Validation of BodPod in Pediatric Anorexia Nervosa

NCT ID: NCT04321317

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2023-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Undernourished Patients

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

Group Type OTHER

Measure of body composition by Air Displacement Plethysmography (ADP)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL20_0120

Identifier Type: -

Identifier Source: org_study_id

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