The relationship between body fat and long-term clinical outcome in anorexia nervosa
| ISRCTN | ISRCTN29929022 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29929022 |
| Secondary identifying numbers | 03 |
- Submission date
- 19/10/2014
- Registration date
- 31/10/2014
- Last edited
- 29/05/2020
- 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 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
Contact information
Scientific
Monte Baldo Street, 89
Garda
37016
Italy
| Phone | +39 (0)456208611 |
|---|---|
| marwan1979@hotmail.com |
Study information
| Study design | Longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.villagarda.it/Libretto%20DA.pdf (in Italian only) |
| Scientific title | The relationship between body fat and long-term clinical outcome in anorexia nervosa: a longitudinal study |
| Study objectives | 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(s) | Institutional Review Board of Villa Garda Hospital, 15/12/2011, ref. 03_2012 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2012 |
| Completion date | 01/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 55 female patients with a diagnosis of anorexia nervosa |
| Key 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 |
| 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 | 01/01/2012 |
| Date of final enrolment | 01/01/2015 |
Locations
Countries of recruitment
- Italy
Study participating centre
37016
Italy
Sponsor information
Hospital/treatment centre
Monte Baldo Street, 89
Garda
Garda
Italy
| Phone | +39 (0)456208611 |
|---|---|
| info@villagarda.it | |
| Website | http://www.villagarda.it/index_eng.html |
"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 |
Editorial Notes
29/05/2020: No publications found.
