NCT04321317

Brief Summary

Anorexia nervosa is a severe cause of undernutrition. It leads to a dramatic decrease of weight with an important modification of the body composition. During the renutrition phase, disharmonious body composition recovery is a relapse factor. Dual X-ray absorptiometry (DXA) is the gold standard to study body composition in children with anorexia nervosa. But, due to technical limits, DXA analysis needs to take in account a potential failure to thrive with an adjustment on height. Moreover DXA needs an irradiation which does not allow close repeat measurements. Since several years, a simple, non-invasive, non-irradiant method for measure of body composition has been developed in pediatrics: the air displacement plethysmography (ADP). Actually, only one device is available for this measurement: the BodPod®. However, feasibility and accuracy of ADP compare to DXA have not been evaluated in pediatric anorexia nervosa. The aim of this study is to compare the accuracy of BodPod® compare to DXA in girls with anorexia nervosa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

March 23, 2020

Last Update Submit

April 1, 2025

Conditions

Anorexia Nervosa

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Air Displacement Plethysmography (ADP) for body fat mass measurement

    The accuracy of Air Displacement Plethysmography (ADP) will be compare to Dual X-ray Absorptiometry (DXA) according to the percentage of body fat mass measurement. The hypothesis will be validating if difference in percentage in body fat mass between ADP and DXA is below the 4%. The measurement will be done two times at 1 year interval

    1 year

Secondary Outcomes (3)

  • Acceptability of Air Displacement Plethysmography (ADP) by the patient compared to Dual X-ray Absorptiometry (DXA)

    1 year

  • Accuracy of Air Displacement Plethysmography (ADP) compare to Bio Electrical Impedance (BEI)

    1 year

  • Longitudinal evolution of the percentage of body fat mass

    1 year

Study Arms (1)

Undernourished Patients

OTHER

All patients included will be included in the unique arm of the study

Other: Measure of body composition by Air Displacement Plethysmography (ADP)

Interventions

Measure of body composition by Air Displacement Plethysmography (ADP)OTHER

Each patient included will have one measure of body composition by Air Displacement Plethysmography (ADP) during the initial consultation in the referent center for food disorders of Lyon and one year later.

Undernourished Patients

Eligibility Criteria

Age8 Years - 18 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female patients aged between 8 and 18 years
  • Female with a diagnosis of anorexia nervosa according to the DSM V classification, restrictive type or hyperphagic / purgative access type, evolving for less than 3 years.
  • Female who received explanations adapted to their level of understanding for this study
  • Female who expressed their consent to participate to this study
  • Female whose parents or holders of parental authority have been informed and signed free and informed consent
  • Female affiliated to a social security scheme

You may not qualify if:

  • Patients with psychotic symptoms
  • Patients with claustrophobia
  • Patients with severe respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon

Bron, 69677, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

April 19, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

April 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)