Early Detection of Patients with Eating Disorders in General Practice

NCT06595381 | Not Yet Recruiting

• 1 other identifier: 0894/2023
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eating Disorder Prevention; Eating Disorders

Keywords

Eating Disorder; Anorexia Nervosa; Bulimia Nervosa; Binge Eating Disorder; general practice; prevention; early diagnosis

Outcome Measures

Primary Outcomes (1)

• Predictive capacity of the Eating Disorder Proxy Screening Tool for General Practitioners (ED-PSTGP) questionnaire in identifying patients with EDs

  3 years from the start of participant enrollment.

Secondary Outcomes (1)

• Efficacy of the ED-PSTGP questionnaire in General Practice as a tool for the early detection of individuals affected by EDs.

  3 years from the start of participant enrollment.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• Donini Lorenzo M: lead

Related Publications (13)

• Quaderni del Ministero della Salute n. 29, settembre 2017. Linee di indirizzo nazionali per la riabilitazione nutrizionale nei disturbi dell'alimentazione. www.quadernidellasalute.it.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Pinhas L, Morris A, Crosby RD, Katzman DK. Incidence and age-specific presentation of restrictive eating disorders in children: a Canadian Paediatric Surveillance Program study. Arch Pediatr Adolesc Med. 2011 Oct;165(10):895-9. doi: 10.1001/archpediatrics.2011.145.

  PMID: 21969390 BACKGROUND

• Lahteenmaki S, Saarni S, Suokas J, Saarni S, Perala J, Lonnqvist J, Suvisaari J. Prevalence and correlates of eating disorders among young adults in Finland. Nord J Psychiatry. 2014 Apr;68(3):196-203. doi: 10.3109/08039488.2013.797021. Epub 2013 Jun 10.

  PMID: 23750986 BACKGROUND

• Freund KM, Graham SM, Lesky LG, Moskowitz MA. Detection of bulimia in a primary care setting. J Gen Intern Med. 1993 May;8(5):236-42. doi: 10.1007/BF02600088.

  PMID: 8505681 BACKGROUND

• Broomfield C, Stedal K, Touyz S, Rhodes P. Labeling and defining severe and enduring anorexia nervosa: A systematic review and critical analysis. Int J Eat Disord. 2017 Jun;50(6):611-623. doi: 10.1002/eat.22715. Epub 2017 Apr 25. English, Spanish.

  PMID: 28444828 BACKGROUND

• Anstine D, Grinenko D. Rapid screening for disordered eating in college-aged females in the primary care setting. J Adolesc Health. 2000 May;26(5):338-42. doi: 10.1016/s1054-139x(99)00120-2.

  PMID: 10775826 BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Disease

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathologic Processes

Central Study Contacts

Lorenzo M Donini, MD

CONTACT

0649690215; lorenzomaria.donini@uniroma1.it

Study Design

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

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09