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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05490641
Recruitment Status : Recruiting
First Posted : August 5, 2022
Last Update Posted : November 1, 2022
Sponsor:
Collaborator:
American Institute for Cancer Research
Information provided by (Responsible Party):
The University of Texas at Arlington

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Survivorship Behavioral: Glucose-based biofeedback Behavioral: Standard feedback Device: Glucose monitoring Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Personalized Feedback of Wearable Biological Sensor Data to Promote Active Living in Cancer Survivors
Estimated Study Start Date : January 15, 2023
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05490641


Contacts
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Contact: Yue Liao, MPH, PhD 18172728529 yue.liao@uta.edu

Locations
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United States, Texas
The University of Texas at Arlington Recruiting
Arlington, Texas, United States, 76010
Contact: Physical Activity and Wearable Sensors Lab    817-272-8524    pawslab@uta.edu   
Principal Investigator: Yue Liao, PhD, MPH         
Sponsors and Collaborators
The University of Texas at Arlington
American Institute for Cancer Research
Investigators
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Principal Investigator: Yue Liao, MPH, PhD University of Texas at Arlington
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The University of Texas at Arlington
ClinicalTrials.gov Identifier: NCT05490641    
Other Study ID Numbers: 2022-0177
First Posted: August 5, 2022    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes