NCT02936726

Brief 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. 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

October 12, 2016

Last Update Submit

January 3, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • VO2 Peak

    Assess changes in VO2 peak over time

    Baseline, 12 weeks and 24 weeks

Secondary Outcomes (1)

  • Psychological Questionnaires

    Baseline, 12 weeks and 24 weeks

Study Arms (2)

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)

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).

Behavioral: Exercise, Health Coaching and Meditation

Interventions

Comparing Exercise, Health Coaching and Meditation In Combination

Exercise, Health Coaching and Meditation

Comparing Exercise and Health Coaching Alone

Exercise and Health Coaching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employees at York University;
  • fluency in English;
  • provision of informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

Related Publications (3)

  • 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.

    PMID: 24708570BACKGROUND
  • 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.

    PMID: 24467802BACKGROUND
  • 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.

    PMID: 15214603BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseMeditation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Shalini Moonsammy Persaud, PhD (cand)

    York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Canditate

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 18, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Data is analyzed as group data

Locations