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

Obesity Clinical Trial

— eMouve3  

Official title:

A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions for Overweight and Obese People (eMouve3)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348554
• Other study ID #: AU1070
• Secondary ID: 2013-A01140-45
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: January 22, 2015
• Start date: October 2013
• Est. completion date: August 2014

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity
• Physical Activity

Intervention

Behavioral:
• Controlled conditions
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.
• Free-living conditions
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.

Locations

Country	Name	City	State
France	Centre de Recherche en Nutrition Humaine d'Auvergne	Clermont Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Recherche Agronomique	Almerys

Country where clinical trial is conducted

France, 

References & Publications (2)

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

Outcome

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

External Links

•   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