Motor ActivityNCT02936726
Examining Exercise, Health Coaching and Meditation for University Employees
A study testing Exercise, Health Coaching and Meditation and Exercise and Health Coaching in people with Motor Activity, run by York University at 1 site in Canada.
Trial summary
There is evidently great potential in implementing workplace health promotion programs, but more randomized trials are needed to determine which interventions are worksite-effective in helping to decrease inactive behaviors and increase engagement in healthy lifestyle activities. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Exercise, Health Coaching and Meditation and Exercise and Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Sep 2017
- 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
- Employees at York University;
- fluency in English;
- provision of informed consent
Who cannot join
- currently engaged in regular exercise programs or routines which meet or exceed the Canadian Physical Activity Guidelines
- neurological or musculoskeletal co-morbidities inhibiting participation in exercise program
- > 65 years old;
- medical history of cardiovascular diseases such as CAD and CHF, uncontrolled hypertension
- currently engaged in a mindfulness meditation program or meditative practice at advanced levels;
- not in possession of a smartphone (android/i-phone)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Healthy Staff Initiative Study: Examining Exercise, Health Coaching and Meditation for University Employees: a Randomized Trial
There is evidently great potential in implementing workplace health promotion programs, but more randomized trials are needed to determine which interventions are worksite-effective in helping to decrease inactive behaviors and increase engagement in healthy lifestyle activities. For employers, it could mean improving the health and productivity of employees. For workers, especially those in physically and/or psychologically demanding positions, it could mean developing strength, muscular endurance and agility to reduce musculoskeletal pain while developing the stress reduction skills that reduce long-term sickness and absenteeism risks. While changing behavior in a complex workplace is, as seen in multiple studies, difficult due to the need to change workplace and organizational culture between employers and employees, this study aims to identify the effectiveness of workplace interventions in relation to counseling for university employees to increase overall work fitness without affecting any hierarchal interactions at the work site. Simply put, the investigators will examine the benefits of a workplace exercise and mindfulness (two-prong) intervention (in combination) vs. a group who just receive a workplace exercise intervention. Both interventions will be guided by health coaches. Given the limited research with health coaching and workplace interventions for university workers, the aim is to contribute to a developing research literature. This study is geared to engage university employees at their workplace over a 3 month period. Participants will be assessed through pre and post physical and psychological measures and will also undergo semi-structured interviews (SSI).
Read the detailed description
There is evidently great potential in implementing workplace health promotion programs, but more randomized trials are needed to determine which interventions are worksite-effective in helping to decrease inactive behaviors and increase engagement in healthy lifestyle activities. For employers, it could mean improving the health and productivity of employees. For workers, especially those in physically and/or psychologically demanding positions, it could mean developing strength, muscular endurance and agility to reduce musculoskeletal pain while developing the stress reduction skills that reduce long-term sickness and absenteeism risks. While changing behavior in a complex workplace is, as seen in multiple studies, difficult due to the need to change workplace and organizational culture between employers and employees, this study aims to identify the effectiveness of workplace interventions in relation to counseling for university employees to increase overall work fitness without affecting any hierarchal interactions at the work site. Simply put, the investigators will examine the benefits of a workplace exercise and mindfulness (two-prong) intervention (in combination) vs. a group who just receive a workplace exercise intervention. Both interventions will be guided by health coaches. Given the limited research with health coaching and workplace interventions for university workers, the aim is to contribute to a developing research literature. This study is geared to engage university employees at their workplace over a 3 month period. Participants will be assessed through pre and post physical and psychological measures and will also undergo semi-structured interviews (SSI). The investigators hypothesize that making available these various fitness and well-being programs for university employees will effectively improve their overall fitness (peak VO2) and psychological health (stress, depression, anxiety, work satisfaction), making them more efficient, positive and work-productive. Specifically, the investigators hypothesize that the exercise and mindfulness meditation group will demonstrate significant improvements when compared to the group solely receiving exercise-oriented health coaching. Improvements will be seen across all measures of physical (such as VO2 peak and BMI) and psychological (such as depression, stress, anxiety, work-life balance) function and will be sustained at 3 month follow-up, indicating a more effective means of initiating fitness at the workplace
- Conditions
- Motor Activity
- Being tested
- Exercise, Health Coaching and Meditation, Exercise and Health Coaching
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, Health Coaching and MeditationBehavioural
Comparing Exercise, Health Coaching and Meditation In Combination
Exercise and Health CoachingBehavioural
Comparing Exercise and Health Coaching Alone
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Health Coaching | Active comparator | Walking exercise protocol program, carried out by themselves, over 12 weeks.
