Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
Study Details
Study Description
Brief Summary
To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Heart Rate Tracker (Fitbit) continuous heart rate activity |
Other: Fitbit
wearable activity tracker
Other: Continuous Glucose Monitor
wearable activity tracker
|
| Experimental: Continuous Glucose Monitor (CGM) monitoring daily exercise-related activities |
Other: Fitbit
wearable activity tracker
Other: Continuous Glucose Monitor
wearable activity tracker
|
Outcome Measures
Primary Outcome Measures
- To evaluate the feasibility of the ( PA) Physical Activity intervention. [through study completion, an average of 1 year]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Karen Basen-Engquist, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2018-0299