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Health PreventionPhase 2HEALTHCHANGENCT01366950

Work Place Health Promotion: a Change Project

A Phase 2 study testing Intelligent physical activity in people with Health Prevention, run by University of Southern Denmark at 5 sites in Denmark.

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

The purpose of this study is to determine if intelligent physical exercise training can increase the productivity of office workers in Denmark. Effects of intervention is measured after 1 and 2 years. The project is driven as a change project. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Health Prevention
What is being tested?
Intelligent physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
5 sitesDenmark
Study dates
Jun 2011to Dec 2014
Phase
Phase 2
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Office workers

Who cannot join

  • Pregnancy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Denmark5 sites

  • Nestlé

    Copenhagen

  • Esbjerg Municipality

    Esbjerg

  • National Board of Social Sciences

    Odense and Copenhagen

  • TDC

    Sønderborg, 6400

  • Varde Kommune

    Varde, 6800

Other trials in Denmark

About this study

Official title: Work Place Health Promotion as a Change Project

The purpose of this study is to determine if intelligent physical exercise training can increase the productivity of office workers in Denmark. Effects of intervention is measured after 1 and 2 years.

The project is driven as a change project.

The investigators measure productivity as:

  • Individual health
  • Sick leave
  • Retention at the workplace
Being tested
Intelligent physical activity

What participants receive

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

  • Intelligent physical activityBehavioural

    Also called Change project, Productivity

    30 minutes of moderate activity 6 days a week and 45 minutes of high intensity training 1 day a week. Moderate activity is monitored in diaries and high intensity training is monitored by a trainer.

Study groups in NCT01366950
Study groupRoleWhat they receive
Excercise groupExperimentalNot described
Receives: Behavioral: Intelligent physical activity
ReferenceNo interventionNot described

What is being measured

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

  1. aerobic capacity

    Measured: After 1 and 2 years

Secondary outcomes (3)

  1. sick leave

    Measured: After 1 and 2 years

  2. Individual productivity

    Measured: After 1 and 2 years

  3. Retention

    Measured: After 1 and 2 years

Timeline

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

  1. First posted6 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2013
  4. Study completionDec 2014

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 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
406 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01366950
Sponsor's protocol ID
S-20110051
Acronym
HEALTHCHANGE
Status last verified
Dec 2016
First submitted
2 Jun 2011
Last updated
29 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Christiansen HJ, Sogaard K, Justesen JB, Sjogaard G, Dalager T. Long Term Cardiovascular Health Effects of Intelligent Physical Exercise Training Among Office Workers-A 2 Year Follow up of a Randomized Controlled Trial. J Occup Environ Med. 2023 Oct 1;65(10):813-819. doi: 10.1097/JOM.0000000000002892. Epub 2023 May 23.

    PubMed 37231634

  • Justesen JB, Sogaard K, Dalager T, Christensen JR, Sjogaard G. The Effect of Intelligent Physical Exercise Training on Sickness Presenteeism and Absenteeism Among Office Workers. J Occup Environ Med. 2017 Oct;59(10):942-948. doi: 10.1097/JOM.0000000000001101.

    PubMed 28800039

  • Sjogaard G, Justesen JB, Murray M, Dalager T, Sogaard K. A conceptual model for worksite intelligent physical exercise training--IPET--intervention for decreasing life style health risk indicators among employees: a randomized controlled trial. BMC Public Health. 2014 Jun 26;14:652. doi: 10.1186/1471-2458-14-652.

    PubMed 24964869

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intelligent physical activity in people with Health Prevention, run by University of Southern Denmark at 5 sites in Denmark.

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 1 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 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

aerobic capacity (time frame: After 1 and 2 years). 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 NCT01366950, which also lists 3 linked publications.

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 29 Dec 2016.

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