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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995253
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Collaborator:
Almerys
Information provided by (Responsible Party):
Martine DUCLOS, University Hospital, Clermont-Ferrand

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
The Focus of the Study Was to Estimate Energy Expenditure Thanks to Accelerometry Data Collected by a Smartphone. Device: Energy expenditure estimation in controlled conditions Device: Energy expenditure estimation in free-living conditions Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities
Study Start Date : September 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : October 2013
Arms and Interventions
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Arm Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Energy expenditure [ Time Frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions ]
    Sensor: Armband

  2. Energy expenditure [ Time Frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions ]
    Sensor: Actiheart


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995253


Locations
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France
Centre de Recherche en Nutrition Humaine Auvergne
Clermont Ferrand, France, 63000
Sponsors and Collaborators
Institut National de la Recherche Agronomique
Almerys
More Information
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Responsible Party: Martine DUCLOS, PUPH, University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01995253    
Other Study ID Numbers: AU979
2012-A00809-34 ( Other Identifier: ANSM )
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013