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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

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