Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
2 other identifiers
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started May 2018
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2018
CompletedFirst Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
November 10, 2025
November 1, 2025
8.7 years
May 20, 2019
November 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Heart Rate Tracker (Fitbit)
EXPERIMENTALcontinuous heart rate activity
Continuous Glucose Monitor (CGM)
EXPERIMENTALmonitoring daily exercise-related activities
Interventions
wearable activity tracker
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Liao Y, Brannon GE, Rethorst CD, Baum M, Bevers TB, Schembre SM, Basen-Engquist KM. Using Continuous Glucose Monitoring as a Biological Feedback Strategy to Motivate Physical Activity in Cancer Survivors: A Mixed-Methods Pilot Study. Cancer Control. 2025 Jan-Dec;32:10732748251359406. doi: 10.1177/10732748251359406. Epub 2025 Jul 28.
PMID: 40719638DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Basen-Engquist, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2019
First Posted
November 18, 2021
Study Start
May 24, 2018
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
November 10, 2025
Record last verified: 2025-11