- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02348554
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities for Overweight and Obese People (eMouve3)
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions for Overweight and Obese People (eMouve3)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont Ferrand, France, 63000
- Centre de Récherche en Nutrition Humaine d'Auvergne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 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.
|
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.
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Experimental: Free-living conditions
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accelerometry
Time Frame: 1 day
|
Measures acquired by smartphones including a tri-axial accelerometer
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure
Time Frame: 1 day
|
Sensor: Fitmate
|
1 day
|
Energy expenditure
Time Frame: 1 day
|
Sensor: Armband
|
1 day
|
Energy expenditure
Time Frame: 1 day
|
Sensor: Actiheart
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rest energy expenditure
Time Frame: 1 day
|
Measurement of rest energy expenditure under canopy by Fitmate
|
1 day
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Rest energy expenditure
Time Frame: 1 day
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Measurement of rest energy expenditure by using Armband
|
1 day
|
Rest energy expenditure
Time Frame: 1 day
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Measurement of rest energy expenditure by using Actiheart
|
1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martine Duclos, Physician, CHU G Montpied
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AU1070
- 2013-A01140-45 (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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