MindfulnessEarly Phase 1NCT04086420
Mindfulness-Based Physical Activity Intervention
A Early Phase 1 study testing Mindfulness and Heart-Rate in people with Mindfulness and Physical Activity, run by Southern Methodist University at 1 site in United States.
Trial summary
The aims of this parallel two-arm pilot randomized controlled trial is to assess the feasibility and acceptability of an audio-recorded mindfulness-based intervention and to assess whether the intervention results in a clinically meaningful difference in physical activity compared to the control condition Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Physical Activity
- What is being tested?
- Mindfulness and Heart-Rate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Jul 2018
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reported less than 60-minutes of weekly moderate-to-vigorous physical activity (MVPA, moderate physical activity minutes + vigorous physical activity minutes*2)
- Safe to exercise at moderate intensity without a doctor's approval according to American College of Sports Medicine Criteria
- Had a smart phone to access the audio-recorded mindfulness-based physical activity intervention
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study
The aims of this parallel two-arm pilot randomized controlled trial is to assess the feasibility and acceptability of an audio-recorded mindfulness-based intervention and to assess whether the intervention results in a clinically meaningful difference in physical activity compared to the control condition
- Conditions
- Mindfulness, Physical Activity
- Being tested
- Mindfulness, Heart-Rate
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Received instructions to exercise at moderate intensity while listening to an audio-recorded mindfulness-based physical activity intervention
Heart-RateBehavioural
Given a heart rate monitor, told to exercise within the moderate intensity range (64-76% of estimated maximum heart rate)
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Delivered through an audio-recording consisting of a single meditation exercise that lasted for 30 minutes Receives: Behavioral: Mindfulness |
| Heart-Rate | Active comparator | Given a heart rate monitor and instructed to use it to determine the intensity of their exercise Receives: Behavioral: Heart-Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Minutes
Measured: 1-Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 May 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
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 MindfulnessStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086420
- Sponsor's protocol ID
- H18-046 SALM
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sala M, Geary B, Baldwin AS. A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study. Psychosom Med. 2021 Jul-Aug 01;83(6):615-623. doi: 10.1097/PSY.0000000000000885.
PubMed 33165218
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04086420
- Acronym / sponsor ID
- H18-046 SALM
- Conditions
- Mindfulness, Physical Activity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 11 Sep 2019 (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.
The aims of this parallel two-arm pilot randomized controlled trial is to assess the feasibility and acceptability of an audio-recorded mindfulness-based intervention and to assess whether the intervention results in a clinically meaningful difference in physical activity compared to the control condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessDelivered through an audio-recording consisting of a single meditation exercise that lasted for 30 minutes |
| Heart-Rate | Active comparator | Behavioral: Heart-RateGiven a heart rate monitor and instructed to use it to determine the intensity of their exercise |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Reported less than 60-minutes of weekly moderate-to-vigorous physical activity (MVPA, moderate physical activity minutes + vigorous physical activity minutes*2)
- Safe to exercise at moderate intensity without a doctor's approval according to American College of Sports Medicine Criteria
- Had a smart phone to access the audio-recorded mindfulness-based physical activity intervention
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MindfulnessReceived instructions to exercise at moderate intensity while listening to an audio-recorded mindfulness-based physical activity intervention | Behavioural | Mindfulness |
| Heart-RateGiven a heart rate monitor, told to exercise within the moderate intensity range (64-76% of estimated maximum heart rate) | Behavioural | Heart-Rate |
Primary outcome
Physical Activity Minutes
Time frame: 1-Week Follow-Up
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 11 Sep 2019.
- Derived from this study: PubMed 33165218Sala M, Geary B, Baldwin AS. A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study. Psychosom Med. 2021 Jul-Aug 01;83(6):615-623. doi: 10.1097/PSY.0000000000000885.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing Mindfulness and Heart-Rate in people with Mindfulness and Physical Activity, run by Southern Methodist University at 1 site in United States.
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 0 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 11 Sep 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 States. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Physical Activity Minutes (time frame: 1-Week Follow-Up). 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 NCT04086420, 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 11 Sep 2019.