跳至主要内容
临床试验/NCT06514456
NCT06514456招募中不适用

Italian Validation of the State Urge to be Physically Active- Questionnaire (SUPAQ-I) in Patients With Eating Disorders

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
210
试验地点
1
主要终点
Height

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Height

时间窗: through study completion, an average of 24 months

height in mt

BMI

时间窗: through study completion, an average of 24 months

body mass index (in kg/m2)

Weight

时间窗: through study completion, an average of 24 months

Weight in kg

State Urge to be Physically Active Questionnaire Italian Version (SUPAQ-I)

时间窗: through study completion, an average of 24 months

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.

次要结局

  • Eating Disorder Inventory-3 (EDI-3)(through study completion, an average of 24 months)
  • Compulsive Exercise Test (CET)(through study completion, an average of 24 months)
  • Exercise Addiction Inventory - Revised (EAI-R)(through study completion, an average of 24 months)
  • Barratt Impulsiveness Scale (15 item) (BIS-15)(through study completion, an average of 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验