Trial record 2 of 8 for:    ambition

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Hallgeir Halvari, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier:
NCT02429635
First received: April 14, 2015
Last updated: April 28, 2015
Last verified: April 2015
  Purpose

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?

Condition Intervention Phase
Inactivity/Low Levels of Exercise
Behavioral: My exercise
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Workplace Health and Wellness Promotion: Investigating the Effects of a Team-based Intervention on Individual Motivation and Enhanced Physical Activity, Health and Work-functioning

Resource links provided by NLM:


Further study details as provided by Norwegian School of Sport Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assessed by a self reported questionnaire: International Physical Activity Index (IPAI). (Kurtze et al., 2008)

  • Changes from baseline cardiovascular endurance/aerobic fitness (Astrand-Rhyming Cycle Ergometer Test) [ Time Frame: T1: baseline, T2: Post-test 5 months ] [ Designated as safety issue: No ]
    Assessed by Astrand-Rhyming Cycle Ergometer Test. This ia submaximal cycle ergometer aerobic fitness test (Astrand, 1960).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Changes will be measured manually by means of an auscultatory technique with a mercury column or mechanical aneroid sphygmomanometer.

  • Changes from baseline body weight and composition (Tanita Scale) [ Time Frame: T1: baseline, T2: post-test 5 months ] [ Designated as safety issue: No ]
    Tanita Scale - Body Composition Tracking Charts, Body Mass Index (BMI) (Keys et al., 1972), and waist circumference

  • 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 ] [ Designated as safety issue: No ]
    Assessed by a self-reporting questionnaire Behavioral Regulation in Exercise Questionnaire (BREQ-2), Mullan et al.(1997)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire:The Basic Psychological Needs in Exercise Scale (BPNES) Vlachopoulos and Michailidou (2006)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: Self-efficacy in Exercise Scale, Fuchs and Schwarzer (1994)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: Perceived Competence for Exercise Scale, Williams and Deci (1996)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: Effort and Quality of Work, Kuvaas(2006)

  • Changes from baseline turnover intentions (Current Turnover Intentions) [ Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months ] [ Designated as safety issue: No ]
    Assessed by two self-reporting questionnaires: Current Turnover Intentions(O'Driscoll and Beehr, 1994) and Past Year Turnover Intentions (Luchak and Gellatly, 2007)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire Organizational Commitment, Affective Commitment Sub-scale, Allen and Meyer (1990)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: Perceived investment in employee development (PIED) adjusted to health competence, Kuvaas and Dysvik (2009)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by two self-reporting questionnaires: Satisfaction in Life Scale, Pavot and Diener (1993), and Subjective Vitality, Ryan and Frederick (1997)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: Positive and Negative Affect Scale (PANAS) Watson et al. (1988)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: The Somatic Symptom Scale (SSS-8), Gierk et al. (2014)

  • Changes from baseline sickness absence and presenteeism [ Time Frame: T1: baseline, T2: post-test 5 months, T3: post-test 8 months ] [ Designated as safety issue: No ]
    Assesses by self-reporting questionnaire: Sickness absence and presenteeism, Aronsson and Lindh (2004)

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: The Health Care Climate Questionnaire (HCCQ), Williams et al., 1996

  • 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 ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: The Health Care Climate Questionnaire (HCCQ) adjusted to work peers, Williams et al., 1996.

  • Changes from baseline sickness absence [ Time Frame: T1: baseline, T2: post-test 5 months ] [ Designated as safety issue: No ]
    Assessed by self-reporting questionnaire: Sickness absence and presenteeism, Aronsson and Lindh, 2004.


Estimated Enrollment: 240
Study Start Date: January 2015
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: A team-based health promotion intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Temporary employment that lasts for less than 12 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02429635

Locations
Norway
Norwegian School of Sport Science
Oslo, Norway, 0863
Sponsors and Collaborators
Norwegian School of Sport Sciences
The Research Council of Norway
Investigators
Study Chair: Hallgeir Halvari, Professor Norwegian School of Sport Sciences
  More Information

Responsible Party: Hallgeir Halvari, Professor II, Norwegian School of Sport Sciences
ClinicalTrials.gov Identifier: NCT02429635     History of Changes
Other Study ID Numbers: 2013/294  227874 
Study First Received: April 14, 2015
Last Updated: April 28, 2015
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian School of Sport Sciences:
Exercise
lifestyle diseases
well-being

ClinicalTrials.gov processed this record on July 21, 2016