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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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date June 30, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Digital Health Behaviour Change Platform
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.

Locations

Country Name City State
Canada University of Victoria Victoria British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of Victoria

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Multi-Process Action Control constructs Exploratory outcomes and manipulation checks 6 weeks
Other ACT Constructs Exploratory outcomes and manipulation checks 6 weeks
Other Applied Mindfulness Exploratory outcomes and manipulation checks 6 weeks
Primary Recruitment rate (monthly) Primary outcome related to trial feasibility 4 months (at study completion)
Primary Participant retention Primary outcome related to trial feasibility 6 weeks
Primary Adherence and engagement Primary outcome related to trial feasibility 6 Weeks
Primary Study satisfaction and acceptabiity Primary outcome related to trial acceptability 6 Weeks
Secondary Self-reported physical activity measured using the Godin Leisure-Time Exercise Questionnaire (GLTEQ) 6 weeks
Secondary Emotion regulation Adapted from DERS-16 (Bjureberg et al., 2016) 6 weeks
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