Body composition, eating disorder psychopathology and psychological distress in anorexia nervosa
| ISRCTN | ISRCTN92626057 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92626057 |
| Secondary identifying numbers | 01 |
- Submission date
- 08/12/2013
- Registration date
- 16/12/2013
- Last edited
- 23/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Monte Baldo Street, 89
Garda
37016
Italy
Study information
| Study design | Longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Body composition, eating disorder psychopathology and psychological distress in anorexia nervosa: a longitudinal study |
| Study objectives | 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(s) | Institutional Review Board of Villa Garda Hospital, 15/12/2010 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2011 |
| Completion date | 07/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 50 female patients with a diagnosis of anorexia nervosa, and 100 age and BMI matched healthy controls |
| Key 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 |
| Key exclusion criteria | 1. Participants that do not satisfy inclusion criteria 2. Participants with active substance abuse, schizophrenia and other psychotic disorders |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 07/01/2013 |
Locations
Countries of recruitment
- Italy
Study participating centre
37016
Italy
Sponsor information
Hospital/treatment centre
Monte Baldo Street, 89
Garda
37016
Italy
"ROR" |
https://ror.org/01mw6s018 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2014 | Yes | No |
