OverweightPhase 1FINALE-HealthNCT01015716
Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Intervention to Reduce Weight and Increase Workability in Health Care Workers
A Phase 1 study testing Intervention-group in people with Overweight and Physical Capacity, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate whether a 1 year worksite based life-style intervention can reduce body weight and increase physical capacity and subsequently reduce musculoskeletal disorders and increase workability in overweight health care workers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Physical Capacity, Musculoskeletal Diseases
- What is being tested?
- Intervention-group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to May 2012
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight Health care workers, working more than 15 hours pr week
Who cannot join
- Pregnancy, angina pectoris and life-threatening diseases according to safty regulations for physical evaluation methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Life-style Intervention to Reduce Weight and Increase Workability in Health Care Workers
The purpose of this study is to evaluate whether a 1 year worksite based life-style intervention can reduce body weight and increase physical capacity and subsequently reduce musculoskeletal disorders and increase workability in overweight health care workers.
Read the detailed description
Health care workers have a high rate of musculoskeletal disorders and sick leave and a poor workability and physical fitness. Most studies have focused on increasing physical fitness in order to increase workability and to reduce musculoskeletal disorders and sick leave. Studies however also show that many health care workers are obese and obesity has been linked to poor workability.
Limited research is available on the effect of reducing body-weight in this group in order to increase workability and to decrease musculoskeletal disorders and sick leave.
This study introduces a combined worksite based lifestyle intervention consisting of physical exercise, dietary counseling and cognitive behavioral training aimed at reducing weight in health care workers.
On specific worksites, health care workers are cluster randomized to either intervention or control group.
Effects on physical capacity, body composition, musculoskeletal disorders, workability and sick leave are evaluated before and after a 1 year intervention period
- Being tested
- Intervention-group, Control-group
- Keywords
- Weight loss, Physical activity, Cognitive Behavioral Training
- Medical subject headings
- Overweight, Musculoskeletal Diseases, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention-groupBehavioural
Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention
Control-groupBehavioural
Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics
| Study group | Role | What they receive |
|---|---|---|
| Control-group | Active comparator | Invitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics Receives: Behavioral: Control-group |
| Intervention-group | Experimental | Physical exercise, dietary counseling and cognitive behavioral training as a combined intervention Receives: Behavioral: Intervention-group |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Measured: 3 months
Weight loss
Measured: 1 year
Secondary outcomes (4)
Muscle strength
Measured: 3 months
Aerobic capacity
Measured: 3 months
Health Check
Measured: 1 year
Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Working Environment Research Foundation, The Ministry of Culture Committee on Sports Research, Denmark
- Responsible party
- Sponsor
- Investigators
- Jeanette R. Christensen, M.Sc. PT, Principal investigator, Department of Sport Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015716
- Sponsor's protocol ID
- FINALE-Health
- Acronym
- FINALE-Health
- Status last verified
- Oct 2012
- First submitted
- 17 Nov 2009
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Christensen JR, Pajevic M, Ilvig PM, Sogaard K, Jessen-Winge C. Why people engage in a weight loss intervention at their workplace - a stratified case study. BMC Public Health. 2019 Jan 7;19(1):20. doi: 10.1186/s12889-018-6346-0.
PubMed 30612549Christensen JR, Kongstad MB, Sjogaard G, Sogaard K. Sickness Presenteeism Among Health Care Workers and the Effect of BMI, Cardiorespiratory Fitness, and Muscle Strength. J Occup Environ Med. 2015 Dec;57(12):e146-52. doi: 10.1097/JOM.0000000000000576.
PubMed 26641838Christensen JR, Overgaard K, Carneiro IG, Holtermann A, Sogaard K. Weight loss among female health care workers--a 1-year workplace based randomized controlled trial in the FINALE-health study. BMC Public Health. 2012 Aug 8;12:625. doi: 10.1186/1471-2458-12-625.
PubMed 22871173Christensen JR, Faber A, Ekner D, Overgaard K, Holtermann A, Sogaard K. Diet, physical exercise and cognitive behavioral training as a combined workplace based intervention to reduce body weight and increase physical capacity in health care workers - a randomized controlled trial. BMC Public Health. 2011 Aug 27;11:671. doi: 10.1186/1471-2458-11-671.
PubMed 21871113Holtermann A, Jorgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjogaard G, Sogaard K. Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE. BMC Public Health. 2010 Mar 9;10:120. doi: 10.1186/1471-2458-10-120.
