- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509061
"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
July 18, 2024 updated by: University of Manitoba
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PASD Intervention
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.
|
6 week behavioural change program designed to increase PASD and PA
|
|
Active Comparator: Attention Control
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.
|
6 week program designed to as an attention control, delivering content on general health behaviour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention
|
|
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)
|
Measured pre-intervention, 5 weeks later at intervention end and 4 weeks post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
September 1, 2015
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
June 28, 2024
First Submitted That Met QC Criteria
July 17, 2024
First Posted (Actual)
July 19, 2024
Study Record Updates
Last Update Posted (Actual)
July 22, 2024
Last Update Submitted That Met QC Criteria
July 18, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- E2013:120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We do not have ethics approval to share data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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