Menu
Not yet recruiting NCT06595381

Early Detection of Patients with Eating Disorders in General Practice

Observational Eating Disorder Prevention Eating Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Eating Disorder Prevention, Eating Disorders. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Predictive capacity of the Eating Disorder Proxy Screening Tool for General Practitioners (ED-PSTGP) questionnaire in identifying patients with EDs [Time frame: 3 years from the start of participant enrollment.]
Secondary outcome measures (1)
  • Efficacy of the ED-PSTGP questionnaire in General Practice as a tool for the early detection of individuals affected by EDs. [Time frame: 3 years from the start of participant enrollment.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Quaderni del Ministero della Salute n. 29, settembre 2017. Linee di indirizzo nazionali per la riabilitazione nutrizionale nei disturbi dell'alimentazione. www.quadernidellasalute.it.
  • Steinhausen HC. The outcome of anorexia nervosa in the 20th century. Am J Psychiatry. 2002 Aug;159(8):1284-93. doi: 10.1176/appi.ajp.159.8.1284. PMID 12153817
  • Qian J, Wu Y, Liu F, Zhu Y, Jin H, Zhang H, Wan Y, Li C, Yu D. An update on the prevalence of eating disorders in the general population: a systematic review and meta-analysis. Eat Weight Disord. 2022 Mar;27(2):415-428. doi: 10.1007/s40519-021-01162-z. Epub 2021 Apr 8. PMID 33834377
  • Morgan JF, Reid F, Lacey JH. The SCOFF questionnaire: assessment of a new screening tool for eating disorders. BMJ. 1999 Dec 4;319(7223):1467-8. doi: 10.1136/bmj.319.7223.1467. No abstract available. PMID 10582927
  • McNulty PA. Prevalence and contributing factors of eating disorder behaviors in active duty Navy men. Mil Med. 1997 Nov;162(11):753-8. PMID 9358723
  • Luck AJ, Morgan JF, Reid F, O'Brien A, Brunton J, Price C, Perry L, Lacey JH. The SCOFF questionnaire and clinical interview for eating disorders in general practice: comparative study. BMJ. 2002 Oct 5;325(7367):755-6. doi: 10.1136/bmj.325.7367.755. No abstract available. PMID 12364305
  • Lombardo C, Russo PM, Lucidi F, Iani L, Violani C. Internal consistency, convergent validity and reliability of a brief questionnaire on disordered eating (DEQ). Eat Weight Disord. 2004 Jun;9(2):91-8. doi: 10.1007/BF03325051. PMID 15330075
  • Lombardo C, Cuzzolaro M, Vetrone G, Mallia L, Violani C. Concurrent validity of the Disordered Eating Questionnaire (DEQ) with the Eating Disorder Examination (EDE) clinical interview in clinical and non clinical samples. Eat Weight Disord. 2011 Sep;16(3):e188-98. doi: 10.1007/BF03325131. PMID 22290035

Identifiers

NCT: NCT06595381 · 0894/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