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NCT Number: NCT05490641

Know and Own Your Movement-related Metrics Via Wearable Devices

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.

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Key information

Conditions

Cancer Neoplasms Survivorship

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Arlington

Arlington, Texas, 76010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose-based biofeedback

Behavioral

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.

Standard feedback

Behavioral

Participants will wear a Fitbit activity tracker and receive non-personalized text messages over a 12-week period.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Collaborators

  • American Institute for Cancer Research

Registry information

Official study title

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

Acronym: Project KNOWN

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2022
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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