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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05124405
• Other study ID #: 2018-0299
• Secondary ID: NCI-2019-02652
• Status: Suspended
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 35
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Diabetes

Intervention

Other:
• Fitbit
wearable activity tracker
• Continuous Glucose Monitor
wearable activity tracker

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center website