ObesityeMouve3NCT02348554
A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities for Overweight and Obese People
A study testing Free-living conditions in people with Obesity and Physical Activity, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity
- What is being tested?
- Free-living conditions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine d'Auvergne
Clermont-Ferrand, 63000
About this study
Official title: A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions for Overweight and Obese People (eMouve3)
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.
Read the 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.
- Conditions
- Obesity, Physical Activity
- Being tested
- Controlled conditions, Free-living conditions
- Keywords
- obesity, energy expenditure, daily living physical activity, smartphone, accelerometry, prediction algorithm
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled conditionsBehavioural
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 conditionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Controlled conditions | Experimental | 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. Receives: Behavioral: Controlled conditions |
| Free-living conditions | Experimental | 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. Receives: Behavioral: Free-living conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometry
Measures acquired by smartphones including a tri-axial accelerometer
Measured: 1 day
Secondary outcomes (3)
Energy expenditure
Sensor: Fitmate
Measured: 1 day
Energy expenditure
Sensor: Armband
Measured: 1 day
Energy expenditure
Sensor: Actiheart
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Sponsor type
- University, hospital or other
- Collaborators
- Almerys
- Responsible party
- Principal investigator, Martine DUCLOS, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Martine Duclos, Physician, Principal investigator, CHU G Montpied
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348554
- Sponsor's protocol ID
- AU1070
- Other IDs
- 2013-A01140-45
- Acronym
- eMouve3
- Status last verified
- Jan 2015
- First submitted
- 26 Sep 2014
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25141769Guidoux 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.
PubMed 25048352
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smartphone Application to Evaluate Energy Expenditure and Duration of Activities in Free-living Conditions for Overweight and Obese People (eMouve3)
- ClinicalTrials.gov ID
- NCT02348554
- Acronym / sponsor ID
- eMouve3 / AU1070
- Conditions
- Obesity, Physical Activity
- Keywords
- obesity, energy expenditure, daily living physical activity, smartphone, accelerometry, prediction algorithm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Almerys
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled conditions | Experimental | Behavioral: Controlled conditionsVolunteers 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. |
| Free-living conditions | Experimental | Behavioral: Free-living conditionsVolunteers 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled conditionsThe 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. | Behavioural | Controlled conditions |
| Free-living conditionsThe spontaneous activities of 30 volunteers were recorded in the free-living conditions for a full day selected either during the week or the weekend. | Behavioural | Free-living conditions |
Primary outcome
Accelerometry
Time frame: 1 day
Measures acquired by smartphones including a tri-axial accelerometer
3 secondary outcomes
Energy expenditure
Time frame: 1 day
Energy expenditure
Time frame: 1 day
Energy expenditure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Background: PubMed 25141769Rousset 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.
- Background: PubMed 25048352Guidoux 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.
- 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 userLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Duclos, Physician principal investigator
CHU G Montpied
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free-living conditions in people with Obesity and Physical Activity, run by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometry (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02348554, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.