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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05124405
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
44.3
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Fitbit
  • Other: Continuous Glucose Monitor
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Monitoring Your Exercise-related Metrics Over Time Via Wearable Electronic Devices
Actual Study Start Date :
May 24, 2018
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1M D Anderson Cancer CenterHoustonTexasUnited States77030

Sponsors and Collaborators

  • M.D. Anderson Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT05124405
Other Study ID Numbers:
  • 2018-0299
First Posted:
Nov 18, 2021
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 26, 2021