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
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 measure
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 (if study stopped)
Eligibility
Participant inclusion criteria
1. Female patients aged 1850 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
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24500157
Publication citations
-
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.