Anorexia NervosaPADAAMNCT04321317
Validation of BodPod in Pediatric Anorexia Nervosa
A study testing Measure of body composition by Air Displacement Plethysmography (ADP) in people with Anorexia Nervosa, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Measure of body composition by Air Displacement Plethysmography (ADP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients with psychotic symptoms
- Patients with claustrophobia
- Patients with severe respiratory disease
Trial locations and contacts
1 site in 1 country.
France1 site
Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon) - Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon
Bron, 69677
About this study
Official title: 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Measure of body composition by Air Displacement Plethysmography (ADP)
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Undernourished Patients | Other | All patients included will be included in the unique arm of the study Receives: Other: Measure of body composition by Air Displacement Plethysmography (ADP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start19 Apr 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321317
- Sponsor's protocol ID
- 69HCL20_0120
- Acronym
- PADAAM
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Air Displacement Plethysmography Compare to Dual X-ray Absorptiometry (DXA) in Girls With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT04321317
- Acronym / sponsor ID
- PADAAM / 69HCL20_0120
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Undernourished Patients | Other | Other: Measure of body composition by Air Displacement Plethysmography (ADP)All patients included will be included in the unique arm of the study |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with psychotic symptoms
- Patients with claustrophobia
- Patients with severe respiratory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Undernourished Patients |
Primary outcome
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
3 secondary outcomes
Acceptability of Air Displacement Plethysmography (ADP) by the patient compared to Dual X-ray Absorptiometry (DXA)
Time frame: 1 year
Accuracy of Air Displacement Plethysmography (ADP) compare to Bio Electrical Impedance (BEI)
Time frame: 1 year
Longitudinal evolution of the percentage of body fat mass
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of body composition by Air Displacement Plethysmography (ADP) in people with Anorexia Nervosa, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Air Displacement Plethysmography (ADP) for body fat mass measurement (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.