Public HealthPhase 2/3NCT02785107
Exercise Habit and M-PAC
A Phase 2/3 study testing M-PAC Group in people with Public Health, run by University of Victoria at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Public Health
- What is being tested?
- M-PAC Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to May 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New gym member
- age 18-65
- Par-Q pass
Who cannot join
- age <18 or 65+
- Par-Q fail
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facilitating an Exercise Habit Via the Multi-Process Action Control Model: A Randomized-Controlled Trial
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.
Read the 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.
- Conditions
- Public Health
- Being tested
- M-PAC Group
- Keywords
- Exercise, Habit, MVPA, M-PAC, Automaticity, Physical Activity
- Medical subject headings
- Motor Activity, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-PAC GroupBehavioural
Participants attended a workshop, completed a worksheet and received a booster phone call follow-up at week four.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: M-PAC Group |
| Control | No intervention | Participants exercised on their own without receiving any instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week eight
Secondary outcomes (1)
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''.
Measured: Baseline, week four, week eight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Public HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Victoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navin Kaushal, University of Victoria
- Investigators
- Navin Kaushal, PhD, Principal investigator, University of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785107
- Sponsor's protocol ID
- 14-306
- Status last verified
- May 2016
- First submitted
- 11 May 2016
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kaushal N, Rhodes RE, Spence JC, Meldrum JT. Increasing Physical Activity Through Principles of Habit Formation in New Gym Members: a Randomized Controlled Trial. Ann Behav Med. 2017 Aug;51(4):578-586. doi: 10.1007/s12160-017-9881-5.
PubMed 28188586
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating an Exercise Habit Via the Multi-Process Action Control Model: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT02785107
- Acronym / sponsor ID
- 14-306
- Conditions
- Public Health
- Keywords
- Exercise, Habit, MVPA, M-PAC, Automaticity, Physical Activity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of VictoriaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: M-PAC GroupThose 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. |
| Control | No intervention | –Participants exercised on their own without receiving any instructions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New gym member
- age 18-65
- Par-Q pass
Key exclusion criteria (2 listed)
- age <18 or 65+
- Par-Q fail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-PAC GroupParticipants attended a workshop, completed a worksheet and received a booster phone call follow-up at week four. | Behavioural | Intervention |
Primary outcome
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.
1 secondary outcome
Self-Report Behavioural Automaticity Index (self report, survey question)
Time frame: Baseline, week four, week eight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
- Derived from this study: PubMed 28188586Kaushal N, Rhodes RE, Spence JC, Meldrum JT. Increasing Physical Activity Through Principles of Habit Formation in New Gym Members: a Randomized Controlled Trial. Ann Behav Med. 2017 Aug;51(4):578-586. doi: 10.1007/s12160-017-9881-5.
- Individual participant dataSharing planned: No
Related trials for Public Health
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Not yet recruitingObservational study
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
Malaria
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Active, not recruiting
Conquering Hypertension in Urban Vietnam
Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navin Kaushal, PhD principal investigator
University of Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing M-PAC Group in people with Public Health, run by University of Victoria at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GT3X+ Actigraph Activity Monitors (for measuring physical activity) (time frame: Baseline to week eight). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.