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

Primary Purpose

Musculoskeletal Disease, Obesity, Psychological Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Healthy Life Center
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Musculoskeletal Disease focused on measuring Physical Fitness, Health Status, Exercise, Tobacco Use Cessation, Quality of Life, Healthy Diet, Health Promotion, Patient Education as Topic, Counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Frisklivssentrale
  • Frisklivssentrale
  • Frisklivssentrale
  • Frisklivssentrale

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participators in HLCs

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Physical activity
assessed by questionnaire
Physical activity
assessed by questionnaire
health related quality of life
assessed by SF-36 questionnaire
health related quality of life
assessed by SF-36 questionnaire
Diet
assessed by questionnaire
Diet
assessed by questionnaire
Tobacco use
assessed by questionnaire
Tobacco use
assessed by questionnaire
Physical fitness
assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
Physical fitness
assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
Body weight
measured on a scale digital weight
Body weight
measured on a scale digital weight
Body Mass Index
body height measured by a Seca altimeter
Body Mass Index
body height measured by a Seca altimeter
Waist circumference
measured by Seca measurement tape
Waist circumference
measured by Seca measurement tape
Hip circumference
measured by Seca measurement tape
Hip circumference
measured by Seca measurement tape

Full Information

First Posted
January 17, 2017
Last Updated
February 26, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
Western Norway University of Applied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03026296
Brief Title
Healthy Life Centers - Municipal Health Care Service for Lifestyle Changes - a Multicenter Intervention Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Western Norway University of Applied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disease, Obesity, Psychological Disorder
Keywords
Physical Fitness, Health Status, Exercise, Tobacco Use Cessation, Quality of Life, Healthy Diet, Health Promotion, Patient Education as Topic, Counseling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1022 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participators in HLCs
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Healthy Life Center
Other Intervention Name(s)
Frisklivssentralen (Norwegian)
Intervention Description
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
Primary Outcome Measure Information:
Title
physical activity
Description
measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
Time Frame
change from baseline to 3 months
Title
physical activity
Description
measured by accelerometer (ActiGraph GT3X+) for seven consecutive days
Time Frame
change from 3 months to 15 months
Secondary Outcome Measure Information:
Title
Physical activity
Description
assessed by questionnaire
Time Frame
change from baseline to 3 months
Title
Physical activity
Description
assessed by questionnaire
Time Frame
change from 3 months to 15 months
Title
health related quality of life
Description
assessed by SF-36 questionnaire
Time Frame
change from baseline to 3 months
Title
health related quality of life
Description
assessed by SF-36 questionnaire
Time Frame
change from 3 months to 15 months
Title
Diet
Description
assessed by questionnaire
Time Frame
change from baseline to 3 months
Title
Diet
Description
assessed by questionnaire
Time Frame
change from 3 months to 15 months
Title
Tobacco use
Description
assessed by questionnaire
Time Frame
change from baseline to 3 months
Title
Tobacco use
Description
assessed by questionnaire
Time Frame
change from 3 months to 15 months
Title
Physical fitness
Description
assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
Time Frame
change from baseline to 3 months
Title
Physical fitness
Description
assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill
Time Frame
change from 3 months to 15 months
Title
Body weight
Description
measured on a scale digital weight
Time Frame
change from baseline to 3 months
Title
Body weight
Description
measured on a scale digital weight
Time Frame
change from 3 months to 15 months
Title
Body Mass Index
Description
body height measured by a Seca altimeter
Time Frame
change from baseline to 3 months
Title
Body Mass Index
Description
body height measured by a Seca altimeter
Time Frame
change from 3 months to 15 months
Title
Waist circumference
Description
measured by Seca measurement tape
Time Frame
change from baseline to 3 months
Title
Waist circumference
Description
measured by Seca measurement tape
Time Frame
change from 3 months to 15 months
Title
Hip circumference
Description
measured by Seca measurement tape
Time Frame
change from baseline to 3 months
Title
Hip circumference
Description
measured by Seca measurement tape
Time Frame
change from 3 months to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riina Kiik, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erik Kyrkjebø, phd
Organizational Affiliation
Western Norway University of Applied Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Frisklivssentrale
City
Drammen (plus 9 More Communities)
State/Province
Buskerud County
Country
Norway
Facility Name
Frisklivssentrale
City
Levanger (plus 4 More Communities)
State/Province
Nord-Trøndelag County
Country
Norway
Facility Name
Frisklivssentrale
City
Bodo (plus 11 More Communities)
State/Province
Nordland County
Country
Norway
Facility Name
Frisklivssentrale
City
Laerdal (plus 6 More Communities)
State/Province
Sogn Og Fjordane County
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32988939
Citation
Blom EE, Aadland E, Solbraa AK, Oldervoll LM. Healthy Life Centres: a 3-month behaviour change programme's impact on participants' physical activity levels, aerobic fitness and obesity: an observational study. BMJ Open. 2020 Sep 28;10(9):e035888. doi: 10.1136/bmjopen-2019-035888.
Results Reference
derived
Links:
URL
https://helsedirektoratet.no/folkehelse/frisklivssentraler
Description
Helsedirektoratet Frisklivssentraler

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

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