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
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivorship||Behavioral: Glucose-based biofeedback Behavioral: Standard feedback Device: Glucose monitoring||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
|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.
- 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.
- 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.
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
|Contact: Yue Liao, MPH, PhDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Yue Liao, PhD, MPH|
|Principal Investigator:||Yue Liao, MPH, PhD||University of Texas at Arlington|