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

NCT06514456 | Recruiting

• 1 other identifier: 49C402
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Height

  height in mt

  through study completion, an average of 24 months

• Weight

  Weight in kg

  through study completion, an average of 24 months

• BMI

  body mass index (in kg/m2)

  through study completion, an average of 24 months

• 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.

  through study completion, an average of 24 months

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Age

  through study completion, an average of 24 months

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Officials

• Leonardo Mendolicchio, M.D.

  IRCCS Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margherita Boltri, MSc

CONTACT

+393405242239; m.boltri@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: July 23, 2024
• Study Start: May 7, 2024
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

IT (1)