The relationship between body fat and long-term clinical outcome in anorexia nervosa

• Register: ISRCTN
• Last refreshed on: 8 June 2020
• Main ID: ISRCTN29929022
• Date of registration: 31/10/2014
• Prospective Registration: No
• Primary sponsor: Villa Garda Hospital (Italy)
• Public title: The relationship between body fat and long-term clinical outcome in anorexia nervosa
• Scientific title: The relationship between body fat and long-term clinical outcome in anorexia nervosa: a longitudinal study
• Date of first enrolment: 01/01/2012
• Target sample size: 55
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN29929022
• Study type: Observational
• Study design: Longitudinal study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Marwan El Ghoch

Key inclusion & exclusion criteria

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

Exclusion criteria:
1. Participants that do not satisfy inclusion criteria.
2. Participants with active substance abuse, schizophrenia and other psychotic disorders


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Anorexia nervosa/body composition
Mental and Behavioural Disorders

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Source(s) of Monetary Support

Villa Garda Hospital (Italy)

Ethics review

Status:
Approval date:
Contact:

Institutional Review Board of Villa Garda Hospital, 15/12/2011, ref. 03_2012

Results

• Results available: Yes
• Date Completed: 01/01/2015