NCT01995253

Brief 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. The developed functions have been compared to the estimations provided by two research devices named Armband and Actiheart.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

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

September 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
Last Updated

April 3, 2024

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

November 21, 2013

Last Update Submit

April 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accelerometry

    Measures acquired by a smartphone (it contains several sensors, including a tri-axial accelerometer)

    about 17Hz (duration: 3h30 in controlled conditions; 12 hours in free-living conditions)

Secondary Outcomes (2)

  • Energy expenditure

    one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions

  • Energy expenditure

    one point recorded each minute for 3h30 in controlled conditions or 12 hours in free-living conditions

Study Arms (2)

Controlled conditions

EXPERIMENTAL
Device: Energy expenditure estimation in controlled conditions

Free-living conditions

EXPERIMENTAL
Device: Energy expenditure estimation in free-living conditions

Interventions

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.

Controlled conditions

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.

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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche en Nutrition Humaine Auvergne

Clermont-Ferrand, 63000, France

Location

Study Design

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

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 26, 2013

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

October 1, 2013

Last Updated

April 3, 2024

Record last verified: 2013-11

Locations