Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

NCT ID: NCT05590507

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-28

Study Completion Date

2023-11-21

Brief Summary

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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

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Conditions

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Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness Audio Recordings

Intervention Type 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 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Emma Fortune Ngufor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emma Fortune-Ngufor, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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22-007713

Identifier Type: -

Identifier Source: org_study_id

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