Mindfulness-Based Physical Activity Intervention

Sponsor

Southern Methodist University (Other)

Overall Status

Completed

CT.gov ID

NCT04086420

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

24.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Mindfulness Physical Activity	Behavioral: Mindfulness Behavioral: Heart-Rate	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Jul 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Delivered through an audio-recording consisting of a single meditation exercise that lasted for 30 minutes	Behavioral: Mindfulness Received instructions to exercise at moderate intensity while listening to an audio-recorded mindfulness-based physical activity intervention
Active Comparator: Heart-Rate Given a heart rate monitor and instructed to use it to determine the intensity of their exercise	Behavioral: Heart-Rate Given a heart rate monitor, told to exercise within the moderate intensity range (64-76% of estimated maximum heart rate)

Arm

Intervention/Treatment

Experimental: Mindfulness

Delivered through an audio-recording consisting of a single meditation exercise that lasted for 30 minutes

Behavioral: Mindfulness

Received instructions to exercise at moderate intensity while listening to an audio-recorded mindfulness-based physical activity intervention

Active Comparator: Heart-Rate

Given a heart rate monitor and instructed to use it to determine the intensity of their exercise

Behavioral: Heart-Rate

Given a heart rate monitor, told to exercise within the moderate intensity range (64-76% of estimated maximum heart rate)

Outcome Measures

Primary Outcome Measures

Physical Activity Minutes [1-Week Follow-Up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Methodist University	Dallas	Texas	United States	75205

Sponsors and Collaborators

Southern Methodist University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Southern Methodist University

ClinicalTrials.gov Identifier:

NCT04086420

Other Study ID Numbers:

H18-046 SALM

First Posted:

Sep 11, 2019

Last Update Posted:

Sep 11, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 11, 2019