Examining Exercise, Health Coaching and Meditation for University Employees

January 3, 2020 updated by: Shalini Moonsammy Persaud, York University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3J 1P3
        • York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Behavioral: Exercise and Health Coaching
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).
Behavioral: Exercise, Health Coaching and Meditation
Comparing Exercise, Health Coaching and Meditation In Combination

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
York University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shalini Moonsammy Persaud, PhD (cand), York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU 2016 - 121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data is analyzed as group data

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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