Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices

Study Overview
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Brief Summary
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To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.

Detailed Description
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Primary objective: To evaluate the feasibility of a CGM-based physical activity intervention that includes the use of CGM and Fitbit®. Secondary objectives: To examine changes in physical activity motivation and other related psychosocial variables (e.g., intention, perceived benefits, outcome expectancy) before and after the intervention. Exploratory objective: Examine cancer-related biomarkers and their associations with daily glucose pattern.

Official Title
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Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices

Conditions
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Cancer, Diabetes

Intervention / Treatment
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* Other: Fitbit
* Other: Continuous Glucose Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women at least 18 years old Body mass index (BMI) 25 kg/m2 Engage in less than 150 minutes of moderate-intensity PA per week in the past month Capable of participating in moderate-vigorous unsupervised exercise (as determined by the Physical Activity Readiness Questionnaire (PARQ) or a medical release from their physician) Self-reported ability to walk one block without pain or discomfort Have a smart phone with daily internet access that is compatible with the LibreLink app Ability to speak, read, and write in English For the cancer survivor cohort (participant accession number #21 and beyond), individuals must have been diagnosed with stage I-III breast or colorectal cancer and completed adjuvant therapy (i.e., chemo and/or radiation therapy). Exclusion Criteria: Self-reported current diagnosis or history of type 1 diabetes or type 2 diabetes Self-reported use of oral antidiabetic agents (OADs) Previous or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness including gestational is allowed at the discretion for the investigator) Current use of a continuous glucose monitor Fasting glucose > 125 mg/dL Pregnancy Self-reported health issues that limit physical activity On dialysis Work overnight shifts Unwilling to use CGM Current participation in other wellness or weight loss-related program or intervention Currently on a low-carb diet Unable to receive REDCap survey through their mobile phones

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart Rate Tracker (Fitbit)<br>continuous heart rate activity | Other: Fitbit<br>* wearable activity tracker<br>Other: Continuous Glucose Monitor<br>* wearable activity tracker<br>|
| Experimental: Continuous Glucose Monitor (CGM)<br>monitoring daily exercise-related activities | Other: Fitbit<br>* wearable activity tracker<br>Other: Continuous Glucose Monitor<br>* wearable activity tracker<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the feasibility of the ( PA) Physical Activity intervention. | The use of CGM through the following criteria: CGM-specific refusal rate <20% at the participant recruitment phase and protocol adherence rates >80% at the end of the monitoring period. | through study completion, an average of 1 year |