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Trial Title:
Know and Own Your Movement-related Metrics Via Wearable Devices
NCT ID:
NCT05490641
Condition:
Cancer
Survivorship
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Glucose-based biofeedback
Description:
Participants will wear a Fitbit activity tracker and receive personalized text messages
over a 12-week period. During the first 4 weeks of the study period, participants will
also wear a continuous glucose monitor to check their glucose levels in real-time and
receive text messages based on their activity and glucose data.
Arm group label:
Biofeedback Group
Intervention type:
Behavioral
Intervention name:
Standard feedback
Description:
Participants will wear a Fitbit activity tracker and receive non-personalized text
messages over a 12-week period.
Arm group label:
Standard Care Group
Summary:
This study aims to promote daily physical activity in cancer survivors who are at high
risk for type 2 diabetes (T2D) by using a personalized biological-based feedback
strategy. T2D is one of the most common co-occurring conditions in cancer survivors and
can worsen cancer-related health outcomes, especially in those who are insufficiently
active. The investigators hypothesize that seeing the immediate impacts of exercise on
their biological status will motivate cancer survivors to exercise. The investigators
will use real-time data from continuous glucose monitor to demonstrate the acute impact
of physical activity and measure daily activity levels using wearable trackers. As
wearable sensor technology is constantly advancing, this study is the first step to
exploring how researchers can use wearable sensors to help people make a direct
connection between their daily behaviors and health outcomes.
Detailed description:
Physical activity plays an important role in energy balance and obesity, which is an
independent risk factor for cancer recurrence and mortality. It has been estimated that
cancer survivors who increased their physical activity from pre- to post-diagnosis by any
level had a 39% risk reduction in total mortality. This study will use an innovative
approach to motivate cancer survivors to adopt and maintain an active lifestyle and will
explore a novel mediator (daily glucose pattern) of the association between physical
activity and cancer-related biomarkers. Study participants will be randomly assigned into
(1) a group that receives personalized biological feedback related to physical activity
behaviors; and (2) a control group that receives standard educational material. The
feasibility and preliminary efficacy of this wearable sensor-based, biofeedback-enhanced
12-week physical activity intervention will be evaluated. This study will provide data
regarding the preliminary efficacy of using biological feedback to increase physical
activity and identifying daily glucose patterns that might link to cancer-related
biomarkers.
The overall goals for this study are: (1) to test the preliminary effect of a remotely
delivered physical activity intervention that incorporates personalized biological-based
feedback on daily physical activity levels, and (2) to explore the association between
daily glucose patterns and cancer-related insulin pathway and inflammatory biomarkers in
cancer survivors who are at high risk for type 2 diabetes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- be 18 years or older
- have had a diagnosis of cancer
- have completed curative-intended treatment for at least 3 months (except hormone
therapy or long-term maintenance chemotherapy)
- be at high-risk for type 2 diabetes based on the American Diabetes Association Type
2 Diabetes Risk Test
- currently insufficiently active
- capable of participating in moderate-vigorous intensity unsupervised exercise
- have no current diagnosis or history of type 1 or 2 diabetes
- able to speak, read, and write in English
- have a smartphone with daily internet access
Exclusion Criteria:
- currently taking oral antidiabetic agents (OADs)
- current treatment with any insulin regimen other than basal insulin, e.g. prandial
or pre-mixed insulin
- currently pregnant
- on dialysis
- have self-reported health issues that limit physical activity
- work overnight shifts
- unwilling to use the study devices
- current participation in other exercise or weight loss-related program or
intervention
- currently on a low-carb diet
- current use of other implanted medical devices such as pacemakers
- do not have a smartphone that is compatible with the Fitbit and the LibreLink apps
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Texas at Arlington
Address:
City:
Arlington
Zip:
76010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Physical Activity and Wearable Sensors Lab
Phone:
817-272-8524
Email:
pawslab@uta.edu
Investigator:
Last name:
Yue Liao, PhD, MPH
Email:
Principal Investigator
Start date:
March 29, 2023
Completion date:
December 1, 2024
Lead sponsor:
Agency:
The University of Texas at Arlington
Agency class:
Other
Collaborator:
Agency:
American Institute for Cancer Research
Agency class:
Other
Source:
The University of Texas at Arlington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490641