- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01995253
A Smartphone Application to Evaluate Energy Expenditure and Duration of Moderate-intensity Activities
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Clermont Ferrand, France, 63000
- Centre de Recherche en Nutrition Humaine Auvergne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- 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
- 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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Free-living conditions
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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.
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Experimental: Controlled conditions
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accelerometry
Time Frame: about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)
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Measures acquired by a smartphone (it contains several sensors, including a tri-axial accelerometer)
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about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure
Time Frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
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Sensor: Armband
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one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
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Energy expenditure
Time Frame: one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
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Sensor: Actiheart
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one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions
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Collaborators and Investigators
Collaborators
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AU979
- 2012-A00809-34 (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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