Health BehaviorBA1NCT03529357
Biological Age in Worksite Health Promotion
An observational study of Health Behavior and Biomedical Technology, run by University of Copenhagen at 1 site in Denmark.
Trial summary
This cohort study investigates how implementation of Biological Age technology in worksite health promotion, affects health behavior in the general Danish working population. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Biomedical Technology
- How many people
- 5,473 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2007to Jun 2013
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The volunteers are employees in either private or governmental companies. A total of 18 different companies are included in this study, primarily related to banking, pension and pharmaceutical work areas. The Body Age test is voluntary and part of the companies health strategy and fringe benefits.
Who may be able to join
- Males and females interested in their personal health status
- Participants who perform both baseline and follow up test.
Who cannot join
- Use of beta blockers
Trial locations and contacts
1 site in 1 country.
Denmark1 site
University of Copenhagen, Department of Biomedical Sciences
Copenhagen, 2200
About this study
Official title: Implementation of Biological Age in Worksite Health Promotion - a Cohort Study on >4000 Danish Employees and Their Health Risk Reductions
This cohort study investigates how implementation of Biological Age technology in worksite health promotion, affects health behavior in the general Danish working population.
Read the detailed description
This cohort study is designed on the basis of Body Age tests, executed by a private Danish health care company in the period from 2010 to 2013.
The dataset comprises pre- and post Body Age tests from >4000 individuals. They used a standardised protocol and educated staff ( physiotherapists or with a degree in sports science) to carry out the tests. Body Age tests apply biometrics, fitness level and health status data of the employee. The test results are characterized by a Body Age score, which defines the employee's biological age (in years).
This design categorises as a register study why The Danish National Committee is not applied for.
- Conditions
- Health Behavior, Biomedical Technology
- Keywords
- Biological Age, Motivation
- Medical subject headings
- Health Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Age
An algorithm calculates Biological Age, using physiological parameters and biomarkers measured during the test.
Measured: The Biological Age is calculated at baseline and at one year follow up
Secondary outcomes (9)
BMI
BodyMassIndex is a major risk factor for developing lifestyle related diseases.
Measured: Measured at baseline and at one year follow up
Bodyweight
The weight in kilograms of each individual
Measured: Measured at baseline and at one year follow up
FM
Fat Mass is important to look at isolated in reference to whole bodyweight
Measured: Measured at baseline and at one year follow up
FFM
Fat Free Mass is important to look at isolated in reference to Whole bodyweight
Measured: Measured at baseline and at one year follow up
BP
Bloodpressure as a result from systolic and diastolic bloodpressure
Measured: Measured at baseline and at one year follow up
VO2max
Maximal Oxygen consumption
Measured: Measured at baseline and at one year follow up
BG
Blood Glucose
Measured: Measured at baseline and at one year follow up
HDL
High Density Lipoprotein
Measured: Measured at baseline and at one year follow up
LDL
Low Density Lipoprotein
Measured: Measured at baseline and at one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study startJun 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,473 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Metropolitan University College, Technical University of Denmark
- Responsible party
- Principal investigator, Jørn Wulff Helge, University of Copenhagen
- Investigators
- Jørn W Helge, Prof., Principal investigator, BMI, Xlab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529357
- Sponsor's protocol ID
- BiologicalAge1
- Acronym
- BA1
- Status last verified
- May 2018
- First submitted
- 7 May 2018
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Biological Age in Worksite Health Promotion - a Cohort Study on >4000 Danish Employees and Their Health Risk Reductions
- ClinicalTrials.gov ID
- NCT03529357
- Acronym / sponsor ID
- BA1 / BiologicalAge1
- Conditions
- Health Behavior, Biomedical Technology
- Keywords
- Biological Age, Motivation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,473 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Metropolitan University College, Technical University of Denmark
- Study start
- Jun 2007 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cohort study investigates how implementation of Biological Age technology in worksite health promotion, affects health behavior in the general Danish working population.
Detailed description
This cohort study is designed on the basis of Body Age tests, executed by a private Danish health care company in the period from 2010 to 2013.
The dataset comprises pre- and post Body Age tests from >4000 individuals. They used a standardised protocol and educated staff ( physiotherapists or with a degree in sports science) to carry out the tests. Body Age tests apply biometrics, fitness level and health status data of the employee. The test results are characterized by a Body Age score, which defines the employee's biological age (in years).
This design categorises as a register study why The Danish National Committee is not applied for.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The volunteers are employees in either private or governmental companies. A total of 18 different companies are included in this study, primarily related to banking, pension and pharmaceutical work areas. The Body Age test is voluntary and part of the companies health strategy and fringe benefits.
Key inclusion criteria (2 listed)
- Males and females interested in their personal health status
- Participants who perform both baseline and follow up test.
Key exclusion criteria (1 listed)
- Use of beta blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biological Age
Time frame: The Biological Age is calculated at baseline and at one year follow up
An algorithm calculates Biological Age, using physiological parameters and biomarkers measured during the test.
9 secondary outcomes
BMI
Time frame: Measured at baseline and at one year follow up
Bodyweight
Time frame: Measured at baseline and at one year follow up
FM
Time frame: Measured at baseline and at one year follow up
FFM
Time frame: Measured at baseline and at one year follow up
BP
Time frame: Measured at baseline and at one year follow up
VO2max
Time frame: Measured at baseline and at one year follow up
BG
Time frame: Measured at baseline and at one year follow up
HDL
Time frame: Measured at baseline and at one year follow up
LDL
Time frame: Measured at baseline and at one year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jørn W Helge, Prof. principal investigator
BMI, Xlab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior and Biomedical Technology, run by University of Copenhagen at 1 site 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 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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Biological Age (time frame: The Biological Age is calculated at baseline and at one year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2018.