Condition category
Mental and Behavioural Disorders
Date applied
19/10/2014
Date assigned
31/10/2014
Last edited
31/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

Eligibility

Participant inclusion criteria

1. Female patients aged 18–45 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

http://www.villagarda.it/index_eng.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes