Clinical trial NCT05124405: Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
Official title: Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cancer
Diabetes
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: To evaluate the feasibility of the ( PA) Physical Activity intervention.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Basen-Engquist, MD
role: PRINCIPAL_INVESTIGATOR
References: