NCT03856385

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 12, 2019

Last Update Submit

February 26, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Rapid Assessment of Physical Activity Scale

    self-report scale of physical activity, with total score ranging from 1-10; higher scores indicate increased activity

    one week

  • Daily Step Counts

    Fitbit-HR device data

    one day

  • Screen Time

    self-report measure, 4 items assessing television and non-television time in number of hours

    one week

Secondary Outcomes (5)

  • Perceived Stress Scale

    one month

  • Mental Health Inventory

    one month

  • Brief Edinburgh Depression Scale

    7 days

  • Freiburg Mindfulness Inventory

    7 days

  • Pittsburgh Sleep Quality Index

    one month

Study Arms (2)

Mindful Walking

EXPERIMENTAL

Four weekly 60 minute sessions of mindful walking.

Behavioral: Mindful Walking

Control

NO INTERVENTION

Weekly email messages encouraging physical activity.

Interventions

Mindful WalkingBEHAVIORAL

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.

Mindful Walking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over age 18
  • Able to read and understand English

You may not qualify if:

  • Student athletes
  • Medical condition that limits slow-paced walking for 20 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clemson University

Clemson, South Carolina, 29634, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lu Shi, Ph.D.

    Clemson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 27, 2019

Study Start

May 26, 2017

Primary Completion

August 15, 2017

Study Completion

August 15, 2017

Last Updated

February 27, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared outside the research team

Locations