Know and Own Your Movement-related Metrics Via Wearable Devices

NCT ID: NCT05490641

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-29

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Cancer Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Biofeedback Group

Group Type EXPERIMENTAL

Glucose-based biofeedback

Intervention Type 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 Care Group

Group Type ACTIVE_COMPARATOR

Standard feedback

Intervention Type BEHAVIORAL

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

Interventions

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Glucose-based biofeedback

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.

Intervention Type BEHAVIORAL

Standard feedback

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Institute for Cancer Research

OTHER

Sponsor Role collaborator

The University of Texas at Arlington

OTHER

Sponsor Role lead

Responsible Party

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Yue Liao

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yue Liao, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Arlington

Locations

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The University of Texas at Arlington

Arlington, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yue Liao, MPH, PhD

Role: CONTACT

18172728529

Facility Contacts

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Physical Activity and Wearable Sensors Lab

Role: primary

8172728524

References

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Liao Y, Schembre SM, Brannon GE, Pan Z, Wang J, Ali S, Beg MS, Basen-Engquist KM. Using wearable biological sensors to provide personalized feedback to motivate behavioral changes: Study protocol for a randomized controlled physical activity intervention in cancer survivors (Project KNOWN). PLoS One. 2022 Sep 13;17(9):e0274492. doi: 10.1371/journal.pone.0274492. eCollection 2022.

Reference Type DERIVED
PMID: 36099282 (View on PubMed)

Other Identifiers

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2022-0177

Identifier Type: -

Identifier Source: org_study_id

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