Clinical trial NCT06595381: Early Detection of Patients with Eating Disorders in General Practice
Official title: Early Detection of Patients with Eating Disorders in General Practice
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Eating Disorder Prevention
Eating Disorders
Keywords: Eating Disorder
Anorexia Nervosa
Bulimia Nervosa
Binge Eating Disorder
general practice
prevention
early diagnosis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (aged ≥18 years) enrolled by General Practitioners (GPs) across Italy and their family members aged ≥16 years. Patients are selected from GP practices to complete the ED-PSTGP questionnaire, which aims to identify potential cases of eating disorders (EDs). Family members identified by these patients as potentially affected by an ED will also be included in the study. All participants must be able to provide informed consent for participation and for the anonymized use of their data.

Brief summary: The goal of this observational study is to assess the efficacy of the Eating Disorder Proxy Screening Tool for General Practitioner (ED-PSTGP) as a tool for the early detection of eating disorders (EDs) in General Practice (GP). The ED-PSTGP is a hetero-evaluative questionnaire that investigates the presence of suspected eating disorder symptoms among the family members of the person completing the questionnaire. The study will involve adult patients over 18 years old enrolled in a general practice and their family members aged 16 years or older.

The main questions it aims to answer are:

* Can the ED-PSTGP questionnaire effectively identify patients with potential eating disorders through responses from a family member?
* How effective is the ED-PSTGP questionnaire in general practice as an early detection tool for eating disorders?

Participants will:

* Be asked by their General Practitioner (GP) to complete the ED-PSTGP questionnaire.
* If a positive result is found, invite the potentially affected family member to complete additional screening questionnaires online.

The potentially affected family member will be offered a teleconsultation with specialists and encouraged to contact the nearest reference center for ED treatment to further investigate potential eating disorders.

Detailed description: Eating Disorders (EDs) represent a serious public health issue that, in recent years, has taken on the characteristics of a true social epidemic. Timely diagnosis and treatment play a crucial role in the resolution of the disorder and in the prevention of chronic complications. Unfortunately, many individuals seek care with significant delay, resulting in severe prognostic consequences and a high risk of chronicity. General Practitioners (GPs), as primary care providers in direct contact with the public, often represent the first point of contact between patients and the National Health System. The families of those affected by these disorders can play a crucial role in the diagnostic-therapeutic process by identifying the symptoms early, which may appear very subtle in the initial stages.

STUDY DESIGN Forty GPs, distributed across the national territory and selected by the Italian Society of Preventive Medicine and Lifestyle (SIMPeSV), will collaborate in the study. Enrollment will be non-competitive, and each participating GP will be required to administer the ED-PSTGP questionnaire to 30 adult patients.

The GP will be responsible for evaluating the test. The presence of a positive answer to any of the 13 items in the questionnaire will be considered sufficient to raise a suspicion of ED. Patients who complete a test evaluated as positive will be asked to provide the following questionnaires to the potentially affected family member:

* Eating Disorder Screen for Primary Care (ESP)
* Sick, Control, One stone, Fat, Food (SCOFF)
* Disordered Eating Questionnaire (DEQ)
* Beck Depression Inventory II (BDI II) The questionnaires and informed consent will be offered on an online platform and in Italian language.

The family members indicated as potentially affected by EDs will be offered a teleconsultation (with the operators from the Nutrition Science Research Unit of the University of Rome La Sapienza; and the Clinical Psychology and Counseling Service of the University of Rome La Sapienza) to further investigate the suspicion of eating disorder.

The GP will encourage individuals with suspected ED to contact the nearest reference center for ED treatment for diagnostic confirmation and possible management.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years, for patients enrolled by a General Practitioner (GP) to complete the ED-PSTGP questionnaire.
* Ability to provide informed consent for participation in the study.
* Age ≥ 16 years, for family members of GP patients, identified as pontentially affected by an eating disorder.

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Predictive capacity of the Eating Disorder Proxy Screening Tool for General Practitioners (ED-PSTGP) questionnaire in identifying patients with EDs
timeFrame: 3 years from the start of participant enrollment.
Secondary outcomes:
measure: Efficacy of the ED-PSTGP questionnaire in General Practice as a tool for the early detection of individuals affected by EDs.
timeFrame: 3 years from the start of participant enrollment.
Other outcomes:
Locations:
Study officials:
References:
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