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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026296
• Other study ID #: 2016/546-1
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1022
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Musculoskeletal Disease
• Musculoskeletal Diseases
• Obesity
• Psychological Disorder

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity	measured by accelerometer (ActiGraph GT3X+) for seven consecutive days	change from baseline to 3 months
Primary	physical activity	measured by accelerometer (ActiGraph GT3X+) for seven consecutive days	change from 3 months to 15 months
Secondary	Physical activity	assessed by questionnaire	change from baseline to 3 months
Secondary	Physical activity	assessed by questionnaire	change from 3 months to 15 months
Secondary	health related quality of life	assessed by SF-36 questionnaire	change from baseline to 3 months
Secondary	health related quality of life	assessed by SF-36 questionnaire	change from 3 months to 15 months
Secondary	Diet	assessed by questionnaire	change from baseline to 3 months
Secondary	Diet	assessed by questionnaire	change from 3 months to 15 months
Secondary	Tobacco use	assessed by questionnaire	change from baseline to 3 months
Secondary	Tobacco use	assessed by questionnaire	change from 3 months to 15 months
Secondary	Physical fitness	assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill	change from baseline to 3 months
Secondary	Physical fitness	assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill	change from 3 months to 15 months
Secondary	Body weight	measured on a scale digital weight	change from baseline to 3 months
Secondary	Body weight	measured on a scale digital weight	change from 3 months to 15 months
Secondary	Body Mass Index	body height measured by a Seca altimeter	change from baseline to 3 months
Secondary	Body Mass Index	body height measured by a Seca altimeter	change from 3 months to 15 months
Secondary	Waist circumference	measured by Seca measurement tape	change from baseline to 3 months
Secondary	Waist circumference	measured by Seca measurement tape	change from 3 months to 15 months
Secondary	Hip circumference	measured by Seca measurement tape	change from baseline to 3 months
Secondary	Hip circumference	measured by Seca measurement tape	change from 3 months to 15 months

External Links

•   Helsedirektoratet Frisklivssentraler