My Exercise. A Team-based Workplace Intervention for Increased Exercise (Myexercise)

September 18, 2017 updated by: Hallgeir Halvari, Norwegian School of Sport Sciences

Workplace Health and Wellness Promotion: Investigating the Effects of a Team-based Intervention on Individual Motivation and Enhanced Physical Activity, Health and Work-functioning

The aim of this research study is to assess the effectiveness of an intervention on exercise and health, and to contribute to the understanding of how team-based worksite health promotion programs should be designed in order to increase and maintain exercise among employees. The study design is a randomized controlled trial.

There are a number of different theories on the subject of how to affect motivation for health behavior change. This study is based on the tenets of Self-Determination Theory (SDT) in combination with elements from Motivational Interviewing and in accordance with the Health Promotion Guidelines developed by the National Institute of Health and Clinical Excellence, NICE.

It is assumed that if such a program is designed and offered in a manner that satisfies the participants' sense of autonomy, competence and relatedness, this will affect the quality of the participants' self-regulated motivation and perceived competence for exercise and lifestyle changes. As a consequence, a large proportion of the participants will adhere to the program and increase their exercise both in the short (5 months) and long term (8 months).

The following research questions will be:

  1. Would a team-based health and exercise promotion intervention designed to be needs supportive, relative to a control group:

    1. Influence increases in exercise levels, improved aerobic fitness, reduced blood pressure, and decreases in waist circumference, and Body mass index (BMI), in addition to changes in body composition in terms of reduced percentage of fat and increased percentage of muscles?
    2. Influence increases in psychological well-being?
    3. Influence increases in perceived investment in employees' health competence, which would positively predict affective organizational commitment and job performance, and negatively predict turnover intentions?
    4. Influence decreases in sickness absenteeism?
  2. If so, would changes in psychological needs support, autonomous motivation for exercise, perceived competence and self-efficacy in exercise mediate these effects?

Study Overview

Status

Status

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

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

The principal contribution of this study is the understanding of whether and how a SDT-based intervention affects the participants' degree of autonomous motivation and perceived competence for exercise, and as a consequence behavioral change in the form of increased and regular exercise. That is, the psycho-social processes which are unfolding during the intervention, and caused by the intervention.

The intervention is implemented in a worksite setting and connected to a team-based health promotion program.

This is a cluster-randomized two-group trial that compares a group-based intervention with a control group. Cluster-randomization will be carried out at the level of physical location consisting of two work teams each.

Pre- and post-test assessments will be carried out during an individual health screening consisting of physiological tests and cross-sectional data collection in the form of quantitative and standardized questionnaires. The results are compiled in a health profile report. Participants are offered a 15-20 minutes individual consultation with the professional health advisor in order to explain the findings, answer quesdtions and giving healht recommendations.

A small collection of the questionnaires and some qualitative interviews will be applied in order to collect data on relevant variables during the intervention period as well as to assess fidelity and participants' perceptions of the intervention.

The intervention consists of three elements; two team-workshops, exercise support group meetings and a workbook for self-reflection and planning. The intervention will be carried out by two health advisors professionals (physiotherapist) trained in order to facilitate and lead the team-workshops in a need supportive manner.

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.
202

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

  • Norway
      • Oslo, Norway, 0863
        • Norwegian School of Sport Science

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 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Employment at the Norwegian Post
  • Position of 40% or more

Exclusion Criteria:

  • Temporary employment that lasts for less than 12 months

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: Prevention
  • 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.
Experimental: My exercise

Health Screening I and II Questionnaires on health and lifestyle, physiological test of fitness, physiological health tests and blood profile - compiled in a health profile report. Individual guidance and advice from professional health advisor.

Team-workshop I and II A 2 hours' workshop lead and facilitated by a trained and professional health advisor. It consists of short talks on exercise and health, and on health behavior change and motivation in addition to work with self-reflection and discussion tasks. Competence, support and advice during 2. workshp.

Exercise groups Small groups with similar exercise level and ambitions who support each other in their efforts to establish new exercise habits according to their individual exercise plan.
Behavioral: My exercise

Health Screening I and II Questionnaires on health and lifestyle, physiological test of fitness, physiological health tests and blood profile - compiled in a health profile report. Individual guidance and advice from professional health advisor.

Team-workshop I and II A 2 hours' workshop lead and facilitated by a trained and professional health advisor. It consists of short talks on exercise and health, and on health behavior change and motivation in addition to work with self-reflection and discussion tasks. Competence, support and advice during 2. workshop.

Exercise groups Small groups with similar exercise level and ambitions who support each other in their efforts to establish new exercise habits according to their individual exercise plan

Other Names:
  • A team-based health promotion intervention
Experimental: Control group - delayed intervention

Health Screening I and II Questionnaires on health and lifestyle, physiological test of fitness, physiological health tests and blood profile - compiled in a health profile report. Individual guidance and advice from professional health advisor.

Team workshops and training groups The control groups will consist of teams that will receive the team-based health promotion measures about 9 months after the Team-based health promotion measures group.
Behavioral: My exercise

Health Screening I and II Questionnaires on health and lifestyle, physiological test of fitness, physiological health tests and blood profile - compiled in a health profile report. Individual guidance and advice from professional health advisor.

