Know and Own Your Movement-related Metrics Via Wearable Devices

NCT05490641 | Completed

• 1 other identifier: 2022-0177
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Survivorship

Outcome Measures

Primary Outcomes (1)

• Feasibility of delivering personalized glucose-based feedback

  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 Outcomes (1)

• Changes in daily physical activity level

  Through study completion, an average of 3 months.

Study Arms (2)

Biofeedback Group

EXPERIMENTAL

Behavioral: Glucose-based biofeedback

Standard Care Group

ACTIVE COMPARATOR

Behavioral: Standard feedback

Interventions

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.

Biofeedback Group

Standard feedback BEHAVIORAL

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

Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Arlington: lead
• American Institute for Cancer Research: collaborator

Study Sites (1)

The University of Texas at Arlington

Arlington, Texas, 76010, United States

Location

Related Publications (1)

• 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.

  PMID: 36099282 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Yue Liao, MPH, PhD

  University of Texas at Arlington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 5, 2022
• Study Start: March 29, 2023
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)