Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Study Overview
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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.

Official Title
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A Remote Mindfulness-Based Physical Activity Intervention for Postmenopausal Women

Conditions
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Postmenopausal

Intervention / Treatment
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* Behavioral: Mindfulness Audio Recordings


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A/Intervention<br>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<br>* 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<br>|
| No Intervention: Group B/Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily physical activity | 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 |