Validating a New Algorithm for Energy Expenditure in Movement Disorders

This observational study aims to check how accurately a new computer program (machine-learned accelerometer algorithm) can estimate the total daily energy your body uses (Total Daily Energy Expenditure or TDEE). This new program is designed for people with movement difficulties, as current programs aren't very accurate for them. You would receive a special drink called Doubly-Labeled Water, which helps measure your energy use. Researchers will compare the energy estimates from the new program with measurements from the Doubly-Labeled Water. The study is looking for about 125 adults who can walk on their own, speak English, and have a smartphone and internet access. The goal is to create a better tool for future research on physical activity for people with movement limitations. The current recruitment status is unclear.

Study design
This is an observational study involving approximately 125 adult participants. It is not a randomized or blinded study.
What's involved
You would attend three study visits. These visits include physical function tests, a body composition scan (DXA), a resting metabolic rate exam, consuming Doubly-Labeled Water, and providing urine and saliva samples. You will also wear an accelerometer for 8-10 days.
Compensation
Not stated in the trial record.
Follow-up
Your energy expenditure will be measured at pre-dose, 4 and 5 hours post-dose, and 8-10 days post-dose of the Doubly-Labeled Water.

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NCT05736302

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

Recruiting
Not specifiedAges 18+Observational
University of Wisconsin, Milwaukee
~125 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Doubly-Labeled Water

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of accelerometer derived estimations of total daily energy expenditure (TDEE, kcals/day).
Measured over 8-10 days monitoring
+2 more outcomes measured
Movement Disorders
Energy Metabolism
1 sites across 1 states
Wisconsin1
  • Scott Strath, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Milwaukee

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Eligibility criteria

Inclusion

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

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