Viewing Study NCT06514456



Ignite Creation Date: 2024-10-26 @ 3:35 PM
Last Modification Date: 2024-10-26 @ 3:35 PM
Study NCT ID: NCT06514456
Status: RECRUITING
Last Update Posted: None
First Post: 2024-05-30

Brief Title: Italian Validation of the State Urge to be Physically Active- Questionnaire SUPAQ-I in Patients With Eating Disorders
Sponsor: None
Organization: None

Study Overview

Official Title: Italian Validation of the State Urge to be Physically Active- Questionnaire SUPAQ-I in Patients With Eating Disorders
Status: RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SUPAQ-I
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-Is 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 Cronbachs α and McDonalds 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 Cohens d 048 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None