Sedentary LifestyleNCT01759927
Investigating the Effectiveness of Exercise Coaching on the Physical Activity Behavior of Physically Inactive Employees.
A study testing physical activity coaching in people with Sedentary Lifestyle, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The primary aim of this study is to investigate if and how a physical activity counselor can offer an added value in exercise promotion in physically inactive employees. We will explore if the physical activity counselor in the workplace setting can motivate sedentary employees to engage into systematic participation… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- physical activity coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Mar 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employee of Janssen Pharmaceutics Belgium
- Physically inactive lifestyle (not reaching 150 minutes of moderate-to-vigorous physical activity a week)
- PAR-Q questionnaire all answers negative, if one or more answers are positive a permission of a physician is necessary
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Katholieke Universiteit Leuven - Faculty of Kinesiology and Rehabilitation Sciences
Leuven, Vlaams Brabant, 3000
About this study
Official title: Investigating the Effectiveness of Exercise Coaching on the Physical Activity Behavior of Physically Inactive Employees in a Company in Flanders: a Randomized Control Trial.
The primary aim of this study is to investigate if and how a physical activity counselor can offer an added value in exercise promotion in physically inactive employees. We will explore if the physical activity counselor in the workplace setting can motivate sedentary employees to engage into systematic participation in sports and/or exercise by means of a short term coaching of 12 weeks. We aim to include 300 employees in the physical activity coaching process.
Read the detailed description
Being physically active on a regular basis has many health benefits. Nevertheless, the majority of the Belgian population doesn't reach the recommended amount and intensity of physical activity to profit from these health benefits. A physical activity counselor can possibly play a crucial role for these physically inactive individuals. He/she can design an individualized exercise program to stimulate the person to become lifelong physical active. Research has shown that exercise promotion at work can result in a lower absenteeism, prevention of burn-out and a positive corporate identity.
- Conditions
- Sedentary Lifestyle
- Being tested
- physical activity coaching
- Keywords
- Physical activity counselor, Workplace intervention, Active and healthy lifestyle
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity coachingBehavioural
After measuring physical actity, physical fitness level, anthropometric and psychosocial variables a personalized 12 week physical activity program is made (=baseline). The intervention consisted of two face-to-face counselling sessions at the start of the intervention, short contacts by e-mail or telephone at weeks 3, 6 and 9, and two face-to-face counselling sessions at the end of the intervention. Employees exercise on their own. After 12 weeks and 6 months all measures are repeated.
| Study group | Role | What they receive |
|---|---|---|
| Control condition | No intervention | Physically inactive employees are measured on anthropometrics, fitness and psycho-social variables. |
| Physical Activity Coaching | Experimental | Physically inactive employees receiving a 12-week behavioural support intervention grounded in self-determination theory. Receives: Behavioral: physical activity coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objective measure of degree of physical activity
Sensewear: accelerometer worn on the upper arm during 7 consecutive days measuring the physical activity pattern during this period
Measured: baseline, 12 weeks, 6 months
Secondary outcomes (1)
Change in health-related anthropometric measures
Weight, Abdominal circumference, Bodycomposition (fat- and musclepercentage)
Measured: baseline, 12 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Responsible party
- Principal investigator, Jan Seghers, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jan Seghers, Dr, Principal investigator, Faculty of Kinesiology and Rehabilitation Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759927
- Sponsor's protocol ID
- S54788
- Status last verified
- Dec 2015
- First submitted
- 30 Dec 2012
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arrogi A, Schotte A, Bogaerts A, Boen F, Seghers J. Increasing Employees' Health by Workplace Physical Activity Counseling: The Mediating Role of Step-Based Physical Activity Behavior Change. J Phys Act Health. 2019 Mar 1;16(3):205-213. doi: 10.1123/jpah.2018-0148. Epub 2019 Feb 15.
