Clinical trial NCT03026296: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Western Norway University of Applied Sciences
First posted: 2017-01-20
Enrollment: 1022
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: physical activity
timeFrame: change from baseline to 3 months
measure: physical activity
timeFrame: change from 3 months to 15 months
Secondary outcomes:
measure: Physical activity
timeFrame: change from baseline to 3 months
measure: Physical activity
timeFrame: change from 3 months to 15 months
measure: health related quality of life
timeFrame: change from baseline to 3 months
measure: health related quality of life
timeFrame: change from 3 months to 15 months
measure: Diet
timeFrame: change from baseline to 3 months
measure: Diet
timeFrame: change from 3 months to 15 months
measure: Tobacco use
timeFrame: change from baseline to 3 months
measure: Tobacco use
timeFrame: change from 3 months to 15 months
measure: Physical fitness
timeFrame: change from baseline to 3 months
measure: Physical fitness
timeFrame: change from 3 months to 15 months
measure: Body weight
timeFrame: change from baseline to 3 months
measure: Body weight
timeFrame: change from 3 months to 15 months
measure: Body Mass Index
timeFrame: change from baseline to 3 months
measure: Body Mass Index
timeFrame: change from 3 months to 15 months
measure: Waist circumference
timeFrame: change from baseline to 3 months
measure: Waist circumference
timeFrame: change from 3 months to 15 months
measure: Hip circumference
timeFrame: change from baseline to 3 months
measure: Hip circumference
timeFrame: change from 3 months to 15 months
Other outcomes:
Locations:
city: Drammen (plus 9 More Communities)
country: Norway
facility: Frisklivssentrale
state: Buskerud County
city: Levanger (plus 4 More Communities)
country: Norway
facility: Frisklivssentrale
state: Nord-Trøndelag County
city: Bodo (plus 11 More Communities)
country: Norway
facility: Frisklivssentrale
state: Nordland County
city: Laerdal (plus 6 More Communities)
country: Norway
facility: Frisklivssentrale
state: Sogn Og Fjordane County
Study officials:
affiliation: Norwegian University of Science and Technology
name: Riina Kiik, phd
role: STUDY_DIRECTOR
affiliation: Western Norway University of Applied Sciences
name: Erik Kyrkjebø, phd
role: STUDY_DIRECTOR
References:
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.