Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05557071 |
Other study ID # |
20-0412 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 18, 2022 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
August 2023 |
Source |
University of Victoria |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
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.