Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05590507

Collaborator

(none)

Enrollment

Location

Arms

11.1

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal	Behavioral: Mindfulness Audio Recordings	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Actual Study Start Date :

Dec 28, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Emma Fortune Ngufor, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05590507

Other Study ID Numbers:

22-007713

First Posted:

Oct 21, 2022

Last Update Posted:

Jan 10, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Study Results

No Results Posted as of Jan 10, 2023