Inactivity/Low Levels of ExerciseMyexerciseNCT02429635
My Exercise. A Team-based Workplace Intervention for Increased Exercise
A study testing My exercise in people with Inactivity/Low Levels of Exercise, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Inactivity/Low Levels of Exercise
- What is being tested?
- My exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employment at the Norwegian Post
- Position of 40% or more
Who cannot join
- Temporary employment that lasts for less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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:
- Would a team-based health and exercise promotion intervention designed to be needs supportive, relative to a control group:
- 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?
- Influence increases in psychological well-being?
- Influence increases in perceived investment in employees' health competence, which would positively predict affective organizational commitment and job performance, and negatively predict turnover intentions?
- Influence decreases in sickness absenteeism?
- If so, would changes in psychological needs support, autonomous motivation for exercise, perceived competence and self-efficacy in exercise mediate these effects?
Read the 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.
- Conditions
- Inactivity/Low Levels of Exercise
- Being tested
- My exercise
- Keywords
- Exercise, lifestyle diseases, well-being
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My exerciseBehavioural
Also called A team-based health promotion 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-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
| Study group | Role | What they receive |
|---|---|---|
| My exercise | Experimental | 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. Receives: Behavioral: My exercise |
| Control group - delayed intervention | Experimental | 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. Receives: Behavioral: My exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline levels of regular exercise (International Physical Activity Index (IPAI)
Assessed by a self reported questionnaire: International Physical Activity Index (IPAI). (Kurtze et al., 2008)
Measured: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline cardiovascular endurance/aerobic fitness (Astrand-Rhyming Cycle Ergometer Test)
Assessed by Astrand-Rhyming Cycle Ergometer Test. This ia submaximal cycle ergometer aerobic fitness test (Astrand, 1960).
Measured: T1: baseline, T2: Post-test 5 months
Secondary outcomes (17)
Changes from baseline Systolic Blood Pressure (measured manually by means of an auscultatory technique with a mercury column or mechanical aneroid sphygmomanometer)
Changes will be measured manually by means of an auscultatory technique with a mercury column or mechanical aneroid sphygmomanometer.
Measured: T1: baseline, T2: Post-test 5 months
Changes from baseline body weight and composition (Tanita Scale)
Tanita Scale - Body Composition Tracking Charts, Body Mass Index (BMI) (Keys et al., 1972), and waist circumference
Measured: T1: baseline, T2: post-test 5 months
Changes from baseline self-regulated motivation for exercise (Behavioral Regulation in Exercise Questionnaire (BREQ-2)
Assessed by a self-reporting questionnaire Behavioral Regulation in Exercise Questionnaire (BREQ-2), Mullan et al.(1997)
Measured: 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)
Assessed by self-reporting questionnaire:The Basic Psychological Needs in Exercise Scale (BPNES) Vlachopoulos and Michailidou (2006)
Measured: 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)
Assessed by self-reporting questionnaire: Self-efficacy in Exercise Scale, Fuchs and Schwarzer (1994)
Measured: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline perceived competence for exercise (Perceived Competence for Exercise Scale)
Assessed by self-reporting questionnaire: Perceived Competence for Exercise Scale, Williams and Deci (1996)
Measured: 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)
Assessed by self-reporting questionnaire: Effort and Quality of Work, Kuvaas(2006)
Measured: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline turnover intentions (Current Turnover Intentions)
Assessed by two self-reporting questionnaires: Current Turnover Intentions(O'Driscoll and Beehr, 1994) and Past Year Turnover Intentions (Luchak and Gellatly, 2007)
Measured: 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)
Assessed by self-reporting questionnaire Organizational Commitment, Affective Commitment Sub-scale, Allen and Meyer (1990)
Measured: 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)
Assessed by self-reporting questionnaire: Perceived investment in employee development (PIED) adjusted to health competence, Kuvaas and Dysvik (2009)
Measured: 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)
Assessed by two self-reporting questionnaires: Satisfaction in Life Scale, Pavot and Diener (1993), and Subjective Vitality, Ryan and Frederick (1997)
Measured: 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)
Assessed by self-reporting questionnaire: Positive and Negative Affect Scale (PANAS) Watson et al. (1988)
Measured: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline somatic symptoms burden (Somatic Symptom Scale (SSS-8)
Assessed by self-reporting questionnaire: The Somatic Symptom Scale (SSS-8), Gierk et al. (2014)
Measured: T1: baseline, T2: post-test 5 months, T3: post-test 8 months
Changes from baseline sickness absence and presenteeism
Assesses by self-reporting questionnaire: Sickness absence and presenteeism, Aronsson and Lindh (2004)
Measured: 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)
Assessed by self-reporting questionnaire: The Health Care Climate Questionnaire (HCCQ), Williams et al., 1996
Measured: 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)
Assessed by self-reporting questionnaire: The Health Care Climate Questionnaire (HCCQ) adjusted to work peers, Williams et al., 1996.
