Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

NCT05590507 | Completed

• 1 other identifier: 22-007713
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Acceptability of a mindfulness-based physical activity intervention

  Number of subjects to rate the remotely-accessible and physical activity-targeted mindfulness audio file as acceptable

  4 weeks

Secondary Outcomes (1)

• Daily physical activity

  4 weeks

Study Arms (2)

Group A/Intervention

EXPERIMENTAL

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

Group B/Control

NO INTERVENTION

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.

Interventions

Mindfulness Audio Recordings BEHAVIORAL

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

Group A/Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Emma Fortune-Ngufor, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 21, 2022
• Study Start: December 28, 2022
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)