Waist circumference [ Time Frame: change from baseline to 3 months ]
    measured by Seca measurement tape

  16. Waist circumference [ Time Frame: change from 3 months to 15 months ]
    measured by Seca measurement tape

  17. Hip circumference [ Time Frame: change from baseline to 3 months ]
    measured by Seca measurement tape

  18. Hip circumference [ Time Frame: change from 3 months to 15 months ]
    measured by Seca measurement tape



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026296


Locations
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Norway
Frisklivssentrale
Drammen (plus 9 More Communities), Buskerud County, Norway
Frisklivssentrale
Levanger (plus 4 More Communities), Nord-Trøndelag County, Norway
Frisklivssentrale
Bodo (plus 11 More Communities), Nordland County, Norway
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
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Study Director: Riina Kiik, phd Norwegian University of Science and Technology
Study Director: Erik Kyrkjebø, phd Western Norway University of Applied Sciences
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03026296    
Other Study ID Numbers: 2016/546-1
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Physical Fitness
Health Status
Exercise
Tobacco Use Cessation
Quality of Life
Healthy Diet
Health Promotion
Patient Education as Topic
Counseling
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Mental Disorders