- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03677687
Mindfulness for Physical Activity Research Project
February 26, 2019 updated by: Kat Schneider, Liverpool John Moores University
Adapting a Mindfulness-based Programme to Facilitate Physical Activity Uptake in Underactive Participants: A Feasibility Study
This study aims to evaluate the feasibility and preliminary effectiveness of a Mindfulness for Physical Activity programme on physical activity outcomes in underactive participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In recent years, mindfulness-based approaches have increasingly been used in mental and physical health interventions.
There appears to be some consensus about the benefits of standard mindfulness courses, such as Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy on stress, anxiety and depression, and other health conditions.
In terms of physical activity, however, evidence for the use of mindfulness training to promote and improve physical activity is scarce and shows conflicting results.
Evidence suggests that mindfulness training may enhance psychological factors related to exercise, such as intrinsic motivation to engage in physical activity, tolerance of physical activity-related discomfort, and physical activity self-regulation, which could potentially enhance physical activity maintenance in the long run.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Liverpool, United Kingdom, L3 5UG
- Liverpool John Moores University Redmonds Building
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female
- 19-64 years old
- Would like to do more physical activity, but find it boring, uncomfortable, or not enjoyable
- Available and willing to attend all sessions and complete all research measures
Exclusion Criteria:
- Physical disability, cardiovascular condition, or any other illnesses or injuries that would prevent from doing physical activity
- Currently engaging in regular physical activity
- Currently taking medication and/or undergoing therapy for a mental health condition
- Have previously completed a mindfulness course
- Currently engaged in a regular meditation practice
- Away or unavailable on Mondays between 17:30 to 19:30pm for 6 weeks starting 1st October and for other assessment dates up to 17th December 2018
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mindfulness for Physical Activity
A 6-week mindfulness programme (2 hours per week) aimed at increasing physical activity in underactive participants.
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The Mindfulness for Physical Activity (MfPA) programme aims to change participants' relationship with physical activity by targeting psychological factors related to physical activity uptake and maintenance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention feasibility and acceptability
Time Frame: Up to 14 weeks
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Assessed using qualitative data gained through a focus group.
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Up to 14 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical activity acceptance
Time Frame: Up to 14 weeks
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Measured using the Physical Activity Acceptance Questionnaire (PAAQ).
The PAAQ is a 10-item measure, rated on a seven-point Likert scale, ranging from 1 (never true) to 7 (always true), with higher scores indicating higher tolerance for physical activity-related discomfort.
Subscales include cognitive acceptance (e.g., "If I have the thought 'exercising today won't be enjoyable', it derails me from my exercise plan") and behavioural commitment (e.g., "Even if I have the desire to stop while I am exercising, I can still follow my exercise plan").
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Up to 14 weeks
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Change in self-reported physical activity
Time Frame: Up to 14 weeks
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Assessed using the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a 7-item measure, giving a result in multiples of resting metabolic rate (MET), with higher MET minute values indicating more physical activity.
It assesses moderate-intensity physical activity, vigorous-intensity physical activity, walking, and sitting.
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Up to 14 weeks
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Change in objectively measured physical activity
Time Frame: Up to 14 weeks
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Assessed using accelerometers.
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Up to 14 weeks
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Change in physical activity motivation
Time Frame: Up to 14 weeks
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Measured using the Behavioural Regulation in Exercise Questionnaire (BREQ-3).
The BREQ-3 is a 24-item measure, rated on a five-point Likert scale, ranging from 0 (not true for me) to 4 (very true for me), with higher scores indicating higher levels of motivation.
Subscales include amotivation (e.g., "I don't see why I should have to exercise"), external motivation (e.g., "I exercise because other people say I should"), introjected motivation (e.g., "I feel guilty when I don't exercise"), identified motivation (e.g., "It's important to me to exercise regularly"), integrated motivation (e.g., "I exercise because it is consistent with my life goals"), and intrinsic motivation (e.g., "I exercise because it's fun").
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Up to 14 weeks
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Change in self-regulation
Time Frame: Up to 14 weeks
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Measured using the Brief Self-Control Scale (BSCS).
The BSCS is a 13-item measure, rated on a five-point Likert scale, ranging from 1 (not at all like me) to 5 (very much like me), with higher scores indicating higher levels of self-control.
Subscales include inhibition (e.g., "I am good at resisting temptation") and initiation (e.g., "I am able to work effectively toward long-term goals").
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Up to 14 weeks
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Change in dispositional mindfulness
Time Frame: Up to 14 weeks
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Measured using the Five Facet Mindfulness Questionnaire (FFMQ).
The FFMQ is a 15-item measure, rated on a five-point Likert Scale, ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of dispositional mindfulness.
Subscales include acting with awareness (e.g., "When I do things, my mind wanders off and I'm easily distracted"), non-judging (e.g., "I criticize myself for having irrational or inappropriate emotions"), and non-reactivity (e.g., "I perceive my feelings and emotions without having to react to them").
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Up to 14 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2018
Primary Completion (Actual)
November 5, 2018
Study Completion (Actual)
December 17, 2018
Study Registration Dates
First Submitted
September 17, 2018
First Submitted That Met QC Criteria
September 17, 2018
First Posted (Actual)
September 19, 2018
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 26, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MfPA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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