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

Not Applicable

Suspended

• Conditions: Cancer; Diabetes
• Interventions: Other: Fitbit; Other: Continuous Glucose Monitor

• Registration Number: NCT05124405
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-24
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 35

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous Glucose Monitor (CGM)	Continuous Glucose Monitor	monitoring daily exercise-related activities
Heart Rate Tracker (Fitbit)	Continuous Glucose Monitor	continuous heart rate activity
Continuous Glucose Monitor (CGM)	Fitbit	monitoring daily exercise-related activities
Heart Rate Tracker (Fitbit)	Fitbit	continuous heart rate activity

Primary Outcome Measures

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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States