Obesity Clinical Trial
— eMouve3Official title:
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions for Overweight and Obese People (eMouve3)
Verified date | January 2015 |
Source | Institut National de la Recherche Agronomique |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | August 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
France | Centre de Recherche en Nutrition Humaine d'Auvergne | Clermont Ferrand |
Lead Sponsor | Collaborator |
---|---|
Institut National de la Recherche Agronomique | Almerys |
France,
Guidoux R, Duclos M, Fleury G, Lacomme P, Lamaudière 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rest energy expenditure | Measurement of rest energy expenditure under canopy by Fitmate | 1 day | No |
Other | Rest energy expenditure | Measurement of rest energy expenditure by using Armband | 1 day | No |
Other | Rest energy expenditure | Measurement of rest energy expenditure by using Actiheart | 1 day | No |
Primary | Accelerometry | Measures acquired by smartphones including a tri-axial accelerometer | 1 day | No |
Secondary | Energy expenditure | Sensor: Fitmate | 1 day | No |
Secondary | Energy expenditure | Sensor: Armband | 1 day | No |
Secondary | Energy expenditure | Sensor: Actiheart | 1 day | No |
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