PADAAM: Validation of BodPod in Pediatric Anorexia Nervosa

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04321317

Collaborator

(none)

Enrollment

Location

Arm

35.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Other: Measure of body composition by Air Displacement Plethysmography (ADP)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Accuracy of Air Displacement Plethysmography Compare to Dual X-ray Absorptiometry (DXA) in Girls With Anorexia Nervosa

Actual Study Start Date :

Apr 19, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Undernourished Patients All patients included will be included in the unique arm of the study	Other: Measure of body composition by Air Displacement Plethysmography (ADP) 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.

Arm

Intervention/Treatment

Other: Undernourished Patients

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

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

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.

Outcome Measures

Primary Outcome Measures

Accuracy of Air Displacement Plethysmography (ADP) for body fat mass measurement [1 year]
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

Secondary Outcome Measures

Acceptability of Air Displacement Plethysmography (ADP) by the patient compared to Dual X-ray Absorptiometry (DXA) [1 year]
The questionnaire includes 3 questions after the ADP using simple analog visual scales adapted to children comprehension. The measurement will be done two times at 1 year interval
Accuracy of Air Displacement Plethysmography (ADP) compare to Bio Electrical Impedance (BEI) [1 year]
The difference between percentage of body fat mass will quantified between ADP and BEI. The measurement will be done two times at 1 year interval
Longitudinal evolution of the percentage of body fat mass [1 year]
The evolution of the percentage of body fat mass will be evaluated after 1 year of evolution.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon	Bron		France	69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04321317

Other Study ID Numbers:

69HCL20_0120

First Posted:

Mar 25, 2020

Last Update Posted:

May 13, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anorexia

Anorexia Nervosa

Study Results

No Results Posted as of May 13, 2022