About this trial
Eating disorders (EDs) are severe psychiatric conditions that cause significant health and psychosocial issues, with Anorexia Nervosa (AN) and Bulimia Nervosa (BN) having the highest mortality rates. The COVID-19 pandemic has led to an increase in ED cases, especially among children, with heightened restrictive eating and compulsive exercise. Up to 80% of individuals with AN engage in compulsive exercise, which current treatments fail to adequately address.
The State Urge to be Physically Active Questionnaire (SUPA-Q) is the only validated tool for assessing activity urges in ED patients, covering cognitive, emotional, and behavioral aspects. This study aims to develop and validate an Italian version of the SUPA-Q (SUPAQ-I) in a clinical sample of ED patients.
A mixed-longitudinal study design will be used, with assessments at admission (T0) and discharge (T1) to evaluate the SUPAQ-I's reliability, validity, and sensitivity to change. The sample will include patients aged 16-65 diagnosed with EDs undergoing inpatient rehabilitation. Statistical analyses will include exploratory and confirmatory factor analyses, and internal consistency will be measured using Cronbach's α and McDonald's Ω indices.
Validating the SUPAQ-I will improve the assessment of activity urges in ED patients, enhancing treatment strategies and outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 16 and 65 years old;
diagnosis of ED as per DSM 5 or DSM-5 TR
BMI* range between 13 and 30 kg/m2 (depending on ED main diagnosis)
for the pediatric population BMI SDS** range is set between -3 and +3 SD from expected BMI for age and sex
Disqualifiers
presence of other pathologies not associated with ED (i.e., neurodegenerative diseases);
severe psychopathologies other than ED (i.e., schizophrenia)
BMI will be calculated using the following formula: weight (kg)/height (m2) **For the pediatric population, BMI SDS will also be calculated to adjust BMI according to growth curve charts for children and adolescents belonging to the Italian population
Trial population
Individuals of both biological sexes affected by ED who will take part in the multidisciplinary inpatient intensive rehabilitation treatment as offered by the U.O. dei Disturbi del Comportamento Alimentare, San Giuseppe Hospital, Piancavallo (VCO), Italy.
Trial design
Cohort
Prospective
Treatments tested in this trial
no intervention
Other interventionno intervention
Treatment groups
Trial outcomes
Primary outcomes
Height
height in mt
Weight
Weight in kg
BMI
body mass index (in kg/m2)
State Urge to be Physically Active Questionnaire Italian Version (SUPAQ-I)
State Urge to be Physically Active Questionnaire Italian Version (SUPAQ-I): It consists of a 21-item self-report questionnaire on a 5-point Likert scale (not at all, very little somewhat, quite a bit, a great deal). Items are divided into four scales (burden, emotional aspects, cognitive aspects and motor aspects). The higher the score, the greater the restlessness and the "state" urge to be physically active. Min. score: 0; max. score: 84. A decrease in SUPAQ-I scores means a better outcome.
Secondary outcomes
Eating Disorder Inventory-3 (EDI-3)
The questionnaire consists of 91 items evaluated on a six-point Likert scale (always, usually, often, sometimes, rarely, never). The 91 items are divided into twelve primary scales (three scales three refer specifically to the eating disorder: drive for thinness (min 7, max 42), bulimia (min 8, max 48), and body dissatisfaction (min 10, max 60); nine general psychological scales relevant but non-specific for eating disorders: low self-esteem (min 6, max 36), personal alienation (min 7, max 42), interpersonal insecurity (min 7, max 42), interpersonal alienation (min 7, max 42), interoceptive deficits (min 9, max 54), emotional dysregulation (min 8, max 48), perfectionism (min 6, max 36), asceticism (min 7, max 42), and maturity fears (min 8, max 48). The higher the score, the greater the severity of the symptoms. A decrease in EDI-3 scores means a better outcome.
Compulsive Exercise Test (CET)
The CET consists of a 24-item self-administered questionnaire evaluated on a 6-point Likert scale from 0 (never true) to 5 (always true). Items are divided into four scales (avoidance, weight control, mood, lack of enjoyment and rigidity). The Italian version of the CET showed acceptable reliability (Cronbach's α coefficients for all the domains \> .70). The higher the score, the greater the "trait"-like compulsive physical activity (cut-off is set at 15 points). Min score: 0; max. score: 120. A decrease in CET scores means a better outcome.
Exercise Addiction Inventory - Revised (EAI-R)
Exercise Addiction Inventory - Revised : The EAI-R consists of a 6-item self-report questionnaire evaluated on a 6-point Likert scale from 1 (strongly disagree) to 6 (strongly agree). The higher the score the strongest the exercise addiction risk. Min score: 6; max score: 36. A decrease in EAI-R scores means a better outcome.
Barratt Impulsiveness Scale (15 item) (BIS-15)
Barratt Impulsiveness Scale (15 item): It consists of a 15-item self-report questionnaire evaluated on a 4-point Likert scale from 1 (rarely/never) to 4 (almost always/always). Items are divided into four scales (pure impulsivity, planning and thinking, lack of attention and concentration impulsive buying). The higher the total score, the greater impulsivity. Min score: 15; max score: 60. This questionnaire will be used to test for divergent validity of the SUPAQ-I.
Other outcomes
Age
age in years
Sponsors and contacts
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