Validation of BodPod in Pediatric Anorexia Nervosa (PADAAM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anorexia Nervosa
• Intervention / Treatment: Other: Measure of body composition by Air Displacement Plethysmography (ADP)

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diane MORFIN, Dr; Phone Number: +33 04.27.85.60.11; Email: diane.morfin@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69677
    • Recruiting
    • Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
    • Contact: Diane MORFIN, Dr; Phone Number: +33 04.27.85.60.11; Email: diane.morfin@chu-lyon.fr
    • Principal Investigator: Diane MORFIN, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Air Displacement Plethysmography (ADP) by the patient compared to Dual X-ray Absorptiometry (DXA)	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	1 year
Accuracy of Air Displacement Plethysmography (ADP) compare to Bio Electrical Impedance (BEI)	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	1 year
Longitudinal evolution of the percentage of body fat mass	The evolution of the percentage of body fat mass will be evaluated after 1 year of evolution.	1 year

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: 69HCL20_0120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No