NCT03026296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,022

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

3.3 years

First QC Date

January 17, 2017

Last Update Submit

February 26, 2020

Conditions

Keywords

Physical FitnessHealth StatusExerciseTobacco Use CessationQuality of LifeHealthy DietHealth PromotionPatient Education as TopicCounseling

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (18)

  • Physical activity

    change from baseline to 3 months

  • Physical activity

    change from 3 months to 15 months

  • health related quality of life

    change from baseline to 3 months

  • health related quality of life

    change from 3 months to 15 months

  • Diet

    change from baseline to 3 months

  • +13 more secondary outcomes

Study Arms (1)

Participators in HLCs

EXPERIMENTAL

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

Interventions

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

Also known as: Frisklivssentralen (Norwegian)
Participators in HLCs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • having participated in an HLC the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Frisklivssentrale

Drammen (plus 9 More Communities), Buskerud, Norway

Location

Frisklivssentrale

Levanger (plus 4 More Communities), Nord-Trøndelag County, Norway

Location

Frisklivssentrale

Bodo (plus 11 More Communities), Nordland County, Norway

Location

Frisklivssentrale

Laerdal (plus 6 More Communities), Sogn Og Fjordane County, Norway

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Musculoskeletal DiseasesObesityMental DisordersMotor ActivityTobacco Use Cessation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorHealth Behavior

Study Officials

  • Riina Kiik, phd

    Norwegian University of Science and Technology

    STUDY DIRECTOR
  • Erik Kyrkjebø, phd

    Western Norway University of Applied Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

January 20, 2017

Study Start

August 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations