Study Stopped
Lack of patient responding to criteria
Sensory Workshops and Anorexia Nervosa
Prospective Evaluation of a Year of Therapeutic Impact Sensory Workshops on Body Mass Index in Anorexia Adolescent Mental
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
In the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 3, 2016
CompletedFirst Posted
Study publicly available on registry
June 8, 2016
CompletedJune 8, 2016
June 1, 2016
2.5 years
June 3, 2016
June 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the impact of sensory workshops on BMI Body Mass Indexat 6 months and 12 months
The primary endpoint is the M6 and increase maintenance M12 BMI Body Mass Index to \<or = 2.6kg / m2
Comparaison to baseline and 6 month after and maintenance at month 12
Study Arms (2)
Olfactory workshop + Somesthesia workshop
EXPERIMENTALOlfactory workshop, Twenty odorants. Somesthesia workshop, time for moving the body, Talk Time
Auditory workshop + Somesthesia workshop
EXPERIMENTALAuditory workshop, Twenty extracts of music tracks. Somesthesia workshop, time for moving the body, Talk Time
Interventions
Twenty odorants are selected: 10 evoke a food (including 5 pleasant and unpleasant 5) and 10 suggest a non-food source
Kinesthetic time or time for moving the body (30 min), and kinesthetic sensations (duration 10 min), and Talk Time
Twenty extracts of music tracks (30 seconds each) are built in the same fashion as those used during the workshops, but are different.
Eligibility Criteria
You may qualify if:
- Diagnosis of anorexia nervosa according to DMS IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria.
- Follow Outpatient care or hospitalization
- Able to respond to the clinical evaluation questionnaires
- Affiliated to the social security system
- Consentement Informed of the legal representative and the patient
You may not qualify if:
- Somatic comorbidity associated diabetes, celiac disease, brain tumor.
- Intolerance Odors, predisposition to develop asthma and / or respiratory allergies.
- Pathologie Chronic of nose and sinus.
- Hyposmic Or anosmic.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondation Lenvallead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florence ASKENAZY, MD
Fondation Lenval
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2016
First Posted
June 8, 2016
Study Start
September 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 8, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share