Health Coach addresses various topics with participant, half-hour sessions on a weekly (12 sessions) Receives: Behavioral: Exercise and Health Coaching |
| Exercise, Health Coaching and Meditation | Experimental | Walking exercise protocol program, carried out by themselves, over 12 weeks.
Health Coach addresses various topics with participant, half-hour sessions on a weekly (12 sessions)
Mindfulness Meditation intervention will incorporate varied types of MBI techniques 3 times per week for 12 weeks, during work hours and/or during their time on campus (after work hours). Receives: Behavioral: Exercise, Health Coaching and Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 Peak
Assess changes in VO2 peak over time
Measured: Baseline, 12 weeks and 24 weeks
Secondary outcomes (1)
Psychological Questionnaires
Assess changes over time
Measured: Baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Recruitment Completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shalini Moonsammy Persaud, York University
- Investigators
- Shalini Moonsammy Persaud, PhD (cand), Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936726
- Sponsor's protocol ID
- STU 2016 - 121
- Status last verified
- Jan 2020
- First submitted
- 12 Oct 2016
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data is analyzed as group data
Publications
Jakobsen MD, Sundstrup E, Brandt M, Kristensen AZ, Jay K, Stelter R, Lavendt E, Aagaard P, Andersen LL. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 7;15:119. doi: 10.1186/1471-2474-15-119.
PubMed 24708570van Berkel J, Boot CR, Proper KI, Bongers PM, van der Beek AJ. Effectiveness of a worksite mindfulness-based multi-component intervention on lifestyle behaviors. Int J Behav Nutr Phys Act. 2014 Jan 27;11:9. doi: 10.1186/1479-5868-11-9.
PubMed 24467802Marshall AL. Challenges and opportunities for promoting physical activity in the workplace. J Sci Med Sport. 2004 Apr;7(1 Suppl):60-6. doi: 10.1016/s1440-2440(04)80279-2.
PubMed 15214603
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthy Staff Initiative Study: Examining Exercise, Health Coaching and Meditation for University Employees: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02936726
- Acronym / sponsor ID
- STU 2016 - 121
- Conditions
- Motor Activity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 18 Oct 2016 (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.
There is evidently great potential in implementing workplace health promotion programs, but more randomized trials are needed to determine which interventions are worksite-effective in helping to decrease inactive behaviors and increase engagement in healthy lifestyle activities. For employers, it could mean improving the health and productivity of employees. For workers, especially those in physically and/or psychologically demanding positions, it could mean developing strength, muscular endurance and agility to reduce musculoskeletal pain while developing the stress reduction skills that reduce long-term sickness and absenteeism risks. While changing behavior in a complex workplace is, as seen in multiple studies, difficult due to the need to change workplace and organizational culture between employers and employees, this study aims to identify the effectiveness of workplace interventions in relation to counseling for university employees to increase overall work fitness without affecting any hierarchal interactions at the work site. Simply put, the investigators will examine the benefits of a workplace exercise and mindfulness (two-prong) intervention (in combination) vs. a group who just receive a workplace exercise intervention. Both interventions will be guided by health coaches. Given the limited research with health coaching and workplace interventions for university workers, the aim is to contribute to a developing research literature. This study is geared to engage university employees at their workplace over a 3 month period. Participants will be assessed through pre and post physical and psychological measures and will also undergo semi-structured interviews (SSI).
