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

NCT05736302 | Recruiting

• 2 other identifiers: 21.061R01CA215318
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Movement Disorders; Energy Metabolism

Keywords

Doubly labeled water (DLW); Total Daily Energy Expenditure (TDEE); Accelerometry

Outcome Measures

Primary Outcomes (3)

• Accuracy of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).

  Accelerometer estimations will be derived by different algorithms available in the literature, as well as from a newly developed algorithm that distinguishes between those with and without movement limitations. Accelerometer estimations of TDEE will be compared to those values obtained by the criterion doubly-labeled water technique.

  8-10 days monitoring

• Precision of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).

  Accelerometer estimations will be derived by different algorithms available in the literature, as well as from a newly developed algorithm that distinguishes between those with and without movement limitations. Accelerometer estimations of TDEE will be compared to those values obtained by the criterion doubly-labeled water technique.

  8-10 days monitoring

• Total Daily Energy Expenditure (TDEE) (via DLW)

  Total daily energy expenditure (TDEE) over the 8-10 day period as measured by the difference in presence of isotopes in the samples at Visit 3. The 18-O and deuterium exit the body through slightly different mechanisms, so when we examine the difference in levels present at the end of the 8-10 day period between Visit 2 and Visit 3, we can estimate carbon dioxide (CO2) production and hence, energy expenditure. The samples taken at Visit 2 provide the baseline information required to analyze the samples taken at Visit 3 and calculate TDEE.

  pre-dose; 4 hours and 5 hours post-dose, and 8-10 days post-dose

Secondary Outcomes (6)

• Resting Metabolic Rate (kcals/day)

  pre-dose

• Fat free body mass (g)

  7-14 days before dose

• Modified Physical Performance Test (MPPT)

  7-14 days before dose

• Maximum hand grip strength

  7-14 days before dose

• Gait speed

  7-14 days before dose

Study Arms (3)

Individuals without movement limitations

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

Other: Doubly-Labeled Water

Individuals with impaired movement

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

Other: 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.

Other: Doubly-Labeled Water

Interventions

Doubly-Labeled Water OTHER

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

Individuals with impaired movement; Individuals with impaired movement who are functionally impaired; Individuals without movement limitations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 18+ years of age

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead
• University of Colorado, Denver: collaborator
• University of Massachusetts, Amherst: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and Saliva- only retained until completion of data analysis, and then destroyed.

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Scott Strath, PhD

  University of Wisconsin, Milwaukee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine O'Connell Valuch

CONTACT

414-229-4115; oconnell@uwm.edu

Scott Strath, PhD

CONTACT

sstrath@uwm.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 21, 2023
• Study Start: March 14, 2023
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)