Validation of BodPod in Pediatric Anorexia Nervosa (PADAAM)
Primary Purpose
Anorexia Nervosa
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Measure of body composition by Air Displacement Plethysmography (ADP)
Sponsored by
About this trial
This is an interventional other trial for Anorexia Nervosa
Eligibility Criteria
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
Sites / Locations
- Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Undernourished Patients
Arm Description
All patients included will be included in the unique arm of the study
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04321317
Brief Title
Validation of BodPod in Pediatric Anorexia Nervosa
Acronym
PADAAM
Official Title
Accuracy of Air Displacement Plethysmography Compare to Dual X-ray Absorptiometry (DXA) in Girls With Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Undernourished Patients
Arm Type
Other
Arm Description
All patients included will be included in the unique arm of the study
Intervention Type
Other
Intervention Name(s)
Measure of body composition by Air Displacement Plethysmography (ADP)
Intervention Description
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 Outcome Measure Information:
Title
Accuracy of Air Displacement Plethysmography (ADP) for body fat mass measurement
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Acceptability of Air Displacement Plethysmography (ADP) by the patient compared to Dual X-ray Absorptiometry (DXA)
Description
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
Time Frame
1 year
Title
Accuracy of Air Displacement Plethysmography (ADP) compare to Bio Electrical Impedance (BEI)
Description
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
Time Frame
1 year
Title
Longitudinal evolution of the percentage of body fat mass
Description
The evolution of the percentage of body fat mass will be evaluated after 1 year of evolution.
Time Frame
1 year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diane MORFIN, Dr
Phone
04.27.85.60.11
Ext
+33
Email
diane.morfin@chu-lyon.fr
Facility Information:
Facility Name
Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane MORFIN, Dr
Phone
04.27.85.60.11
Ext
+33
Email
diane.morfin@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Diane MORFIN, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation of BodPod in Pediatric Anorexia Nervosa
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