Detailed description
There is evidently great potential in implementing workplace health promotion programs, but more randomized trials are needed to determine which interventions are worksite-effective in helping to decrease inactive behaviors and increase engagement in healthy lifestyle activities. For employers, it could mean improving the health and productivity of employees. For workers, especially those in physically and/or psychologically demanding positions, it could mean developing strength, muscular endurance and agility to reduce musculoskeletal pain while developing the stress reduction skills that reduce long-term sickness and absenteeism risks. While changing behavior in a complex workplace is, as seen in multiple studies, difficult due to the need to change workplace and organizational culture between employers and employees, this study aims to identify the effectiveness of workplace interventions in relation to counseling for university employees to increase overall work fitness without affecting any hierarchal interactions at the work site. Simply put, the investigators will examine the benefits of a workplace exercise and mindfulness (two-prong) intervention (in combination) vs. a group who just receive a workplace exercise intervention. Both interventions will be guided by health coaches. Given the limited research with health coaching and workplace interventions for university workers, the aim is to contribute to a developing research literature. This study is geared to engage university employees at their workplace over a 3 month period. Participants will be assessed through pre and post physical and psychological measures and will also undergo semi-structured interviews (SSI). The investigators hypothesize that making available these various fitness and well-being programs for university employees will effectively improve their overall fitness (peak VO2) and psychological health (stress, depression, anxiety, work satisfaction), making them more efficient, positive and work-productive. Specifically, the investigators hypothesize that the exercise and mindfulness meditation group will demonstrate significant improvements when compared to the group solely receiving exercise-oriented health coaching. Improvements will be seen across all measures of physical (such as VO2 peak and BMI) and psychological (such as depression, stress, anxiety, work-life balance) function and will be sustained at 3 month follow-up, indicating a more effective means of initiating fitness at the workplace
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and Health Coaching | Active comparator | Behavioral: Exercise and Health CoachingWalking exercise protocol program, carried out by themselves, over 12 weeks. Health Coach addresses various topics with participant, half-hour sessions on a weekly (12 sessions) |
| Exercise, Health Coaching and Meditation | Experimental | Behavioral: Exercise, Health Coaching and MeditationWalking exercise protocol program, carried out by themselves, over 12 weeks. Health Coach addresses various topics with participant, half-hour sessions on a weekly (12 sessions) Mindfulness Meditation intervention will incorporate varied types of MBI techniques 3 times per week for 12 weeks, during work hours and/or during their time on campus (after work hours). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employees at York University;
- fluency in English;
- provision of informed consent
Key exclusion criteria (6 listed)
- currently engaged in regular exercise programs or routines which meet or exceed the Canadian Physical Activity Guidelines
- neurological or musculoskeletal co-morbidities inhibiting participation in exercise program
- > 65 years old;
- medical history of cardiovascular diseases such as CAD and CHF, uncontrolled hypertension
- currently engaged in a mindfulness meditation program or meditative practice at advanced levels;
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 |
|---|---|---|
| Exercise, Health Coaching and MeditationComparing Exercise, Health Coaching and Meditation In Combination | Behavioural | Exercise, Health Coaching and Meditation |
| Exercise and Health CoachingComparing Exercise and Health Coaching Alone | Behavioural | Exercise and Health Coaching |
Primary outcome
VO2 Peak
Time frame: Baseline, 12 weeks and 24 weeks
Assess changes in VO2 peak over time
1 secondary outcome
Psychological Questionnaires
Time frame: Baseline, 12 weeks and 24 weeks
Results and safety
The study was stopped early (reason given: Recruitment Completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Background: PubMed 24708570Jakobsen MD, Sundstrup E, Brandt M, Kristensen AZ, Jay K, Stelter R, Lavendt E, Aagaard P, Andersen LL. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 7;15:119. doi: 10.1186/1471-2474-15-119.
- Background: PubMed 24467802van Berkel J, Boot CR, Proper KI, Bongers PM, van der Beek AJ. Effectiveness of a worksite mindfulness-based multi-component intervention on lifestyle behaviors. Int J Behav Nutr Phys Act. 2014 Jan 27;11:9. doi: 10.1186/1479-5868-11-9.
- Background: PubMed 15214603Marshall AL. Challenges and opportunities for promoting physical activity in the workplace. J Sci Med Sport. 2004 Apr;7(1 Suppl):60-6. doi: 10.1016/s1440-2440(04)80279-2.
- Individual participant dataSharing planned: No. Data is analyzed as group data
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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.
Shalini Moonsammy Persaud, PhD (cand) principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Health Coaching and Meditation and Exercise and Health Coaching in people with Motor Activity, run by York University at 1 site in Canada.
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 6 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: stopped early, as of the sponsor's last update on 6 Jan 2020. 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 Canada. 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 was stopped early (reason given: Recruitment Completed). Results are not available in the source record.
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?
VO2 Peak (time frame: Baseline, 12 weeks and 24 weeks). 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 NCT02936726, 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 6 Jan 2020.