Measured: T1: baseline, T2: post-test 5 months
Changes from baseline sickness absence
Assessed by self-reporting questionnaire: Sickness absence and presenteeism, Aronsson and Lindh, 2004.
Measured: T1: baseline, T2: post-test 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inactivity/Low Levels of ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Hallgeir Halvari, Norwegian School of Sport Sciences
- Investigators
- Hallgeir Halvari, Professor, Study chair, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429635
- Sponsor's protocol ID
- 2013/294
- Other IDs
- 227874
- Acronym
- Myexercise
- Status last verified
- Sep 2017
- First submitted
- 14 Apr 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pedersen C, Halvari H, Olafsen AH. Worksite physical activity intervention and somatic symptoms burden: The role of coworker support for basic psychological needs and autonomous motivation. J Occup Health Psychol. 2019 Feb;24(1):55-65. doi: 10.1037/ocp0000131. Epub 2018 Aug 16.
PubMed 30113178
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02429635
- Acronym / sponsor ID
- Myexercise / 2013/294
- Conditions
- Inactivity/Low Levels of Exercise
- Keywords
- Exercise, lifestyle diseases, well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Jan 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Would a team-based health and exercise promotion intervention designed to be needs supportive, relative to a control group:
- 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?
- Influence increases in psychological well-being?
- Influence increases in perceived investment in employees' health competence, which would positively predict affective organizational commitment and job performance, and negatively predict turnover intentions?
- Influence decreases in sickness absenteeism?
- If so, would changes in psychological needs support, autonomous motivation for exercise, perceived competence and self-efficacy in exercise mediate these effects?
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My exercise | Experimental | Behavioral: My exerciseHealth 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. |
| Control group - delayed intervention | Experimental | Behavioral: My exerciseHealth 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. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employment at the Norwegian Post
- Position of 40% or more
Key exclusion criteria (1 listed)
- Temporary employment that lasts for less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My exerciseAlso: A team-based health promotion interventionHealth 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 | Behavioural | Control group - delayed intervention, My exercise |
Primary outcome
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)
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).
17 secondary outcomes
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 from baseline body weight and composition (Tanita Scale)
Time frame: 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
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
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
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
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
Changes from baseline turnover intentions (Current Turnover Intentions)
Time frame: 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
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
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
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
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
Changes from baseline sickness absence and presenteeism
Time frame: 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
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
Changes from baseline sickness absence
Time frame: T1: baseline, T2: post-test 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Derived from this study: PubMed 30113178Pedersen C, Halvari H, Olafsen AH. Worksite physical activity intervention and somatic symptoms burden: The role of coworker support for basic psychological needs and autonomous motivation. J Occup Health Psychol. 2019 Feb;24(1):55-65. doi: 10.1037/ocp0000131. Epub 2018 Aug 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hallgeir Halvari, Professor study chair
Norwegian School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My exercise in people with Inactivity/Low Levels of Exercise, run by Norwegian School of Sport Sciences at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017; AzTrials last refreshed its copy on 27 Oct 2026.