- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03856385
Impact of Mindful Walking Intervention on Daily Step Count
February 26, 2019 updated by: Heidi Zinzow, Clemson University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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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South Carolina
-
Clemson, South Carolina, United States, 29634
- Clemson University
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults over age 18
- Able to read and understand English
Exclusion Criteria:
- Student athletes
- Medical condition that limits slow-paced walking for 20 minutes
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindful Walking
Four weekly 60 minute sessions of mindful walking.
|
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.
|
No Intervention: Control
Weekly email messages encouraging physical activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
one week
|
Daily Step Counts
Time Frame: one day
|
Fitbit-HR device data
|
one day
|
Screen Time
Time Frame: one week
|
self-report measure, 4 items assessing television and non-television time in number of hours
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale
Time Frame: one month
|
self-report measure, total score ranges from 4 to 20, higher levels indicating higher levels of stress
|
one month
|
Mental Health Inventory
Time Frame: one month
|
self-report measure of health-related quality of life, total score ranging from 5 to 30, with higher levels indicating higher quality of life
|
one month
|
Brief Edinburgh Depression Scale
Time Frame: 7 days
|
self-report measure, total score ranging from 6 to 24, with higher levels indicating higher levels of depression symptoms
|
7 days
|
Freiburg Mindfulness Inventory
Time Frame: 7 days
|
self-report measure, total score ranging from 14 to 56 with higher scores indicating higher levels of mindfulness skills
|
7 days
|
Pittsburgh Sleep Quality Index
Time Frame: one month
|
self-report measure, total score ranging from 7 to 28, with higher scores indicating worse sleep quality
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lu Shi, Ph.D., Clemson University
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)
May 26, 2017
Primary Completion (Actual)
August 15, 2017
Study Completion (Actual)
August 15, 2017
Study Registration Dates
First Submitted
February 12, 2019
First Submitted That Met QC Criteria
February 26, 2019
First Posted (Actual)
February 27, 2019
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
Other Study ID Numbers
- IRB2017-099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared outside the research team
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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