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CompletedNCT01995253Updated Apr 3, 2024

A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities

An interventional study of Energy expenditure estimation in controlled conditions and Energy expenditure estimation in free-living conditions in Accelerometry, sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The aim of this study was to find functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.

Read the detailed description

There is a growing interest in evaluating physical activity and energy expenditure (EE) to provide feedback to the user. The use of mass-market sensors such as accelerometers offers a promising solution for the general public due to the growing smartphone market over the last decade.

Thus, the proposed EE estimation function has been created using accelerometry data collected from 10 volunteers equipped with a smartphone and two research sensors (Armband and Actiheart) used to estimate EE during several controlled activities. The research sensors' data serves as reference during the creation and evaluation of the proposed function.

It has been evaluated with data of 6 other volunteers in free-living conditions. This new EE function using the smartphone technology is dedicated to light- and moderate-intensity activities, and we believe it can be a new way to help people controlling their daily physical activity level.

02

Conditions studied

  • Accelerometry
03

In context

Lead sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement is the lead sponsor of 50 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • men and women
  • age: 18-60 years
  • BMI between 18.5 and 25 kg/m²
  • subject considered as healthy after clinical examination and medical questionnaire
  • women of childbearing age: negative beta-HCG
  • subject with normal rest electrocardiogram (validated by a cardiologist)
  • subject with normal blood pressure (\<140/90 mm Hg) with or without medical treatment
  • subject with no foot pad problem
  • subject giving his/her written informed consent
  • subject willing to comply with study procedures
  • affiliated to National Health Insurance

Exclusion criteria

Exclusion Criteria:

  • respiratory failure or cardiovascular problem
  • known cardiac decompensation or myocardial infarction
  • surgery made less than 6 months before the study beginning
  • pregnant women and nursing mother
  • current infectious pathology
  • abnormal electrocardiogram
  • not affiliated to national health insurance people
  • under legal guardianship
  • refusal to sign informed consent
  • refusal to be registered on the national volunteers data file
  • currently participating or who having got 4500€ in this year before to have participated in another clinical trial
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Controlled conditions

    Device: Energy expenditure estimation in controlled conditions

  • Experimental
    Free-living conditions

    Device: Energy expenditure estimation in free-living conditions

Interventions

  • DeviceEnergy expenditure estimation in controlled conditions

    Volunteers were asked to perform several activities such as walking at different paces, running, sitting, standing still or taking public transportation for about 3h30 They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.

  • DeviceEnergy expenditure estimation in free-living conditions

    Volunteers were asked to wear sensors during about 12 hours, one day. They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.

06

What researchers measure

Primary outcomes

  1. Accelerometry

    Measures acquired by a smartphone (it contains several sensors, including a tri-axial accelerometer)

    Time frame: about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)

Secondary outcomes

  1. Energy expenditure

    Sensor: Armband

    Time frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions

  2. Energy expenditure

    Sensor: Actiheart

    Time frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions

07

Study locations

1 site
  • Centre de Recherche en Nutrition Humaine Auvergne
    Clermont-Ferrand, 63000, France
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012, a primary completion of Nov 2012 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2013
First posted
Nov 26, 2013
Start
Sep 2012
Primary completionActual
Nov 2012
CompletionActual
Oct 2013
Last update
Apr 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01995253
Lead sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Almerys
Responsible party
Martine DUCLOS (PUPH, University Hospital, Clermont-Ferrand) — Principal investigator
First posted
Nov 26, 2013
Start date
Sep 2012
Primary completion
Nov 2012
Completion
Oct 2013
Last update
Apr 3, 2024

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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