- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02785107
Exercise Habit and M-PAC
Facilitating an Exercise Habit Via the Multi-Process Action Control Model: A Randomized-Controlled Trial
Study Overview
Detailed Description
Background: Two of the most prominent limitations of traditional social cognitive models used to understand moderate-to-vigorous physical activity (MVPA) are the gap between intention and behaviour and the lack of consideration of implicit processes in behavioural enactment. Thus, new models are now being examined that attempt to consider these potential limitations. Multi-Process Action Control (M-PAC) is one such attempt to build a more comprehensive schematic, whereby intention is established via the means of constructs from traditional social cognitive theories (i.e., outcome expectations, perceived capability), but the success of translating this intention to behaviour depends on behavioural-regulation (self-regulatory tactics) (BR), affective judgments (expected pleasure) (AJ) and opportunity (time, access). Over time, M-PAC proposes that habit (stimulus -behaviour bonds) and identity (role-behaviour bonds) develop from performing the behaviour and largely contribute to the maintenance of PA.
Aim: The purpose of this study was to conduct at two-arm parallel design, RCT to determine if the M-PAC experimental group would demonstrate greater change in PA and post-intention constructs across time.
Methods: Participants (n=94) were inactive new gym members and were randomized into a control or M-PAC experimental group. The experimental group attended a workshop and received a booster phone call follow-up at week four. Measures for both groups included accelerometry and M-PAC at baseline and at week eight.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
British Columbia
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Victoria, British Columbia, Canada, V8W 2Y2
- University of Victoria
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- New gym member
- age 18-65
- Par-Q pass
Exclusion Criteria:
- age <18 or 65+
- Par-Q fail
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention
Those who were randomized into the intervention group attended a workshop where the PI delivered a presentation that focused on establishing a preparatory exercise habit by using the M-PAC approach and proposed habit model.
Participants were then provided with instructions on completing their exercise plan sheet.
|
Participants attended a workshop, completed a worksheet and received a booster phone call follow-up at week four.
|
|
NO_INTERVENTION: Control
Participants exercised on their own without receiving any instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GT3X+ Actigraph Activity Monitors (for measuring physical activity)
Time Frame: Baseline to week eight
|
Participants wear accelerometers for one week at baseline and at week eight to record their physical activity.
|
Baseline to week eight
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Report Behavioural Automaticity Index (self report, survey question)
Time Frame: Baseline, week four, week eight
|
The Self-Report Behavioral Automaticity Index (SRBAI) was used to assess preparatory habit.
The SRBAI consists of 4 items on a 5-point Likert scale with 1 being strongly disagree to 5 being strongly agree.
The question stem stated ''When I prepare to exercise…'' which was then followed by four items on the scale: ''I do it without having to consciously remember'', ''I do it automatically'', ''I do it without thinking'', and ''I start before I realize I am doing it''.
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Baseline, week four, week eight
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Environmental Cues (self report, survey question)
Time Frame: Baseline, week four, week eight
|
The following item was used to assess if participants implemented the use of cues: "I use cues at home to remind me to exercise (e.g.
placing a water bottle on my desk or gym clothes on the bed).
The item was rated on a five point Likert scale which ranged from "1=strongly disagree" to "5= strongly agree".
|
Baseline, week four, week eight
|
|
Temporal Consistency (self report, survey question)
Time Frame: Baseline, week four, week eight
|
The item was worded "How consistently do you exercise at the same time each day?
(e.g., exercising every morning at 7 am, or exercising daily after supper)".
The question was asked on a five point Likert scale which range from "1=not consistent at all" to "5=very consistent".
|
Baseline, week four, week eight
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Navin Kaushal, PhD, University of Victoria
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14-306
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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