Mindful Walking Intervention for Physical Inactivity

March 6, 2024 updated by: Heidi Zinzow, Clemson University

Mindfulness Training for Adults With Physical Inactivity

Mindful walking is a meditation practice that combines physical activity and mindfulness practice. The purpose of this study is to examine the effectiveness of mindfulness-based interventions provided for increasing physical activity among adults with low physical activity levels. A randomized controlled trial design will be utilized, with an intervention and waitlist control group (N = 160). Outcomes measured include physical activity, sleep quality, and functional fitness. Participants will receive a total of eight sessions of 60-minute mindful walking training within four weeks. The intervention group will receive the training in Weeks 1-4 and the control group will receive the training during Weeks 5-8. Each training group will consist of up to 20 individuals. Data will be collected at baseline, four weeks, and eight weeks to determine the efficacy of the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • South Carolina
      • Clemson, South Carolina, United States, 29634
        • Clemson University
      • Greenville, South Carolina, United States, 296012
        • Caine Halter Family YMCA
      • Greenville, South Carolina, United States, 29605
        • Prisma Health-Upstate Internal Medicine Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 and above
  • English speaking
  • Literacy 6th grade and above
  • Willingness to share contact information (home address, phone number)
  • No current mindfulness practice
  • Greenville residents or persons who are patients of the partnering organizations in the investigator's study.
  • Self-reported physical activity level below the CDC recommended guidelines (150 minutes (2 hours and 30 minutes) a week of moderate-intensity, or 75 minutes (1 hour and 15 minutes ) a week of vigorous-intensity aerobic activity, or an equivalence combination of moderate- and vigorous intensity aerobic activity

Exclusion Criteria:

  • <18 years old
  • Non-English-speaking
  • Literacy lower than 6th grade
  • Inability to attend intervention sessions
  • Already completed or attending a mindfulness-based intervention
  • Current pregnancy
  • Current/past psychosis
  • Acute episode of a substance use disorder (past two weeks)
  • Acute episode of depression in the past two weeks
  • Moderate to severe traumatic brain injury or brain damage
  • Persistent antisocial behavior
  • Persistent self-injury requiring clinical management
  • Unable to engage for physical or practical reasons (e.g., disabling physical problems, unable to comprehend material)
  • Dementia
  • Suicidality
  • Inability to do light walking for 10 mins at a stretch
  • Severely obese BMI (>50 kg/m2)

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindful Walking
Eight 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. The intervention will take place two times per week for four weeks (Weeks 1-4). During weeks 5-8 the experimental group will continue treatment as usual and will not be receiving the mindful walking intervention.
Behavioral: Mindful Walking
Eight 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
Participants will engage in treatment as usual during the first four weeks and will not be receiving the experimental intervention (mindful walking) during weeks 1-4. After the experimental group completes the mindful walking intervention, the control group will complete the mindful walking intervention (weeks 5-8).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in physical activity
Time Frame: Scale administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Rapid Assessment of Physical Activity Scale: self-report scale of physical activity, with total score ranging from 1-10; higher scores indicate increased activity
Scale administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in muscle strength
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Upper and lower muscle strength will be measured with the 30-second arm curl test (number of biceps curls completed while holding a hand weight of 2.27 kg for women and 3.63 kg for men) and the 30-second chair-stand test (Prakhinkit et al. 2014).
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in sleep quality
Time Frame: Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Pittsburgh Sleep Quality Index: 19 item self-report measure assessing sleep quality over the past month, total score ranging from 0 to 21, with higher scores indicating worse sleep quality
Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in flexibility
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
The back scratch flexibility test (how close the hands can be brought together behind the back) and the chair sit-and-reach test will be used to measure upper and lower limb flexibility, respectively (Prakhinkit et al. 2014).
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in agility
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
The timed up-and-go test will be used as a measure of agility (Prakhinkit et al. 2014)
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in dynamic balance
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
The Star Excursion Balance Test will measure dynamic balance (Gribble, Hertel, and Plisky 2012)
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in cardiorespiratory endurance
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
6 minute walk test, measure includes how many meters the individual walks in 6 minutes around a 50-yard course (Prakhinkit et al. 2014)
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in perceived stress
Time Frame: Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Perceived Stress Scale: 4 item self-report measure assessing perceived stress over the past month, total score ranges from 4 to 20, higher levels indicating higher levels of stress
Assessment administered at pre-intervention/baseline, 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in adherence to medications
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Adherence to Refills and Medications Scale: 12 item self-report scale assesses adherence to other medication treatments; scores range from 12-34, where lower scores indicate better adherence (adherence to medications not given as part of this study) (Kripalani et al. 2009)
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in mindfulness skills
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
The Five Facet Mindfulness Questionnaire: 39 self-report items assessing five dimensions of mindfulness. Items are rated on a 5 point scale ranging from 1 to 5, with total score ranging from 39 to 195. Higher scores indicate greater dispositional tendency to be mindful in daily life (e.g., observing, describing, acting with awareness, nonjudging of inner experience, nonreactivity to inner experiences).
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Change in executive functioning
Time Frame: Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Executive Function Index: A 27-item self-report inventory assessing five facets of executive functioning (Spinella, 2005); Items rated "how well the following statement describes me" 1 (not at all) to 5 (very much), range 27-135 with higher scores indicating higher levels of executive functioning.
Assessment administered at pre-intervention (baseline), 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Mindfulness practice behavior
Time Frame: Assessment administered at 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)
Additional mindfulness practices engaged in outside of the study sessions over the past month, assessed with four self-report items: 'Did you engage in mindfulness meditation in the past month?', 'How many days per week did you engage in mindfulness meditation?', 'How long in minutes did you meditate per session of mindfulness meditation?', 'Describe your practice of mindfulness meditation (what exercises/activities/techniques did you practice?)
Assessment administered at 4 weeks (post-intervention for experimental group), 8 weeks (post-intervention for control group and follow-up for experimental group)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic Information
Time Frame: Assessed at pre-intervention/baseline
Age, race, ethnicity, marital status, language spoken, highest level of education, employment status, annual household income, health insurance, current smoking
Assessed at pre-intervention/baseline
Satisfaction with treatment
Time Frame: Administered at 4 weeks for experimental group and 8 weeks for control group.
Treatment Satisfaction Survey (Zgierska et al. 2008), 5 item self-report measure, qualitative and quantitative items with quantitative scale ranging from 0 to 16, with higher scores indicating greater satisfaction with mindfulness intervention
Administered at 4 weeks for experimental group and 8 weeks for control group.
Adverse childhood experiences
Time Frame: First 18 years of life
Adverse Childhood Experiences Questionnaire: 10 item self-report scale assesses adverse events in the first 18 years of life (Felitti, 1998). Scores range from 0 to 10, with higher scores indicating greater number or adverse events.
First 18 years of life
Traumatic event history
Time Frame: Assessed at pre-intervention/baseline
Life Events Checklist for DSM-5: 17 self-report items that assess a number of different types of traumatic events across the lifespan and personal occurrence versus learning about a traumatic event (Weathers et al., 2013). There is no formal scoring protocol, although endorsing 1 or more items indicates lifetime exposure to a traumatic event.
Assessed at pre-intervention/baseline
Use of psychological services
Time Frame: Assessed at pre-intervention/baseline
The Adult Service Use Schedule: Fifteen open-ended, self-report items assessing use of psychological services, accessibility, and length of service use (Bower et al., 2000).
Assessed at pre-intervention/baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clemson University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prisma Health-Upstate
YMCA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lu Shi, PhD, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00092710

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings