Physical ActivityNCT03677687
Mindfulness for Physical Activity Research Project
A study testing Mindfulness for Physical Activity in people with Physical Activity, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
This study aims to evaluate the feasibility and preliminary effectiveness of a Mindfulness for Physical Activity programme on physical activity outcomes in underactive participants. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Mindfulness for Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Sep 2018to 17 Dec 2018
- Phase
- Interventional
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University Redmonds Building
Liverpool, L3 5UG
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Mindfulness for Physical Activity
- Keywords
- Mindfulness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness for Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness for Physical Activity | Experimental | A 6-week mindfulness programme (2 hours per week) aimed at increasing physical activity in underactive participants. Receives: Behavioral: Mindfulness for Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility and acceptability
Assessed using qualitative data gained through a focus group.
Measured: Up to 14 weeks
Secondary outcomes (6)
Change in physical activity acceptance
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").
Measured: Up to 14 weeks
Change in self-reported physical activity
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.
Measured: Up to 14 weeks
Change in objectively measured physical activity
Assessed using accelerometers.
Measured: Up to 14 weeks
Change in physical activity motivation
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").
Measured: Up to 14 weeks
Change in self-regulation
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").
Measured: Up to 14 weeks
Change in dispositional mindfulness
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").
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start17 Sep 2018
- Primary completion5 Nov 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kat Schneider, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677687
- Sponsor's protocol ID
- MfPA
- Status last verified
- Feb 2019
- First submitted
- 17 Sep 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Mindfulness-based Programme to Facilitate Physical Activity Uptake in Underactive Participants: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03677687
- Acronym / sponsor ID
- MfPA
- Conditions
- Physical Activity
- Keywords
- Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 19 Sep 2018 (actual)
- 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.
This study aims to evaluate the feasibility and preliminary effectiveness of a Mindfulness for Physical Activity programme on physical activity outcomes in underactive participants.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness for Physical Activity | Experimental | Behavioral: Mindfulness for Physical ActivityA 6-week mindfulness programme (2 hours per week) aimed at increasing physical activity in underactive participants. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Mindfulness for Physical ActivityThe 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. | Behavioural | Mindfulness for Physical Activity |
Primary outcome
Intervention feasibility and acceptability
Time frame: Up to 14 weeks
Assessed using qualitative data gained through a focus group.
6 secondary outcomes
Change in physical activity acceptance
Time frame: Up to 14 weeks
Change in self-reported physical activity
Time frame: Up to 14 weeks
Change in objectively measured physical activity
Time frame: Up to 14 weeks
Change in physical activity motivation
Time frame: Up to 14 weeks
Change in self-regulation
Time frame: Up to 14 weeks
Change in dispositional mindfulness
Time frame: Up to 14 weeks
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 27 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Physical Activity
Recruiting
Effectivity of P1821, a Novel Tongue Strengthening and Endurance Enhancing Speech Flow Exercise
Ankyloglossia, Impairment of Speech
RecruitingPhase 1
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
Solid Tumor
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
RecruitingPhase 2/3
The Effect of Additive On-Demand Sildenafil vs. Dextrose Candy on Maximum Exercise Capacity in Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
RecruitingEarly Phase 1
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Oligometastatic Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness for Physical Activity in people with Physical Activity, run by Liverpool John Moores University at 1 site in United Kingdom.
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 4 inclusion and 6 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 27 Feb 2019. 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 United Kingdom. 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.
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?
Intervention feasibility and acceptability (time frame: Up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2019.