Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

March 20, 2024 updated by: Emma Fortune Ngufor, Mayo Clinic

A Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

The purpose of this study is to figure out if postmenopausal women find a mindfulness audio recording acceptable for use along with physical activity, and to find out if this tool is helpful in increasing daily physical activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

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

Description

Inclusion Criteria:

  • Patients self-report as being > 1 year postmenopausal.
  • Patients are able to walk without a walking aid.
  • Patients own and know how to operate a smart phone or tablet.
  • Patients are willing and able to complete the activity monitoring.
  • Patients are self-reportedly underactive.

Exclusion Criteria:

  • Patients are < 1 year postmenopausal.
  • Patients require a walking aid for daily mobility.
  • Patients do not own a smartphone or table, or are unwilling to use such a device for the purposes of the study.
  • Patients' primary form of exercise is swimming (the activity monitors are not waterproof).
  • Patients are unable or unwilling to complete activity monitoring.
  • Patients are unable to provide informed consent independently.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A/Intervention
Subjects will use mindfulness audio recordings along with their physical activity, and will receive a weekly health coaching phone call along with supplemental educational materials.
Behavioral: Mindfulness Audio Recordings
A 5-minute audio file aimed to increase likelihood of experiencing positive affect associated with physical activity. Participants will listen to a mindfulness audio file at the beginning of each physical activity session they choose to engage in during weeks 2-4
No Intervention: Group B/Control
Subjects will receive education materials on healthy habits for increasing physical activity based on the National Institutes of Health, and bi-weekly check-in phone call.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of a mindfulness-based physical activity intervention
Time Frame: 4 weeks
Number of subjects to rate the remotely-accessible and physical activity-targeted mindfulness audio file as acceptable
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily physical activity
Time Frame: 4 weeks
Number of subjects to have an increase in objectively measured daily physical activity variables (such as step counts) recorded by ActiGraph activity monitor
4 weeks

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Emma Fortune-Ngufor, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

December 28, 2022

Primary Completion (Actual)

November 21, 2023

Study Completion (Actual)

November 21, 2023

Study Registration Dates

First Submitted

October 19, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 22-007713

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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