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

NCT ID: NCT05124405

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-24

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Primary objective:

To evaluate the feasibility of a CGM-based physical activity intervention that includes the use of CGM and FitbitĀ®.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heart Rate Tracker (Fitbit)

continuous heart rate activity

Group Type EXPERIMENTAL

Fitbit

Intervention Type OTHER

wearable activity tracker

Continuous Glucose Monitor

Intervention Type OTHER

wearable activity tracker

Continuous Glucose Monitor (CGM)

monitoring daily exercise-related activities

Group Type EXPERIMENTAL

Fitbit

Intervention Type OTHER

wearable activity tracker

Continuous Glucose Monitor

Intervention Type OTHER

wearable activity tracker

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fitbit

wearable activity tracker

Intervention Type OTHER

Continuous Glucose Monitor

wearable activity tracker

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karen Basen-Engquist, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40719638 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

M D Anderson Cancer Center website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2019-02652

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0299

Identifier Type: -

Identifier Source: org_study_id