Team-workshop I and II A 2 hours' workshop lead and facilitated by a trained and professional health advisor. It consists of short talks on exercise and health, and on health behavior change and motivation in addition to work with self-reflection and discussion tasks. Competence, support and advice during 2. workshop.

Exercise groups Small groups with similar exercise level and ambitions who support each other in their efforts to establish new exercise habits according to their individual exercise plan

Other Names:
  • A team-based health promotion intervention

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
Changes from baseline levels of regular exercise (International Physical Activity Index (IPAI)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by a self reported questionnaire: International Physical Activity Index (IPAI). (Kurtze et al., 2008)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline cardiovascular endurance/aerobic fitness (Astrand-Rhyming Cycle Ergometer Test)
Time Frame: T1: baseline, T2: Post-test 5 months
Assessed by Astrand-Rhyming Cycle Ergometer Test. This ia submaximal cycle ergometer aerobic fitness test (Astrand, 1960).
T1: baseline, T2: Post-test 5 months

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
Changes from baseline Systolic Blood Pressure (measured manually by means of an auscultatory technique with a mercury column or mechanical aneroid sphygmomanometer)
Time Frame: T1: baseline, T2: Post-test 5 months
Changes will be measured manually by means of an auscultatory technique with a mercury column or mechanical aneroid sphygmomanometer.
T1: baseline, T2: Post-test 5 months
Changes from baseline body weight and composition (Tanita Scale)
Time Frame: T1: baseline, T2: post-test 5 months
Tanita Scale - Body Composition Tracking Charts, Body Mass Index (BMI) (Keys et al., 1972), and waist circumference
T1: baseline, T2: post-test 5 months
Changes from baseline self-regulated motivation for exercise (Behavioral Regulation in Exercise Questionnaire (BREQ-2)
Time Frame: T1: Prbaseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by a self-reporting questionnaire Behavioral Regulation in Exercise Questionnaire (BREQ-2), Mullan et al.(1997)
T1: Prbaseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline basic psychological needs satisfaction in exercise (Basic Psychological Needs in Exercise Scale (BPNES)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire:The Basic Psychological Needs in Exercise Scale (BPNES) Vlachopoulos and Michailidou (2006)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline perceived self-efficacy in exercise (Self-efficacy in Exercise Scale)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire: Self-efficacy in Exercise Scale, Fuchs and Schwarzer (1994)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline perceived competence for exercise (Perceived Competence for Exercise Scale)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire: Perceived Competence for Exercise Scale, Williams and Deci (1996)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline perceived work effort and work performance (Effort and Quality of Work)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire: Effort and Quality of Work, Kuvaas(2006)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline turnover intentions (Current Turnover Intentions)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by two self-reporting questionnaires: Current Turnover Intentions(O'Driscoll and Beehr, 1994) and Past Year Turnover Intentions (Luchak and Gellatly, 2007)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline attitutes towards work and employer, affective commitment (Organizational Commitment, Affective Commitment Sub-scale)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire Organizational Commitment, Affective Commitment Sub-scale, Allen and Meyer (1990)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline perceived investment in health competence by employer (Perceived investment in employee development (PIED) adjusted to health competence)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire: Perceived investment in employee development (PIED) adjusted to health competence, Kuvaas and Dysvik (2009)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline satisfaction with life and well-being in general (Satisfaction in Life Scale, and Subjective Vitality)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by two self-reporting questionnaires: Satisfaction in Life Scale, Pavot and Diener (1993), and Subjective Vitality, Ryan and Frederick (1997)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline positive and negative affect (Positive and Negative Affect Scale (PANAS)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire: Positive and Negative Affect Scale (PANAS) Watson et al. (1988)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline somatic symptoms burden (Somatic Symptom Scale (SSS-8)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire: The Somatic Symptom Scale (SSS-8), Gierk et al. (2014)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline sickness absence and presenteeism
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assesses by self-reporting questionnaire: Sickness absence and presenteeism, Aronsson and Lindh (2004)
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline perceived support from work peers related to exercise (The Health Care Climate Questionnaire (HCCQ)
Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Assessed by self-reporting questionnaire: The Health Care Climate Questionnaire (HCCQ), Williams et al., 1996
T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline perceived support form work peers related to exercise (The Health Care Climate Questionnaire (HCCQ) adjusted to work peers)
Time Frame: T1: baseline, T2: post-test 5 months
Assessed by self-reporting questionnaire: The Health Care Climate Questionnaire (HCCQ) adjusted to work peers, Williams et al., 1996.
T1: baseline, T2: post-test 5 months
Changes from baseline sickness absence
Time Frame: T1: baseline, T2: post-test 5 months
Assessed by self-reporting questionnaire: Sickness absence and presenteeism, Aronsson and Lindh, 2004.
T1: baseline, T2: post-test 5 months

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.
Norwegian School of Sport Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Research Council of Norway

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.
  • Study Chair: Hallgeir Halvari, Professor, Norwegian School of Sport Sciences

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.
January 1, 2015

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.
April 1, 2016

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.
April 1, 2016

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).
April 14, 2015

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.
April 28, 2015

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.
April 29, 2015

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.
September 19, 2017

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.
September 18, 2017

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.
September 1, 2017

More Information

Terms related to this study

Keywords

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.
  • 2013/294
  • 227874 (Other Grant/Funding Number: The Research Counsil of Norway)

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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