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OpenTrials
Completed

NCT Number: NCT04321317

Validation of BodPod in Pediatric 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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

8 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: 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

  3. Longitudinal evolution of the percentage of body fat mass

    Time frame: 1 year

    The evolution of the percentage of body fat mass will be evaluated after 1 year of evolution.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PADAAM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2020
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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