AccelerometryNCT01995253
A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities
A study testing Energy expenditure estimation in free-living conditions in people with Accelerometry, 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 find functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone 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
- Accelerometry
- What is being tested?
- Energy expenditure estimation in free-living conditions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Oct 2013
- 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 18.5 and 25 kg/m²
- subject considered as healthy after clinical examination and medical questionnaire
- women of childbearing age: negative beta-HCG
- subject with normal rest electrocardiogram (validated by a cardiologist)
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- 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
- 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
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- 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 Auvergne
Clermont-Ferrand, 63000
About this study
The aim of this study was to find functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named 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.
Thus, the proposed EE estimation function has been created using accelerometry data collected from 10 volunteers equipped with a smartphone and two research sensors (Armband and Actiheart) used to estimate EE during several controlled activities. The research sensors' data serves as reference during the creation and evaluation of the proposed function.
It has been evaluated with data of 6 other volunteers in free-living conditions. This new EE function using the smartphone technology is dedicated to light- and moderate-intensity activities, and we believe it can be a new way to help people controlling their daily physical activity level.
- Conditions
- Accelerometry
- Being tested
- Energy expenditure estimation in controlled conditions, Energy expenditure estimation in free-living conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy expenditure estimation in controlled conditionsDevice
Volunteers were asked to perform several activities such as walking at different paces, running, sitting, standing still or taking public transportation for about 3h30 They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.
Energy expenditure estimation in free-living conditionsDevice
Volunteers were asked to wear sensors during about 12 hours, one day. They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.
| Study group | Role | What they receive |
|---|---|---|
| Controlled conditions | Experimental | Not described Receives: Device: Energy expenditure estimation in controlled conditions |
| Free-living conditions | Experimental | Not described Receives: Device: Energy expenditure estimation in free-living conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometry
Measures acquired by a smartphone (it contains several sensors, including a tri-axial accelerometer)
Measured: about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)
Secondary outcomes (2)
Energy expenditure
Sensor: Armband
Measured: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
Energy expenditure
Sensor: Actiheart
Measured: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccelerometryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995253
- Sponsor's protocol ID
- AU979
- Other IDs
- 2012-A00809-34
- Status last verified
- Nov 2013
- First submitted
- 21 Nov 2013
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. 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 Moderate-intensity Activities
- ClinicalTrials.gov ID
- NCT01995253
- Acronym / sponsor ID
- AU979
- Conditions
- Accelerometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'EnvironnementUniversity, hospital or other
- Collaborators
- Almerys
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 26 Nov 2013 (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 find functions for estimating energy expenditure in free-living conditions. This method was based on accelerometry data acquired from a smartphone worn in a trouser pocket. The developed functions have been compared to the estimations provided by two research devices named 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.
Thus, the proposed EE estimation function has been created using accelerometry data collected from 10 volunteers equipped with a smartphone and two research sensors (Armband and Actiheart) used to estimate EE during several controlled activities. The research sensors' data serves as reference during the creation and evaluation of the proposed function.
It has been evaluated with data of 6 other volunteers in free-living conditions. This new EE function using the smartphone technology is dedicated to light- and moderate-intensity activities, and we believe it can be a new way to help people controlling their daily physical activity level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controlled conditions | Experimental | Device: Energy expenditure estimation in controlled conditions |
| Free-living conditions | Experimental | Device: Energy expenditure estimation in free-living conditions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- men and women
- age: 18-60 years
- BMI between 18.5 and 25 kg/m²
- subject considered as healthy after clinical examination and medical questionnaire
- women of childbearing age: negative beta-HCG
Key exclusion criteria (11 listed)
- respiratory failure or cardiovascular problem
- known cardiac decompensation or myocardial infarction
- surgery made less than 6 months before the study beginning
- pregnant women and nursing mother
- current infectious pathology
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 |
|---|---|---|
| Energy expenditure estimation in controlled conditionsVolunteers were asked to perform several activities such as walking at different paces, running, sitting, standing still or taking public transportation for about 3h30 They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data. | Device | Controlled conditions |
| Energy expenditure estimation in free-living conditionsVolunteers were asked to wear sensors during about 12 hours, one day. They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data. | Device | Free-living conditions |
Primary outcome
Accelerometry
Time frame: about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)
Measures acquired by a smartphone (it contains several sensors, including a tri-axial accelerometer)
2 secondary outcomes
Energy expenditure
Time frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
Energy expenditure
Time frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
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 3 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy expenditure estimation in free-living conditions in people with Accelerometry, 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 11 inclusion and 11 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 3 Apr 2024. 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: about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2024.