Condition category
Mental and Behavioural Disorders
Date applied
08/12/2013
Date assigned
16/12/2013
Last edited
23/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Anorexia nervosa (AN) is characterized by weight loss and reduction of body mass (lean and fat masses). Weight restoration is a key procedure in the treatment of these patients. However, for a normal resumption of physiological processes it is necessary to restore an adequate amount and distribution of body mass (lean and fat). Furthermore, no study has assessed the influence of body composition changes on eating disorder psychopathology and psychological distress in AN patients. The aim of this study is to assess body composition and fat mass distribution before and after body weight restoration and to investigate the relationship between body fat pattern changes and eating disorder and psychological distress in AN patients treated in a specialist inpatient unit.

Who can participate?
We recruited 50 female patients with a diagnosis of anorexia nervosa, and 100 age and body mass index (BMI) matched healthy controls.

What does the study involve?
All patients with AN received the same treatment: cognitive behavioural therapy (CBT-E) (psychological treatment) and weight restoration. Tests were done to measure body composition and assess eating disorder psychopathology and psychological distress in all patients.

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 recruitment started in January 2011 and ended in January 2013.

Who is the funding the study?
Villa Garda Hospital (Italy)

Who is the main contact?
Dr Marwan El Ghoch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marwan El Ghoch

ORCID ID

Contact details

Monte Baldo Street
89
Garda
37016
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01

Study information

Scientific title

Body composition, eating disorder psychopathology and psychological distress in anorexia nervosa: a longitudinal study

Acronym

Study hypothesis

Anorexia nervosa (AN) patients have different body composition with respect to healthy controls after immediate weight normalization. This difference in body composition may negatively influence treatment outcome and may have some psychological effects.

Ethics approval

Institutional Review Board of Villa Garda Hospital, 15/12/2010

Study design

Longitudinal study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anorexia nervosa/body composition

Intervention

We recruited 50 female patients with a diagnosis of anorexia nervosa and 100 age and BMI matched healthy controls for an observational study. The interventions are weight restoration and cognitive behavioural therapy (psychological treatment). All patients received the same treatment.

Body composition was measured using dual-energy X-ray absorptiometry (DXA) in anorexia nervosa patients and in healthy controls. The Eating Disorder Examination interview (EDE) and the Brief Symptom Inventory (BSI) were used to assess eating disorder psychopathology and psychological distress, respectively.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. To assess the change in lean and fat masses and their distribution (using DXA) before and after complete weight restoration in AN patients.
2. To compare body composition and fat distribution (using DXA) of weight-restored AN patients with a healthy age- and post-treatment BMI-matched control group.

All outcomes were collected at baseline and at the end of the treatment (20 weeks of treatment).

Secondary outcome measures

To assess the relationship between body composition patterns (using DXA), eating disorder psychopathology (using EDE) and general distress (using BSI) in AN patients. All outcomes were collected at baseline and at the end of the treatment (20 weeks of treatment).

Overall trial start date

01/01/2011

Overall trial end date

07/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients aged 18–50 years
2. Diagnosis of anorexia nervosa
3. Body mass index (BMI) ≤17.5 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

50 female patients with a diagnosis of anorexia nervosa, and 100 age and BMI matched healthy controls

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

01/01/2011

Recruitment end date

07/01/2013

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
37016
Italy

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24500157

Publication citations

  1. Results

    El Ghoch M, Milanese C, Calugi S, Pellegrini M, Battistini NC, Dalle Grave R, Body composition, eating disorder psychopathology, and psychological distress in anorexia nervosa: a longitudinal study., Am. J. Clin. Nutr., 2014, 99, 4, 771-778, doi: 10.3945/ajcn.113.078816.

Additional files

Editorial Notes