- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05557071
Increasing Physical Activity Among Early Career Professionals: A Feasibility Trial of an Online Intervention
Physical activity promotion remains a public health priority and accessible and scalable interventions are needed. Early career professionals are at-risk for inactivity and therefore a critical target for physical activity promotion. An online delivery format made up of web-based lessons and podcasts meets accessibility needs for this time-pressed population and has strong potential for reach.
This study explores the feasibility of a theory-based intervention which accounts for action control, namely by leveraging the the Multi-Process Action Control framework (M-PAC) and targeting factors such as incidental affect (e.g., work-related stress) through emotion regulation strategies grounded in the principles of Acceptance and Commitment Therapy.
The primary objective of this study is to examine the feasibility and acceptability of a 6-week web-based physical activity behaviour change program for early career professionals. Primary outcomes include rates of recruitment, attention, adherence as well as study satisfaction and intervention acceptability. Secondary measures will include physical activity and emotion regulation. Additional measures will explore Multi-Process Action Control constructs, perceived stress, applied mindfulness, action and acceptance, and valued living.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND
Despite the well-established physical and psychological benefit of physical activity, much of the population is not meeting recommended guidelines. Critical life transitions have been linked to physical activity decline and it follows that targeting those in transition is prudent. Early career professionals are one such critical demographic. Given the stress, demands, and time constraints that come with shifting to the workforce, it can be difficult to follow through on physical activity intentions. As such, an intervention designed to incorporate intention translation, mitigate incidental affect, and foster emotion regulation is warranted. This study will examine the feasibility of an accessible online intervention. Qualitative analysis will assist with refining the intervention and the protocol. Progression criteria will be used to determine whether revisions should be considered before proceeding to a definitive randomized controlled trial.
TARGET POPULATION
Early career professionals, operationalized as adults aged 25-44 and working at a desk-based job.
DESIGN
An open parallel feasibility randomized controlled trial will compare an online intervention condition to a waitlist control condition. This study features a controlled baseline with a post-intervention (6 weeks) evaluative design with an embedded qualitative and quantitative process evaluation.
INTERVENTION
Participants will be randomized to 1) a waitlist control group and 2) and Online Platform Intervention group.
Condition one: Waitlist control group representing the comparator. The control group will complete the baseline and final questionnaires. Following study completion, this group has the option of gaining access to the online platform for their own benefit.
Condition two: Intervention group. Those in the intervention condition will gain access to the online platform after completing a baseline questionnaire. Participants will engage in a self-guided 6 week program made up of weekly lessons. A 'booster session' will be offered at 3 weeks to check in regarding progress and engagement. A follow-up survey will be completed at 6 weeks, post-intervention. Participants will be invited to complete a qualitative semi-structured exit interview following final questionnaire completion.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Victoria, British Columbia, Canada, V8P 5C2
- University of Victoria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English speaking adults, aged 25-44, living in Canada, currently employed at least part-time in a desk-based job, currently not meeting physical activity guidelines, no contraindications to safely increase physical activity, access to the internet and a device to support the e-health application
- Report no contraindications to physical activity (based on the completion of the Physical Activity Readiness Questionnaire administered at screening)
Exclusion Criteria:
- No internet access, unable to speak/read English, meeting physical activity guidelines, existing chronic medical condition making them at risk of injury or ill health from increased physical activity
- No exclusion criteria for sex, gender, medications, race or religion will be applied.
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
An online, asynchronous, self-paced, 6-week long, physical activity intervention.
|
Participants will gain access to 6 weekly lessons. A series of 6 weekly educational modules including information on psychosocial determinants of physical activity engagement, adherence and maintenance, as well as corresponding behaviour change techniques and a number of other tools and strategies, such as reflection activities, quizzes, and worksheets. Mini podcasts are available to supplement the concepts introduced in the modules. The content is tailored for early career professionals. There will be an emphasis on tactics (e.g., mindfulness, acceptance, emotion regulation) to assist with overcoming incidental affect. |
|
No Intervention: Control
A waitlist control; continue with life/activity as usual.
Control participants will receive access to the intervention at 6 weeks following all measurements.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment rate (monthly)
Time Frame: 4 months (at study completion)
|
Primary outcome related to trial feasibility
|
4 months (at study completion)
|
|
Participant retention
Time Frame: 6 weeks
|
Primary outcome related to trial feasibility
|
6 weeks
|
|
Adherence and engagement
Time Frame: 6 Weeks
|
Primary outcome related to trial feasibility
|
6 Weeks
|
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Study satisfaction and acceptabiity
Time Frame: 6 Weeks
|
Primary outcome related to trial acceptability
|
6 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported physical activity
Time Frame: 6 weeks
|
measured using the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
|
6 weeks
|
|
Emotion regulation
Time Frame: 6 weeks
|
Adapted from DERS-16 (Bjureberg et al., 2016)
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multi-Process Action Control constructs
Time Frame: 6 weeks
|
Exploratory outcomes and manipulation checks
|
6 weeks
|
|
ACT Constructs
Time Frame: 6 weeks
|
Exploratory outcomes and manipulation checks
|
6 weeks
|
|
Applied Mindfulness
Time Frame: 6 weeks
|
Exploratory outcomes and manipulation checks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Stina J Grant, BA, University of Victoria
- Principal Investigator: Ryan E Rhodes, PhD, University of Victoria
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20-0412
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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