NCT04086420

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2018

Shorter than P25 for early_phase_1

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 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

September 9, 2019

Last Update Submit

September 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Minutes

    1-Week Follow-Up

Study Arms (2)

Mindfulness

EXPERIMENTAL

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

Behavioral: Mindfulness

Heart-Rate

ACTIVE COMPARATOR

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

Behavioral: Heart-Rate

Interventions

MindfulnessBEHAVIORAL

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

Mindfulness
Heart-RateBEHAVIORAL

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

Heart-Rate

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75205, United States

Location

Related Publications (1)

  • Sala M, Geary B, Baldwin AS. A Mindfulness-Based Physical Activity Intervention: A Randomized Pilot Study. Psychosom Med. 2021 Jul-Aug 01;83(6):615-623. doi: 10.1097/PSY.0000000000000885.

MeSH Terms

Conditions

Motor Activity

Interventions

MindfulnessHeart Rate

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesVital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

May 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations