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OpenTrials
Active, Not Recruiting

NCT Number: NCT05124405

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

To test the use of a continuous activity and heart rate tracker (Fitbit) and continuous glucose monitor (CGM) in monitoring daily exercise-related activities.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FitBit

Other

wearable activity tracker

Continuous Glucose Monitor

Other

wearable activity tracker

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2021
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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