Cancer, Diabetes
Conditions
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.
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.
Interventions
OTHERFitbit
wearable activity tracker
OTHERContinuous Glucose Monitor
wearable activity tracker
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren Basen-Engquist, MD
M.D. Anderson Cancer Center
Outcome results
None listed