Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Not Applicable

Completed

• Conditions: Postmenopausal
• Interventions: Behavioral: Mindfulness Audio Recordings

• Registration Number: NCT05590507
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-21
• Study Start: 2022-12-28
• Primary Completion: 2023-11-21
• Study Completion: 2023-11-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A/Intervention	Mindfulness Audio Recordings	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of a mindfulness-based physical activity intervention	4 weeks	Number of subjects to rate the remotely-accessible and physical activity-targeted mindfulness audio file as acceptable

Secondary Outcome Measures

Name	Time	Method
Daily physical activity	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

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States