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

April 1, 2024 updated by: Martine DUCLOS, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France, 63000
        • Centre de Recherche en Nutrition Humaine Auvergne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Free-living conditions
Device: Energy 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.
Experimental: Controlled conditions
Device: Energy 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accelerometry
Time Frame: about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)
Measures acquired by a smartphone (it contains several sensors, including a tri-axial accelerometer)
about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Energy expenditure
Time Frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
Sensor: Armband
one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
Energy expenditure
Time Frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
Sensor: Actiheart
one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Almerys

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AU979
  • 2012-A00809-34 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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