NCT02348554

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

September 26, 2014

Last Update Submit

January 22, 2015

Conditions

Keywords

obesityenergy expendituredaily living physical activitysmartphoneaccelerometryprediction algorithm

Outcome Measures

Primary Outcomes (1)

  • Accelerometry

    Measures acquired by smartphones including a tri-axial accelerometer

    1 day

Secondary Outcomes (3)

  • Energy expenditure

    1 day

  • Energy expenditure

    1 day

  • Energy expenditure

    1 day

Other Outcomes (3)

  • Rest energy expenditure

    1 day

  • Rest energy expenditure

    1 day

  • Rest energy expenditure

    1 day

Study Arms (2)

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.

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.

Behavioral: Free-living conditions

Interventions

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.

Controlled 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.

Free-living conditions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Nutrition Humaine d'Auvergne

Clermont-Ferrand, 63000, France

Location

Related Publications (2)

  • 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.

    PMID: 25141769BACKGROUND
  • Guidoux 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.

    PMID: 25048352BACKGROUND

Related Links

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Martine Duclos, Physician

    CHU G Montpied

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

September 26, 2014

First Posted

January 28, 2015

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

August 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations