Validating a New Machine-Learned Accelerometer Algorithm Using Doubly Labeled Water

NCT ID: NCT05736302

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this study is to validate previously developed physical function-clustered specific machine-learned accelerometer algorithms to estimate total daily energy expenditure (TDEE) in individuals with general movement and functional limitations.

Detailed Description

Current algorithms for examining accelerometer data were developed primarily using data from individuals without movement limitations or impairments. As such, the current available analytic algorithms are inadequate for use with individuals with limitations and impairments to estimate total daily energy expenditure (TDEE). The creation of a new algorithm that can accurately assess TDEE in individuals with movement limitations will be beneficial for future research examining physical activity interventions targeted to these individuals. This study will serve to validate a new algorithm that was developed specifically to analyze accelerometer data for individuals with movement limitations, and gauge the accuracy of the new algorithm's ability to accurately assess TDEE against one of the gold standards of TDEE measurement, the doubly labelled water technique.

Approximately 125 adults, 50 from Colorado, and 75 from Wisconsin, will participate in this study. Participants will complete three study visits. During the first visit, physical function will be assessed during a series of tests, and a dual-energy X-ray absorptiometry (DXA) scan will be performed to obtain information on body composition. During the second visit, the participant will complete a resting metabolic rate (RMR) examination, will consume a dose of doubly labeled water, and will provide urine and saliva samples. At the end of the second visit, participants will be given a set of accelerometers to wear for 8-10 days, and will be asked to complete a wear log for documentation. After 8-10 days have passed, during the final visit, participants will provide additional urine samples and return the accelerometers.

The hypothesis being tested is that physical function-clustered specific machine-learned accelerometer algorithms will produce more accurate and precise estimations of TDEE during free-living compared with healthy population derived accelerometer algorithms applied to diverse populations.

Conditions

Movement Disorders; Energy Metabolism

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Individuals without movement limitations

Individuals who are not classified as impaired or functionally limited per results of physical function testing.

Doubly-Labeled Water

Intervention Type: OTHER

All eligible participants will receive a dose of doubly-labeled water.

Individuals with impaired movement

Individuals who are classified as impaired, but not functionally limited per results of physical function testing.

Doubly-Labeled Water

Intervention Type: OTHER

All eligible participants will receive a dose of doubly-labeled water.

Individuals with impaired movement who are functionally impaired

Individuals who are classified as impaired and functionally limited per results of physical function testing.

Doubly-Labeled Water

Intervention Type: OTHER

All eligible participants will receive a dose of doubly-labeled water.

Interventions

Doubly-Labeled Water

All eligible participants will receive a dose of doubly-labeled water.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• must be 18+ years of age
• be able to ambulate on own, unassisted, on a regular basis
• speak and read English
• must have access to a working smart phone and a computer with internet access

Exclusion Criteria

• wheelchair reliant
• assistive walking device reliant (cannot walk for at least 50 feet without an assistive device)
• diagnosed uncontrolled hypertension (above 160/100 mgHg)
• diagnosed cognitive impairment or inability to follow study procedures such as Alzheimer's disease or dementia
• cannot take metabolic altering medications
• cannot be pregnant
• cannot be breastfeeding
• cannot use supplemental oxygen
• cannot completed required study activities for any reason
• cannot have a resting heart rate > 100 bpm or a resting blood pressure > 160 mgHg during Visit 1
• cannot weigh more than 450 lbs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Wisconsin, Milwaukee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Strath, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Milwaukee

Locations

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Katharine O'Connell Valuch

Role: CONTACT

oconnell@uwm.edu

414-229-4115

Scott Strath, PhD

Role: CONTACT

sstrath@uwm.edu

Facility Contacts

Katharine O'Connell Valuch

Role: primary

Scott Strath

Role: backup

Other Identifiers

R01CA215318

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21.061

Identifier Type: -

Identifier Source: org_study_id