PubMed 30764729Arrogi A, Schotte A, Bogaerts A, Boen F, Seghers J. Short- and long-term effectiveness of a three-month individualized need-supportive physical activity counseling intervention at the workplace. BMC Public Health. 2017 Jan 9;17(1):52. doi: 10.1186/s12889-016-3965-1.
PubMed 28069016
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effectiveness of Exercise Coaching on the Physical Activity Behavior of Physically Inactive Employees in a Company in Flanders: a Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT01759927
- Acronym / sponsor ID
- S54788
- Conditions
- Sedentary Lifestyle
- Keywords
- Physical activity counselor, Workplace intervention, Active and healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutica
- Study start
- Feb 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Jan 2013 (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 primary aim of this study is to investigate if and how a physical activity counselor can offer an added value in exercise promotion in physically inactive employees. We will explore if the physical activity counselor in the workplace setting can motivate sedentary employees to engage into systematic participation in sports and/or exercise by means of a short term coaching of 12 weeks. We aim to include 300 employees in the physical activity coaching process.
Detailed description
Being physically active on a regular basis has many health benefits. Nevertheless, the majority of the Belgian population doesn't reach the recommended amount and intensity of physical activity to profit from these health benefits. A physical activity counselor can possibly play a crucial role for these physically inactive individuals. He/she can design an individualized exercise program to stimulate the person to become lifelong physical active. Research has shown that exercise promotion at work can result in a lower absenteeism, prevention of burn-out and a positive corporate identity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control condition | No intervention | –Physically inactive employees are measured on anthropometrics, fitness and psycho-social variables. |
| Physical Activity Coaching | Experimental | Behavioral: physical activity coachingPhysically inactive employees receiving a 12-week behavioural support intervention grounded in self-determination theory. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employee of Janssen Pharmaceutics Belgium
- Physically inactive lifestyle (not reaching 150 minutes of moderate-to-vigorous physical activity a week)
- PAR-Q questionnaire all answers negative, if one or more answers are positive a permission of a physician is necessary
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| physical activity coachingAfter measuring physical actity, physical fitness level, anthropometric and psychosocial variables a personalized 12 week physical activity program is made (=baseline). The intervention consisted of two face-to-face counselling sessions at the start of the intervention, short contacts by e-mail or telephone at weeks 3, 6 and 9, and two face-to-face counselling sessions at the end of the intervention. Employees exercise on their own. After 12 weeks and 6 months all measures are repeated. | Behavioural | Physical Activity Coaching |
Primary outcome
Change in objective measure of degree of physical activity
Time frame: baseline, 12 weeks, 6 months
Sensewear: accelerometer worn on the upper arm during 7 consecutive days measuring the physical activity pattern during this period
1 secondary outcome
Change in health-related anthropometric measures
Time frame: baseline, 12 weeks, 6 months
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 3 Dec 2015.
- Derived from this study: PubMed 30764729Arrogi A, Schotte A, Bogaerts A, Boen F, Seghers J. Increasing Employees' Health by Workplace Physical Activity Counseling: The Mediating Role of Step-Based Physical Activity Behavior Change. J Phys Act Health. 2019 Mar 1;16(3):205-213. doi: 10.1123/jpah.2018-0148. Epub 2019 Feb 15.
- Derived from this study: PubMed 28069016Arrogi A, Schotte A, Bogaerts A, Boen F, Seghers J. Short- and long-term effectiveness of a three-month individualized need-supportive physical activity counseling intervention at the workplace. BMC Public Health. 2017 Jan 9;17(1):52. doi: 10.1186/s12889-016-3965-1.
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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.
Jan Seghers, Dr principal investigator
Faculty of Kinesiology and Rehabilitation Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity coaching in people with Sedentary Lifestyle, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 3 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 3 Dec 2015. 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 Belgium. 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?
Change in objective measure of degree of physical activity (time frame: baseline, 12 weeks, 6 months). 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 NCT01759927, which also lists 2 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 3 Dec 2015.