Clinical trial NCT06514456: Italian Validation of the State Urge to be Physically Active- Questionnaire (SUPAQ-I) in Patients With Eating Disorders
Official title: Italian Validation of the State Urge to be Physically Active- Questionnaire (SUPAQ-I) in Patients With Eating Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Feeding and Eating Disorders
Keywords: Eating Disorders
State Urge to be Physically Active
Anorexia Nervosa
Bulimia Nervosa
Binge Eating Disorder
Questionnaire Language Validation
Urge to move
Physical activity
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 210
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Eating disorders (EDs) are characterized by a persistent disturbance of eating or eating-related behaviour resulting in altered consumption or absorption of food and leading to both life-threatening somatic complications and psychosocial impairment. Like most psychiatric disorders, EDs underlie pathogenetic mechanisms implying the interaction of neurobiological and genetic factors with the environment. EDs cause over 3000 deaths per year with worsening illness course and increasing chronic cases. For people suffering from EDs, quality of life is reduced and yearly healthcare costs are 48% higher than in the general population. Specifically, Anorexia Nervosa and Bulimia Nervosa report the highest mortality rates among EDs and psychiatric disorders in general. Following the outbreak of Covid-19 pandemic, a concerning increase in both hospital admissions rates and outpatient visits was reported worldwide especially in paediatric populations. Along with this surge in ED cases, changes in symptoms manifestation were also reported, especially in terms of increase in restrictive eating, social media use, comorbid anxiety and depression symptoms and compulsive physical exercise. Food obsession, concerns about body shape and weight contribute to favour ED patients engagement in ritualised behaviours such as counting calories, frequent weighing and problematic physical activity (PA), in terms of frequency, duration and intensity. Notably, up to 80% of individuals with AN engage in voluntary compulsive exercise as a form of weight control. Simultaneously, on a neurobiological basis, starvation appear to heightened the urge to move and restlessness in AN. Current interventions for AN primarily focus on addressing various facets of eating disorders, but treatments exhibit limited efficacy in targeting physical exercise, despite the growing recognition of PA as a pivotal factor reinforcing eating pathology. The heightened restlessness activation in AN might also contribute to the overestimation of body size by enhancing proprioception. Thus far, there are just a few validated instruments to assess acute activity urges in ED patients, with the State Urge to be Physically Active Questionnaire (SUPA-Q), being the only one validated in this clinical population and covering several of the cognitive, emotional and specific behavioural aspects related to activity urges. The SUPA-Q, a 21-item self-report questionnaire, has demonstrated high consistency, reliability, as well as convergent, divergent and factorial validity. Sensitivity to change has also been tested (Cohen's d= 0.48). However, to the best of our knowledge, there has been only one validation study of the SUPA-Q. The objective of this study is to evaluate the psychometric properties of the Italian version of the SUPA-Q, and to test its validity in a clinical sample of patients with EDs.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Height
timeFrame: through study completion, an average of 24 months
measure: Weight
timeFrame: through study completion, an average of 24 months
measure: BMI
timeFrame: through study completion, an average of 24 months
measure: State Urge to be Physically Active Questionnaire Italian Version (SUPAQ-I)
timeFrame: through study completion, an average of 24 months
Secondary outcomes:
measure: Eating Disorder Inventory-3 (EDI-3)
timeFrame: through study completion, an average of 24 months
measure: Compulsive Exercise Test (CET)
timeFrame: through study completion, an average of 24 months
measure: Exercise Addiction Inventory - Revised (EAI-R)
timeFrame: through study completion, an average of 24 months
measure: Barratt Impulsiveness Scale (15 item) (BIS-15)
timeFrame: through study completion, an average of 24 months
Other outcomes:
measure: Age
timeFrame: through study completion, an average of 24 months
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
affiliation: IRCCS Istituto Auxologico Italiano
name: Leonardo Mendolicchio, M.D.
role: PRINCIPAL_INVESTIGATOR
References: