Validating a New Machine-Learned Accelerometer Algorithm Using Doubly Labeled Water
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Milwaukee
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults 18+ years of age
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Doubly-Labeled Water
Other interventionAll eligible participants will receive a dose of doubly-labeled water.
Treatment groups
125 Participants
are divided into 3 treatment groupsGroup A: Individuals without movement limitations1 intervention
Group B: Individuals with impaired movement1 intervention
Group C: Individuals with impaired movement who are functionally impaired1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8-10 days monitoring2
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.
Time frame
8-10 days monitoring3
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.
Time frame
pre-dose; 4 hours and 5 hours post-dose, and 8-10 days post-doseSecondary outcomes
1
Resting Metabolic Rate (kcals/day)
Basal metabolic rate as determined by fasting RMR test, conducted via Parvomedics TrueOne 2400 Metabolic system. Results include the approximate number of calories an individual would expend if they spent the day in a resting state.
Time frame
pre-dose2
Fat free body mass (g)
Dual x-ray absorptiometry (DEXA) measurement of body composition, conducted via a Hologic Horizon W system. Results include the amount of fat, bone mineral density, and fat free mass, measured in grams. The fat free mass measurement is used to calculate the dose of doubly labeled water for the participant.
Time frame
7-14 days before dose3
Modified Physical Performance Test (MPPT)
The modified physical performance test consists of 9 subtests that are used to assess level of physical function. Total scores range from 0-36. Not frail = 32-36, Mildly frail = 25-31, Moderately frail = 17-24, and less than 17= low function.
Time frame
7-14 days before dose4
Maximum hand grip strength
Hand grip is measured via a hand grip dynamometer manufactured by Lafayette Instruments, and is equivalent to the Jamar hand grip dynamometer. The results are measured in lbs, and can range from 0 lbs to 250 lbs. Cut offs for normal hand grip strength vary significantly dependent upon age, sex, country of origin, and BMI. Lower hand grip strength is associated with lower physical function.
Time frame
7-14 days before doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Milwaukee
Lead sponsor
University of Colorado, Denver
Collaborator
University of Massachusetts, Amherst
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov