Eating Disorder PreventionNCT06595381
Early Detection of Patients with Eating Disorders in General Practice
An observational study of Eating Disorder Prevention and Eating Disorders, run by Donini Lorenzo M.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Disorder Prevention, Eating Disorders
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Eating Disorder Prevention, Eating Disorders
- Keywords
- Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, general practice, prevention, early diagnosis
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive capacity of the Eating Disorder Proxy Screening Tool for General Practitioners (ED-PSTGP) questionnaire in identifying patients with EDs
Measured: 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.
Measured: 3 years from the start of participant enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Eating Disorder PreventionStudies of the same condition, open and under way.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donini Lorenzo M
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Donini Lorenzo M, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595381
- Sponsor's protocol ID
- 0894/2023
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 12153817Qian 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.
PubMed 33834377Morgan 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.
PubMed 10582927McNulty PA. Prevalence and contributing factors of eating disorder behaviors in active duty Navy men. Mil Med. 1997 Nov;162(11):753-8.
PubMed 9358723Luck 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.
PubMed 12364305Lombardo 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.
PubMed 15330075Lombardo 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.
PubMed 22290035Pinhas 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.
PubMed 21969390Lahteenmaki 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.
PubMed 23750986Freund 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.
PubMed 8505681Broomfield 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.
PubMed 28444828Anstine 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.
PubMed 10775826
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Patients with Eating Disorders in General Practice
- ClinicalTrials.gov ID
- NCT06595381
- Acronym / sponsor ID
- 0894/2023
- Conditions
- Eating Disorder Prevention, Eating Disorders
- Keywords
- Eating Disorder, Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, general practice, prevention, early diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Donini Lorenzo MUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 19 Sep 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- BackgroundQuaderni del Ministero della Salute n. 29, settembre 2017. Linee di indirizzo nazionali per la riabilitazione nutrizionale nei disturbi dell'alimentazione. www.quadernidellasalute.it.
- Background: PubMed 12153817Steinhausen 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.
- Background: PubMed 33834377Qian 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.
- Background: PubMed 10582927Morgan 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.
- Background: PubMed 9358723McNulty PA. Prevalence and contributing factors of eating disorder behaviors in active duty Navy men. Mil Med. 1997 Nov;162(11):753-8.
- Background: PubMed 12364305Luck 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.
- Background: PubMed 15330075Lombardo 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.
- Background: PubMed 22290035Lombardo 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.
- Background: PubMed 21969390Pinhas 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.
- Background: PubMed 23750986Lahteenmaki 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.
- Background: PubMed 8505681Freund 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.
- Background: PubMed 28444828Broomfield 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorder Prevention and Eating Disorders, run by Donini Lorenzo M.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo M Donini, MD (0649690215, lorenzomaria.donini@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT06595381, which also lists 13 linked publications.
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 19 Sep 2024.