Know and Own Your Movement-related Metrics Via Wearable Devices (Project KNOWN)

May 8, 2024 updated by: The University of Texas at Arlington

Personalized Feedback of Wearable Biological Sensor Data to Promote Active Living in Cancer Survivors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Arlington, Texas, United States, 76010
        • Recruiting
        • The University of Texas at Arlington
        • Contact:
          • Physical Activity and Wearable Sensors Lab
          • Phone Number: 817-272-8524
          • Email: pawslab@uta.edu
        • Principal Investigator:
          • Yue Liao, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback Group
Behavioral: Glucose-based biofeedback
Participants will wear a Fitbit activity tracker and receive personalized text messages over a 12-week period.
Device: Glucose monitoring
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.
Active Comparator: Standard Care Group
Behavioral: Standard feedback
Participants will wear a Fitbit activity tracker and receive non-personalized text messages over a 12-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of delivering personalized glucose-based feedback
Time Frame: Through study completion, an average of 3 months.
The intervention will be considered feasible if ≥ 80% of participants in the intervention group are adherent to the self-monitoring protocol and ≥ 80% of participants complete the post-intervention assessment.
Through study completion, an average of 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in daily physical activity level
Time Frame: Through study completion, an average of 3 months.
A blinded accelerometry device will be used to measure physical activity before and after the intervention.
Through study completion, an average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas at Arlington

Collaborators

American Institute for Cancer Research

Investigators

  • Principal Investigator: Yue Liao, MPH, PhD, University of Texas at Arlington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 1, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-0177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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