Feeding and Eating DisordersSUPAQ-INCT06514456
Italian Validation of the State Urge to be Physically Active- Questionnaire (SUPAQ-I) in Patients With Eating Disorders
An observational study of Feeding and Eating Disorders, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Feeding and Eating Disorders
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 7 May 2024to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan
Leonardo Mendolicchio, M.D.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Feeding and Eating Disorders
- Being tested
- no intervention
- Keywords
- Eating Disorders, State Urge to be Physically Active, Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Questionnaire Language Validation, Urge to move, Physical activity
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
height in mt
Measured: through study completion, an average of 24 months
Weight
Weight in kg
Measured: through study completion, an average of 24 months
BMI
body mass index (in kg/m2)
Measured: 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.
Measured: through study completion, an average of 24 months
Secondary outcomes (4)
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.
Measured: through study completion, an average of 24 months
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.
Measured: through study completion, an average of 24 months
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.
Measured: through study completion, an average of 24 months
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.
Measured: through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start7 May 2024
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonardo Mendolicchio, M.D., Principal investigator, IRCCS Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514456
- Sponsor's protocol ID
- 49C402
- Acronym
- SUPAQ-I
- Status last verified
- Jul 2024
- First submitted
- 30 May 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boltri M, Gabutti C, Brusa F, Cera G, Villa V, Bastoni I, Ducale S, Manzo F, Scalia A, Apicella E, Savino S, Castelnuovo G, Mendolicchio L. Psychometric validation of the Italian State Urge to Be Physically Active Questionnaire in eating disorders: Psychopathology correlates and diagnostic differences. Psychol Assess. 2026 Jul 23. doi: 10.1037/pas0001495. Online ahead of print.
PubMed 42490250
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Validation of the State Urge to be Physically Active- Questionnaire (SUPAQ-I) in Patients With Eating Disorders
- ClinicalTrials.gov ID
- NCT06514456
- Acronym / sponsor ID
- SUPAQ-I / 49C402
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- presence of other pathologies not associated with ED (i.e., neurodegenerative diseases);
- severe psychopathologies other than ED (i.e., schizophrenia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Height
Time frame: through study completion, an average of 24 months
height in mt
Weight
Time frame: through study completion, an average of 24 months
Weight in kg
BMI
Time frame: through study completion, an average of 24 months
body mass index (in kg/m2)
State Urge to be Physically Active Questionnaire Italian Version (SUPAQ-I)
Time frame: 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.
4 secondary outcomes
Eating Disorder Inventory-3 (EDI-3)
Time frame: through study completion, an average of 24 months
Compulsive Exercise Test (CET)
Time frame: through study completion, an average of 24 months
Exercise Addiction Inventory - Revised (EAI-R)
Time frame: through study completion, an average of 24 months
Barratt Impulsiveness Scale (15 item) (BIS-15)
Time frame: through study completion, an average of 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Derived from this study: PubMed 42490250Boltri M, Gabutti C, Brusa F, Cera G, Villa V, Bastoni I, Ducale S, Manzo F, Scalia A, Apicella E, Savino S, Castelnuovo G, Mendolicchio L. Psychometric validation of the Italian State Urge to Be Physically Active Questionnaire in eating disorders: Psychopathology correlates and diagnostic differences. Psychol Assess. 2026 Jul 23. doi: 10.1037/pas0001495. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo Mendolicchio, M.D. principal investigator
IRCCS Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding and Eating Disorders, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margherita Boltri, MSc (+393405242239, m.boltri@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: through study completion, an average of 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.