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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity, Musculoskeletal Disease, Psychological Disorder

Intervention / Treatment
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* Behavioral: Healthy Life Center


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participators in HLCs<br>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<br>* 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<br>* Other names: Frisklivssentralen (Norwegian);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Fitness, Health Status, Exercise, Tobacco Use Cessation, Quality of Life, Healthy Diet, Health Promotion, Patient Education as Topic, Counseling