PubMed 20214807
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise, Dietary Counseling and Cognitive Behavioral Training as a Combined Life-style Intervention to Reduce Weight and Increase Workability in Health Care Workers
- ClinicalTrials.gov ID
- NCT01015716
- Acronym / sponsor ID
- FINALE-Health / FINALE-Health
- Keywords
- Weight loss, Physical activity, Cognitive Behavioral Training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Working Environment Research Foundation, The Ministry of Culture Committee on Sports Research, Denmark
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Nov 2009 (estimated)
- 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.
The purpose of this study is to evaluate whether a 1 year worksite based life-style intervention can reduce body weight and increase physical capacity and subsequently reduce musculoskeletal disorders and increase workability in overweight health care workers.
Detailed description
Health care workers have a high rate of musculoskeletal disorders and sick leave and a poor workability and physical fitness. Most studies have focused on increasing physical fitness in order to increase workability and to reduce musculoskeletal disorders and sick leave. Studies however also show that many health care workers are obese and obesity has been linked to poor workability.
Limited research is available on the effect of reducing body-weight in this group in order to increase workability and to decrease musculoskeletal disorders and sick leave.
This study introduces a combined worksite based lifestyle intervention consisting of physical exercise, dietary counseling and cognitive behavioral training aimed at reducing weight in health care workers.
On specific worksites, health care workers are cluster randomized to either intervention or control group.
Effects on physical capacity, body composition, musculoskeletal disorders, workability and sick leave are evaluated before and after a 1 year intervention period
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-group | Active comparator | Behavioral: Control-groupInvitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics |
| Intervention-group | Experimental | Behavioral: Intervention-groupPhysical exercise, dietary counseling and cognitive behavioral training as a combined intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Overweight Health care workers, working more than 15 hours pr week
Key exclusion criteria (1 listed)
- Pregnancy, angina pectoris and life-threatening diseases according to safty regulations for physical evaluation methods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention-groupPhysical exercise, dietary counseling and cognitive behavioral training as a combined intervention | Behavioural | Intervention-group |
| Control-groupInvitation to attend a monthly seminar of 2 hour duration on a wide range of health related topics | Behavioural | Control-group |
Primary outcome
weight loss
Time frame: 3 months
Weight loss
Time frame: 1 year
4 secondary outcomes
Muscle strength
Time frame: 3 months
Aerobic capacity
Time frame: 3 months
Health Check
Time frame: 1 year
Questionnaire
Time frame: 1 year
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 17 Oct 2012.
- Derived from this study: PubMed 30612549Christensen JR, Pajevic M, Ilvig PM, Sogaard K, Jessen-Winge C. Why people engage in a weight loss intervention at their workplace - a stratified case study. BMC Public Health. 2019 Jan 7;19(1):20. doi: 10.1186/s12889-018-6346-0.
- Derived from this study: PubMed 26641838Christensen JR, Kongstad MB, Sjogaard G, Sogaard K. Sickness Presenteeism Among Health Care Workers and the Effect of BMI, Cardiorespiratory Fitness, and Muscle Strength. J Occup Environ Med. 2015 Dec;57(12):e146-52. doi: 10.1097/JOM.0000000000000576.
- Derived from this study: PubMed 22871173Christensen JR, Overgaard K, Carneiro IG, Holtermann A, Sogaard K. Weight loss among female health care workers--a 1-year workplace based randomized controlled trial in the FINALE-health study. BMC Public Health. 2012 Aug 8;12:625. doi: 10.1186/1471-2458-12-625.
- Derived from this study: PubMed 21871113Christensen JR, Faber A, Ekner D, Overgaard K, Holtermann A, Sogaard K. Diet, physical exercise and cognitive behavioral training as a combined workplace based intervention to reduce body weight and increase physical capacity in health care workers - a randomized controlled trial. BMC Public Health. 2011 Aug 27;11:671. doi: 10.1186/1471-2458-11-671.
- Derived from this study: PubMed 20214807Holtermann A, Jorgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjogaard G, Sogaard K. Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE. BMC Public Health. 2010 Mar 9;10:120. doi: 10.1186/1471-2458-10-120.
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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.
Jeanette R. Christensen, M.Sc. PT principal investigator
Department of Sport Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intervention-group in people with Overweight and Physical Capacity, run by University of Aarhus 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 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 17 Oct 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
weight loss (time frame: 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 NCT01015716, which also lists 5 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 17 Oct 2012.