Physical InactivityNCT03856385
Impact of Mindful Walking Intervention on Daily Step Count
A study testing Mindful Walking in people with Physical Inactivity, run by Clemson University at 1 site in United States.
Trial summary
Mindful walking is a meditation practice that combines physical activity and mindfulness practice. This study examined whether a mindful walking intervention increased physical activity and improved health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Mindful Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2017to 15 Aug 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over age 18
- Able to read and understand English
Who cannot join
- Student athletes
- Medical condition that limits slow-paced walking for 20 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Mindful Walking Intervention on Daily Step Count: A Pilot Study
Mindful walking is a meditation practice that combines physical activity and mindfulness practice. This study examined whether a mindful walking intervention increased physical activity and improved health outcomes. The investigators conducted a randomized experiment among adults with inadequate physical activity, whereby the intervention group received a four-week, one-hour-per-week mindful walking intervention and the control group received instructions to increase physical activity (N=38). Participants in both groups received a wrist-worn step count device as participation incentive. Physical activity and health outcomes were measured with an online survey and data obtained from the wearable device at baseline (T1), post-intervention (T2), and one month after the intervention (T3).
- Conditions
- Physical Inactivity
- Being tested
- Mindful Walking
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful WalkingBehavioural
Weekly 60 minute mindful walking sessions involving observations of bodily sensations, experiences, and breath. Discussion of mindful walking experiences and encouragement to meet physical activity goals.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Walking | Experimental | Four weekly 60 minute sessions of mindful walking. Receives: Behavioral: Mindful Walking |
| Control | No intervention | Weekly email messages encouraging physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Assessment of Physical Activity Scale
self-report scale of physical activity, with total score ranging from 1-10; higher scores indicate increased activity
Measured: one week
Daily Step Counts
Fitbit-HR device data
Measured: one day
Screen Time
self-report measure, 4 items assessing television and non-television time in number of hours
Measured: one week
Secondary outcomes (5)
Perceived Stress Scale
self-report measure, total score ranges from 4 to 20, higher levels indicating higher levels of stress
Measured: one month
Mental Health Inventory
self-report measure of health-related quality of life, total score ranging from 5 to 30, with higher levels indicating higher quality of life
Measured: one month
Brief Edinburgh Depression Scale
self-report measure, total score ranging from 6 to 24, with higher levels indicating higher levels of depression symptoms
Measured: 7 days
Freiburg Mindfulness Inventory
self-report measure, total score ranging from 14 to 56 with higher scores indicating higher levels of mindfulness skills
Measured: 7 days
Pittsburgh Sleep Quality Index
self-report measure, total score ranging from 7 to 28, with higher scores indicating worse sleep quality
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start26 May 2017
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clemson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Zinzow, Clemson University
- Investigators
- Lu Shi, Ph.D., Principal investigator, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856385
- Sponsor's protocol ID
- IRB2017-099
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside the research team
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
- Impact of Mindful Walking Intervention on Daily Step Count: A Pilot Study
- ClinicalTrials.gov ID
- NCT03856385
- Acronym / sponsor ID
- IRB2017-099
- Conditions
- Physical Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Clemson UniversityUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 27 Feb 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.
Mindful walking is a meditation practice that combines physical activity and mindfulness practice. This study examined whether a mindful walking intervention increased physical activity and improved health outcomes. The investigators conducted a randomized experiment among adults with inadequate physical activity, whereby the intervention group received a four-week, one-hour-per-week mindful walking intervention and the control group received instructions to increase physical activity (N=38). Participants in both groups received a wrist-worn step count device as participation incentive. Physical activity and health outcomes were measured with an online survey and data obtained from the wearable device at baseline (T1), post-intervention (T2), and one month after the intervention (T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Walking | Experimental | Behavioral: Mindful WalkingFour weekly 60 minute sessions of mindful walking. |
| Control | No intervention | –Weekly email messages encouraging physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults over age 18
- Able to read and understand English
Key exclusion criteria (2 listed)
- Student athletes
- Medical condition that limits slow-paced walking for 20 minutes
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 |
|---|---|---|
| Mindful WalkingWeekly 60 minute mindful walking sessions involving observations of bodily sensations, experiences, and breath. Discussion of mindful walking experiences and encouragement to meet physical activity goals. | Behavioural | Mindful Walking |
Primary outcome
Rapid Assessment of Physical Activity Scale
Time frame: one week
self-report scale of physical activity, with total score ranging from 1-10; higher scores indicate increased activity
Daily Step Counts
Time frame: one day
Fitbit-HR device data
Screen Time
Time frame: one week
self-report measure, 4 items assessing television and non-television time in number of hours
5 secondary outcomes
Perceived Stress Scale
Time frame: one month
Mental Health Inventory
Time frame: one month
Brief Edinburgh Depression Scale
Time frame: 7 days
Freiburg Mindfulness Inventory
Time frame: 7 days
Pittsburgh Sleep Quality Index
Time frame: one month
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. IPD will not be shared outside the research team
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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.
Lu Shi, Ph.D. principal investigator
Clemson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Walking in people with Physical Inactivity, run by Clemson 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 2 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 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 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.
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?
Rapid Assessment of Physical Activity Scale (time frame: one week). The study lists 3 primary outcomes in all. 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.