- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936726
Examining Exercise, Health Coaching and Meditation for University Employees
The Healthy Staff Initiative Study: Examining Exercise, Health Coaching and Meditation for University Employees: a Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M3J 1P3
- York University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Employees at York University;
- fluency in English;
- provision of informed consent
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise and Health Coaching
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) |
Comparing Exercise and Health Coaching Alone
|
|
Experimental: Exercise, Health Coaching and Meditation
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). |
Comparing Exercise, Health Coaching and Meditation In Combination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO2 Peak
Time Frame: Baseline, 12 weeks and 24 weeks
|
Assess changes in VO2 peak over time
|
Baseline, 12 weeks and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Questionnaires
Time Frame: Baseline, 12 weeks and 24 weeks
|
Assess changes over time
|
Baseline, 12 weeks and 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shalini Moonsammy Persaud, PhD (cand), York University
Publications and helpful links
General 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.
- van 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.
- Marshall 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU 2016 - 121
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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