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

May 18, 2026 updated by: M.D. Anderson Cancer Center
To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Karen Basen-Engquist, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2018

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0299
  • NCI-2019-02652 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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