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A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities for Overweight and Obese People (eMouve3)

Primary Purpose

Obesity, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Controlled conditions
Free-living conditions
Sponsored by
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring obesity, energy expenditure, daily living physical activity, smartphone, accelerometry, prediction algorithm

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • men and women
  • age: 18-60 years
  • BMI between 28 and 42 kg/m²
  • subject considered as healthy after clinical examination and medical questionnaire
  • no pregnant women
  • subject with normal rest electrocardiogram (validated by a cardiologist)
  • certificate of non-indication against the practice of exercise stress testing delivered by a physician
  • 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
  • non-indication against the practice of exercise stress testing
  • 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

Sites / Locations

  • Centre de Recherche en Nutrition Humaine d'Auvergne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Controlled conditions

Free-living conditions

Arm Description

Volunteers were asked to perform several activities such as walking at different paces, running, sitting, standing still or taking public transportation for about 1h30 They wore 3 research sensors that estimated energy expenditure: Fitmate, Armband and Actiheart. They also wore smartphones (in front pant pockets) that collected accelerometry data.

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

Outcomes

Primary Outcome Measures

Accelerometry
Measures acquired by smartphones including a tri-axial accelerometer

Secondary Outcome Measures

Energy expenditure
Sensor: Fitmate
Energy expenditure
Sensor: Armband
Energy expenditure
Sensor: Actiheart

Full Information

First Posted
September 26, 2014
Last Updated
January 22, 2015
Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Almerys
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1. Study Identification

Unique Protocol Identification Number
NCT02348554
Brief Title
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities for Overweight and Obese People
Acronym
eMouve3
Official Title
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions for Overweight and Obese People (eMouve3)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborators
Almerys

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study was to validate functions for estimating energy expenditure in controlled and free-living conditions. This method was based on accelerometry data acquired from smartphones worn in a trouser pocket. The developed functions have been compared to the estimations provided by three research devices named Fitmate, Armband and Actiheart.
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. Two previous studies allowed to propose a function named PredEE, which has been tested on normal-weighted volunteers. This EE estimation function has been tested and improved with data collected from 43 overweight volunteers equipped with smartphones and two or three research sensors (Fitmate, Armband and Actiheart in controlled conditions, and Armband and Actiheart in free-living conditions). Research sensors' data serves as reference during the evaluation and improvement of the proposed function. This EE estimation function using the smartphone technology is dedicated to light- and moderate-intensity activities, and the investigators believe it can be a new way to help people controlling their daily physical activity level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Physical Activity
Keywords
obesity, energy expenditure, daily living physical activity, smartphone, accelerometry, prediction algorithm

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controlled conditions
Arm Type
Experimental
Arm Description
Volunteers were asked to perform several activities such as walking at different paces, running, sitting, standing still or taking public transportation for about 1h30 They wore 3 research sensors that estimated energy expenditure: Fitmate, Armband and Actiheart. They also wore smartphones (in front pant pockets) that collected accelerometry data.
Arm Title
Free-living conditions
Arm Type
Experimental
Arm Description
Volunteers were asked to wear sensors during about 12 hours, one day. They wore 2 research sensors that estimated energy expenditure: Armband and Actiheart. They also wore smartphones (in front pant pockets) that collected accelerometry data.
Intervention Type
Behavioral
Intervention Name(s)
Controlled conditions
Intervention Description
The 13 volunteers in controlled conditions performed each of the nine activities several times according to the activity scenario: sitting, slow, normal and brisk walking, climbing and descending stairs (eight floors), standing, slow running and taking public transportation (tramway). The duration of each activity varied from 2 to 20 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Free-living conditions
Intervention Description
The spontaneous activities of 30 volunteers were recorded in the free-living conditions for a full day selected either during the week or the weekend.
Primary Outcome Measure Information:
Title
Accelerometry
Description
Measures acquired by smartphones including a tri-axial accelerometer
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Energy expenditure
Description
Sensor: Fitmate
Time Frame
1 day
Title
Energy expenditure
Description
Sensor: Armband
Time Frame
1 day
Title
Energy expenditure
Description
Sensor: Actiheart
Time Frame
1 day
Other Pre-specified Outcome Measures:
Title
Rest energy expenditure
Description
Measurement of rest energy expenditure under canopy by Fitmate
Time Frame
1 day
Title
Rest energy expenditure
Description
Measurement of rest energy expenditure by using Armband
Time Frame
1 day
Title
Rest energy expenditure
Description
Measurement of rest energy expenditure by using Actiheart
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: men and women age: 18-60 years BMI between 28 and 42 kg/m² subject considered as healthy after clinical examination and medical questionnaire no pregnant women subject with normal rest electrocardiogram (validated by a cardiologist) certificate of non-indication against the practice of exercise stress testing delivered by a physician 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 non-indication against the practice of exercise stress testing 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Duclos, Physician
Organizational Affiliation
CHU G Montpied
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche en Nutrition Humaine d'Auvergne
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25141769
Citation
Rousset S, Fardet A, Lacomme P, Normand S, Montaurier C, Boirie Y, Morio B. Comparison of total energy expenditure assessed by two devices in controlled and free-living conditions. Eur J Sport Sci. 2015;15(5):391-9. doi: 10.1080/17461391.2014.949309. Epub 2014 Aug 21.
Results Reference
background
PubMed Identifier
25048352
Citation
Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudiere N, Manenq PH, Paris L, Ren L, Rousset S. A smartphone-driven methodology for estimating physical activities and energy expenditure in free living conditions. J Biomed Inform. 2014 Dec;52:271-8. doi: 10.1016/j.jbi.2014.07.009. Epub 2014 Jul 15.
Results Reference
background
Links:
URL
http://activcollector.clermont.inra.fr/home
Description
the site ActivCollector collects and processes accelerometry data sent by the smartphones, and then ActivCollector sends the EE and activity durations results to the smartphone's user

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A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities for Overweight and Obese People

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