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Musculoskeletal DiseaseNCT03026296

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

A study testing Healthy Life Center in people with Musculoskeletal Disease and Obesity, run by Norwegian University of Science and Technology at 4 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Healthy Life Center
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,022 participants
Where
4 sitesNorway
Study dates
Aug 2016to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • having participated in an HLC the previous 6 months

Trial locations and contacts

4 sites in 1 country.

Norway4 sites

  • Frisklivssentrale

    Bodo (plus 11 More Communities), Nordland County

  • Frisklivssentrale

    Drammen (plus 9 More Communities), Buskerud

  • Frisklivssentrale

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

  • Frisklivssentrale

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

Other trials in Norway

About this 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

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.

Being tested
Healthy Life Center
Keywords
Physical Fitness, Health Status, Exercise, Tobacco Use Cessation, Quality of Life, Healthy Diet, Health Promotion, Patient Education as Topic, Counseling
Medical subject headings
Musculoskeletal Diseases, Obesity, Mental Disorders, Motor Activity, Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Healthy Life CenterBehavioural

    Also called Frisklivssentralen (Norwegian)

    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

Study groups in NCT03026296
Study groupRoleWhat they receive
Participators in HLCsExperimentalAdults 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
Receives: Behavioral: Healthy Life Center

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. physical activity

    measured by accelerometer (ActiGraph GT3X+) for seven consecutive days

    Measured: change from baseline to 3 months

  2. physical activity

    measured by accelerometer (ActiGraph GT3X+) for seven consecutive days

    Measured: change from 3 months to 15 months

Secondary outcomes (18)

  1. Physical activity

    assessed by questionnaire

    Measured: change from baseline to 3 months

  2. Physical activity

    assessed by questionnaire

    Measured: change from 3 months to 15 months

  3. health related quality of life

    assessed by SF-36 questionnaire

    Measured: change from baseline to 3 months

  4. health related quality of life

    assessed by SF-36 questionnaire

    Measured: change from 3 months to 15 months

  5. Diet

    assessed by questionnaire

    Measured: change from baseline to 3 months

  6. Diet

    assessed by questionnaire

    Measured: change from 3 months to 15 months

  7. Tobacco use

    assessed by questionnaire

    Measured: change from baseline to 3 months

  8. Tobacco use

    assessed by questionnaire

    Measured: change from 3 months to 15 months

  9. Physical fitness

    assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill

    Measured: change from baseline to 3 months

  10. Physical fitness

    assessed by a standardized progressive walking protocol to a submaximal workload on a treadmill

    Measured: change from 3 months to 15 months

  11. Body weight

    measured on a scale digital weight

    Measured: change from baseline to 3 months

  12. Body weight

    measured on a scale digital weight

    Measured: change from 3 months to 15 months

  13. Body Mass Index

    body height measured by a Seca altimeter

    Measured: change from baseline to 3 months

  14. Body Mass Index

    body height measured by a Seca altimeter

    Measured: change from 3 months to 15 months

  15. Waist circumference

    measured by Seca measurement tape

    Measured: change from baseline to 3 months

  16. Waist circumference

    measured by Seca measurement tape

    Measured: change from 3 months to 15 months

  17. Hip circumference

    measured by Seca measurement tape

    Measured: change from baseline to 3 months

  18. Hip circumference

    measured by Seca measurement tape

    Measured: change from 3 months to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2017 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,022 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026296
Sponsor's protocol ID
2016/546-1
Status last verified
Feb 2020
First submitted
17 Jan 2017
Last updated
28 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32988939

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Life Center in people with Musculoskeletal Disease and Obesity, run by Norwegian University of Science and Technology at 4 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

physical activity (time frame: change from baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03026296, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.

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