NCT05736302 · University of Wisconsin, Milwaukee
Validating a New Machine-Learned Accelerometer Algorithm Using Doubly Labeled Water
(ValiDLW)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Doubly-Labeled Water
All eligible participants will receive a dose of doubly-labeled water.
Primary outcome measures
Accuracy of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).
Time frame: 8-10 days monitoring
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.
Precision of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).
Time frame: 8-10 days monitoring
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.
Total Daily Energy Expenditure (TDEE) (via DLW)
Time frame: pre-dose; 4 hours and 5 hours post-dose, and 8-10 days post-dose
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Milwaukee, Wisconsin
Collaborators
University of Colorado, Denver, University of Massachusetts, Amherst, National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations