Plain English Summary
Background and study aims
Anorexia nervosa is an eating disorder in which people try to lose as much weight as possible, usually by a combination of restricting the amount of food that they eat, doing an excessive amount of exercise and by taking laxatives. Treatment for the condition typically involves psychological therapy and supervised weight gain. However, the amount of fat in the body (percentage body fat) after the anorexic has been restored to a healthy weight influences whether they are likely to relapse (become anorexic again). Females that have recently gained weight after being treated for anorexia nervosa tend to have body fat build up around the stomach and abdomen (central adiposity phenotype). This results in a pot belly appearance (abdominal protrusion) that may affect how the patient feels about her body shape and weight. This, in turn, could cause a relapse. However, there have been no studies to date that looks at how the central adiposity phenotype may affect the long-term clinical outcome for people with anorexia nervosa. Here, we want to see if there is a relationship between the total amount of body fat after treatment, and where that fat builds up in the body, with long-term prognosis for anorexia nervosa sufferers.
Who can participate?
Females aged between 18-45 and diagnosed with anorexia nervosa.
What does the study involve?
All participants receive inpatient cognitive behavioural therapy and undergo supervised weight gain. They all receive the same treatment.
What are the possible benefits and risks of participating?
The benefits are the improvement of physical, psychological and social status of patients. There is no risk in participating in the study.
Where is the study run from?
Villa Garda Hospital (Italy).
When is the study starting and how long is it expected to run for?
The study ran from January 2012 to January 2015.
Who is funding the study?
Villa Garda Hospital (Italy).
Who is the main contact?
Dr Marwan El Ghoch
marwan1979@hotmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Marwan El Ghoch
ORCID ID
Contact details
Monte Baldo Street
89
Garda
37016
Italy
+39 (0)456208611
marwan1979@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03
Study information
Scientific title
The relationship between body fat and long-term clinical outcome in anorexia nervosa: a longitudinal study
Acronym
Study hypothesis
The body composition assessed after immediate weight restoration achieved in inpatient treatment may influence clinical long-outcome in adult females with anorexia nervosa, namely lower percent total body fat and higher percent trunk fat, may predict long-term relapse.
Ethics approval
Institutional Review Board of Villa Garda Hospital, 15/12/2011, ref. 03_2012
Study design
Longitudinal study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.villagarda.it/Libretto%20DA.pdf (in Italian only)
Condition
Anorexia nervosa/body composition
Intervention
We recruited 55 female patients with a diagnosis of anorexia nervosa for an observational study. The interventions are weight restoration and inpatient cognitive behavioural therapy. All patients received the same treatment. Body composition was measured using dual-energy X-ray absorptiometry (DXA) in anorexia nervosa. The treatment last 20 weeks and comprises 13 weeks of inpatient therapy followed by 7 weeks of partial hospitalization. More over there was a 1 year follow-up after treatment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Assessing whether lower percent total body fat predict long-term relapse.
Clinical outcome was determined using:
1. Morgan-Russell criteria:
1.1. Full outcome: No DSM criteria for anorexia nervosa for a minimum of eight weeks
1.2. Good outcome: BMI ≥ 18.5 kg/m², normal menses, may have some binge eating or purging behavior or psychological symptoms of anorexia nervosa
1.3. Fair outcome: BMI ≥ 18.5 kg/m²; amenorrhea
1.4. Poor outcome: BMI < 18.5 kg/m²
2. Eating Disorder Examination Interview:
2.1. Full outcome: BMI ≥18.5 kg/m² and EDE total score < 1.74
2.2. Good outcome: BMI ≥ 18.5 kg/m²
2.3. Poor outcome: BMI < 18.5 kg/m²
*Outcome was dichotomized into 'full, good or fair' and 'poor'.
Evaluated at the end of one year follow-up.
Secondary outcome measures
Assessing whether higher percent trunk fat may predict long-term relapse.
Clinical outcome was determined using:
1. Morgan-Russell criteria:
1.1. Full outcome: No DSM criteria for anorexia nervosa for a minimum of eight weeks
1.2. Good outcome: BMI ≥ 18.5 kg/m², normal menses, may have some binge eating or purging behavior or psychological symptoms of anorexia nervosa
1.3. Fair outcome: BMI ≥ 18.5 kg/m²; amenorrhea
1.4. Poor outcome: BMI < 18.5 kg/m²
2. Eating Disorder Examination Interview:
2.1. Full outcome: BMI ≥18.5 kg/m² and EDE total score < 1.74
2.2. Good outcome: BMI ≥ 18.5 kg/m²
2.3. Poor outcome: BMI < 18.5 kg/m²
*Outcome was dichotomized into 'full, good or fair' and 'poor'.
Evaluated at the end of one year follow-up.
Overall trial start date
01/01/2012
Overall trial end date
01/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female patients aged 1845 years
2. Diagnosis of anorexia nervosa
3. BMI ≤18.5 kg/m² at time zero
4. BMI ≥ 18.5 kg/m² at the end of the treatment
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
55 female patients with a diagnosis of anorexia nervosa
Participant exclusion criteria
1. Participants that do not satisfy inclusion criteria.
2. Participants with active substance abuse, schizophrenia and other psychotic disorders
Recruitment start date
01/01/2012
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Italy
Trial participating centre
Monte Baldo Street, 89
Garda
37016
Italy
Sponsor information
Organisation
Villa Garda Hospital (Italy)
Sponsor details
Monte Baldo Street
89
Garda
Garda
Italy
+39 (0)456208611
info@villagarda.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Villa Garda Hospital (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list