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.

Study Overview

• Status: Completed
• Conditions: Obesity; Musculoskeletal Disease; Psychological Disorder
• Intervention / Treatment: Behavioral: Healthy Life Center

• Study Type: Interventional
• Enrollment (Actual): 1022
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical activity	measured by accelerometer (ActiGraph GT3X+) for seven consecutive days	change from baseline to 3 months
physical activity	measured by accelerometer (ActiGraph GT3X+) for seven consecutive days	change from 3 months to 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	assessed by questionnaire	change from baseline to 3 months
Physical activity	assessed by questionnaire	change from 3 months to 15 months
health related quality of life	assessed by SF-36 questionnaire	change from baseline to 3 months
health related quality of life	assessed by SF-36 questionnaire	change from 3 months to 15 months
Diet	assessed by questionnaire	change from baseline to 3 months
Diet	assessed by questionnaire	change from 3 months to 15 months
Tobacco use	assessed by questionnaire	change from baseline to 3 months
Tobacco use	assessed by questionnaire	change from 3 months to 15 months
Physical fitness	assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill	change from baseline to 3 months
Physical fitness	assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill	change from 3 months to 15 months
Body weight	measured on a scale digital weight	change from baseline to 3 months
Body weight	measured on a scale digital weight	change from 3 months to 15 months
Body Mass Index	body height measured by a Seca altimeter	change from baseline to 3 months
Body Mass Index	body height measured by a Seca altimeter	change from 3 months to 15 months
Waist circumference	measured by Seca measurement tape	change from baseline to 3 months
Waist circumference	measured by Seca measurement tape	change from 3 months to 15 months
Hip circumference	measured by Seca measurement tape	change from baseline to 3 months
Hip circumference	measured by Seca measurement tape	change from 3 months to 15 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Helsedirektoratet Frisklivssentraler

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Counseling; Quality of Life; Health Status; Health Promotion; Physical Fitness; Patient Education as Topic; Tobacco Use Cessation; Healthy Diet
• Additional Relevant MeSH Terms: Mental Disorders; Musculoskeletal Diseases
• Other Study ID Numbers: 2016/546-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No