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ObeseNCT03235583

MOTIONPODTM Validation in Free-living Conditio

A study testing MOTIONPODTM device validation in people with Obese and Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the investigators propose to assess the validity in measuring physical activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope) with an automatic activity/posture recognition algorithm… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obese, Healthy Volunteers
What is being tested?
MOTIONPODTM device validation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteFrance
Study dates
2 Apr 2012to 11 Oct 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male and female subjects
  • Age : 18 to 75 years
  • Patients or healthy volunteers
  • 40 obese subjects (BMI ≥ 30 kg/m2), 40 non-obese (BMI <30 kg/m2) and active (PA level evaluated by the RPAQ questionnaire) subjects, 40 non-obese and sedentary subjects
  • Absence of cardiac rate disorders

Who cannot join

  • Subjects with acute disorders: cardiovascular or neoplastic, severe infection during 3 previous months
  • Subjects with a pathology restricting the walking distance (confinement, distance <200 meters)
  • Subjects with implants (Pacemaker, cardiac implant or another active implant)
  • Claustrophobic subjects (for subjects participating to "doubly labelled water" protocol)
  • Drug use that could affect energy expenditure

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre de Recherche en Nutrition Humaine Rhône-Alpes - Centre hospitalier Lyon Sud

    Pierre-Bénite, 69310

Other trials in France

About this study

Official title: Validation of MotionPODTM a Device for Measuring Physical Activity, in Free-living Conditions

In this study, the investigators propose to assess the validity in measuring physical activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope) with an automatic activity/posture recognition algorithm and an activity-specific multilinear prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns will be compared to those of two existing activity or movement monitors: the triaxial accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the cost of a calibration of the heart-rate/EE relationship that limits its use in large population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years of both gender and with broad range of body mass index and physical activity level. The subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total of 14 days in everyday life conditions and complete a physical activity diary. In half of the subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW. The other 60 subjects will be studied twice, one month apart, to test the reproducibility of the measures.

Being tested
MOTIONPODTM device validation
Keywords
Energy expenditure, physical activity, accelerometer, magnetometer, monitoring, free-living conditions, doubly labelled water
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOTIONPODTM device validationDevice

    MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method

Study groups in NCT03235583
Study groupRoleWhat they receive
MotionPod ValidationOtherMedical device validation
Receives: Device: MOTIONPODTM device validation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Daily physical activity energy expenditure (PAEE) MOTIONPODTM prediction

    MotionPodTM predictions will be calculated with the newly developed algorithms to evaluate the concordance between the physical activity energy expenditure (PAEE) estimated by the MOTIONPODTM and that of 2 physical activity monitors: the Actigraph GT3X+TM and the ActiheartTM. The estimation of PAEE by MotionPodTM will be compared with the measure of PAEE by DLW (gold standard measure, primary outcome 2/), with the measure of PAEE by Actiheart TM (primary outcome 3/), and with the measure of PAEE by ActigraphGT3X+ TM (primary outcome 4/).

    Measured: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)

  2. Daily physical activity energy expenditure (PAEE) using DLW (gold standard measure) (modality A)

    Daily Total Energy Expenditure (TEE) and PAEE standards will be measured with the DLW reference method. Briefly Resting metabolic Rate (RMR) will be measured via indirect calorimetry using a ventilated open-hood metabolic cart after a 12h-overnight fast. TEE will be determined using a 14-day multipoint DLW protocol. After providing a baseline urine sample, subjects will ingest a premixed dose of H218O (10% enriched) and 2H2O (99.85% enriched) DLW. Equilibration will be assessed in urine samples collected at 4h and 5h post dose. Subsequent urine samples will be collected every two days of the 14 days of the protocol. 2H2 and 18O isotopic enrichment will be analyzed in quadruplicate by pyrolysis on an elemental analyzer (Flash HT; ThermoFisher) interfaced with an IRMS (Delta V, ThermoFisher).

    Measured: PAEE measurement will be measured over the 14-day study-period (Modality A)

  3. Daily physical activity energy expenditure (PAEE) Actiheart TM estimates (modalities A & B)

    ActiheartTM PAEE predictions will be calculated using the Actiheart software.

    Measured: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)

  4. Daily physical activity energy expenditure (PAEE) ActigraphGT3X+ TM estimates (modalities A & B)

    ActigraphGT3X+TM PAEE predictions will be calculated using the ActigraphGT3X+ TM software.

    Measured: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)

Secondary outcomes (3)

  1. Identification and classification of activity/posture patterns by the MOTIONPODTM device (assessed by confusion matrices)

    Different activities corresponding to the activity/recognition algorithm will be identified and quantified using the activity diary. The recognition rate of activity typologies (lying, sitting, inactive standing, active standing, walking, biking) by the MOTIONPODTM will be compared to data of the physical activity diary (measures (secondary measure outcome 2/). Confusion matrices will be used to compare the diary measures (secondary measure outcome 2/) with the MOTIONPODTM outputs.

    Measured: PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)

  2. Identification and classification of activities/postures patterns collected in the activity diary

    Different activities corresponding to the activity/recognition algorithm will be identified and quantified using the activity diary.

    Measured: PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B)

  3. (BMI < or > 30 kg/m2).

    to evaluate de concordance of MOTIONPODTM predictions with standard measure according to activity level, as previously described by subgroups

    Measured: Baseline (at inclusion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2017
  2. Study start2 Apr 2012
  3. Primary completion11 Oct 2013
  4. Study completion11 Oct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03235583
Sponsor's protocol ID
2011.702
Status last verified
Jul 2017
First submitted
28 Jul 2017
Last updated
4 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MOTIONPODTM device validation in people with Obese and Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily physical activity energy expenditure (PAEE) MOTIONPODTM prediction (time frame: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03235583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.

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