Skip to main content
Clinical Trials/NCT05124405
NCT05124405
Active, not recruiting
Not Applicable

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

M.D. Anderson Cancer Center1 site in 1 country35 target enrollmentMay 24, 2018
ConditionsCancerDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
M.D. Anderson Cancer Center
Enrollment
35
Locations
1
Primary Endpoint
To evaluate the feasibility of the ( PA) Physical Activity intervention.
Status
Active, not recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 24, 2018
End Date
January 31, 2027
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

To evaluate the feasibility of the ( PA) Physical Activity intervention.

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials