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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02785107
Other study ID # 14-306
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received May 11, 2016
Last updated May 29, 2016
Start date January 2015
Est. completion date May 2015

Study information

Verified date May 2016
Source University of Victoria
Contact n/a
Is FDA regulated No
Health authority Canada: Human Research Ethics, University of Victoria
Study type Interventional

Clinical Trial Summary

The promotion of physical activity (PA) is paramount to public health, yet interventions in the social cognitive tradition have yielded negligible improvements. Two reasons for these results may be the over reliance on intention as the proximal determinant of behaviour and a lack of consideration of implicit/automatic determinants of PA. The purpose of this study was to apply Multi-Process Action Control (M-PAC), a framework centered on PA intention-translation and the gradual building of habit to examine PA change using a two-arm parallel design, randomized controlled trial.


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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- New gym member

- age 18-65

- Par-Q pass

Exclusion Criteria:

- age <18 or 65+

- Par-Q fail

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
M-PAC Group
Participants attended a workshop, completed a worksheet and received a booster phone call follow-up at week four.

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 Environmental Cues (self report, survey question) 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 No
Other Temporal Consistency (self report, survey question) 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 No
Primary GT3X+ Actigraph Activity Monitors (for measuring physical activity) Participants wear accelerometers for one week at baseline and at week eight to record their physical activity. Baseline to week eight No
Secondary Self-Report Behavioural Automaticity Index (self report, survey question) 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''. Baseline, week four, week eight No
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