Physical Activity Self-DefinitionNCT06509061
"I am a Physically Active Person!": A Randomized Controlled Trial Aimed to Increase Levels of Physical Activity Self-Definition and Physical Activity Among a Sample of Inactive Adults
A study testing Physical Activity Self-Definition in people with Physical Activity Self-Definition and Physical Activity, run by University of Manitoba.
Trial summary
This explanatory sequential mixed methods study investigated if an intervention can increase the physical activity identity and physical activity (PA) of inactive individuals. The intervention condition focused on increasing participant's physical activity self-definition (PASD) through educational sessions and group… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity Self-Definition, Physical Activity
- What is being tested?
- Physical Activity Self-Definition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Apr 2017
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be insufficiently active (<150 minutes of moderate-vigorous PA per week)
- Scored below the mean in PASD
- Medically safe to participate in PA
- Intention to engage in PA over the next 6 weeks
Who cannot join
None listed.
About this study
This explanatory sequential mixed methods study investigated if an intervention can increase the physical activity identity and physical activity (PA) of inactive individuals. The intervention condition focused on increasing participant's physical activity self-definition (PASD) through educational sessions and group discussions on the five direct and indirect determinants of PASD (perceived enjoyment, perceived wanting, perceived commitment, perceived trying, perceived ability). The control condition was given general health behaviour education sessions. Researchers conducted interviews with some of the participants after the intervention was completed.
- Being tested
- Physical Activity Self-Definition, Control
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Self-DefinitionOther
6 week behavioural change program designed to increase PASD and PA
ControlOther
6 week program designed to as an attention control, delivering content on general health behaviour.
| Study group | Role | What they receive |
|---|---|---|
| PASD Intervention | Experimental | 6 week 30-45 minute psychoeducation sessions that delivered content on the variables within the Physical Activity Self-Definition Model. The first session was an introductory session and each one that followed focused on one of the direct or indirect determinants of the model: perceived enjoyment, perceived wanting, perceived commitment, perceived trying, perceived ability (all relating to physical activity). Group activities such as worksheets and discussion were carried out during the session. Receives: Other: Physical Activity Self-Definition |
| Attention Control | Active comparator | 6 week 30-45 minute educational sessions that delivered content on general health behaviour. After the introductory session, each week, one of five general health behaviours were covered: balanced diet, sleep, reducing sedentary behaviour, mental/spiritual health and self-compassion/cultivating positive health behaviours. Group activities such as worksheets and discussion were carried out during the session. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Self-Definition
Measured with a 4-item questionnaire using a 7-point Likert scale (1= strongly disagree; 7 = strongly agree)
Measured: Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention
ActiGraph Accelerometers
Weekly sedentary, light, moderate, and vigorous physical activity minutes were measured using accelerometers, worn at the hip for 7 day during waking hours.
Measured: Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study startSep 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Activity Self-DefinitionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Research Manitoba
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509061
- Sponsor's protocol ID
- E2013:120
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have ethics approval to share data
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "I am a Physically Active Person!": A Randomized Controlled Trial Aimed to Increase Levels of Physical Activity Self-Definition and Physical Activity Among a Sample of Inactive Adults
- ClinicalTrials.gov ID
- NCT06509061
- Acronym / sponsor ID
- E2013:120
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Research Manitoba
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Jul 2024 (actual)
- 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.
This explanatory sequential mixed methods study investigated if an intervention can increase the physical activity identity and physical activity (PA) of inactive individuals. The intervention condition focused on increasing participant's physical activity self-definition (PASD) through educational sessions and group discussions on the five direct and indirect determinants of PASD (perceived enjoyment, perceived wanting, perceived commitment, perceived trying, perceived ability). The control condition was given general health behaviour education sessions. Researchers conducted interviews with some of the participants after the intervention was completed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PASD Intervention | Experimental | Other: Physical Activity Self-Definition6 week 30-45 minute psychoeducation sessions that delivered content on the variables within the Physical Activity Self-Definition Model. The first session was an introductory session and each one that followed focused on one of the direct or indirect determinants of the model: perceived enjoyment, perceived wanting, perceived commitment, perceived trying, perceived ability (all relating to physical activity). Group activities such as worksheets and discussion were carried out during the session. |
| Attention Control | Active comparator | Other: Control6 week 30-45 minute educational sessions that delivered content on general health behaviour. After the introductory session, each week, one of five general health behaviours were covered: balanced diet, sleep, reducing sedentary behaviour, mental/spiritual health and self-compassion/cultivating positive health behaviours. Group activities such as worksheets and discussion were carried out during the session. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must be insufficiently active (<150 minutes of moderate-vigorous PA per week)
- Scored below the mean in PASD
- Medically safe to participate in PA
- Intention to engage in PA over the next 6 weeks
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Physical Activity Self-Definition6 week behavioural change program designed to increase PASD and PA | Other | PASD Intervention |
| Control6 week program designed to as an attention control, delivering content on general health behaviour. | Other | Attention Control |
Primary outcome
Physical Activity Self-Definition
Time frame: Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention
Measured with a 4-item questionnaire using a 7-point Likert scale (1= strongly disagree; 7 = strongly agree)
ActiGraph Accelerometers
Time frame: Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention
Weekly sedentary, light, moderate, and vigorous physical activity minutes were measured using accelerometers, worn at the hip for 7 day during waking hours.
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 22 Jul 2024.
- Individual participant dataSharing planned: No. We do not have ethics approval to share data
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Self-Definition in people with Physical Activity Self-Definition and Physical Activity, run by University of Manitoba.
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 4 inclusion and 0 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 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Physical Activity Self-Definition (time frame: Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention). 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?
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 22 Jul 2024.