FamFINED: FAMily Factors INvolved in Eating Disorders

Sponsor

University Medical Center Goettingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05339165

Collaborator

(none)

600

Enrollment

Locations

85.9

Anticipated Duration (Months)

300

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational study compares parental age and birth order in patients diagnosed with anorexia nervosa and bulimia nervosa.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders	Behavioral: Psychotherapy

Detailed Description

Study participants are recruited (300 patients for each entity). Healthy subjects without evidence of an eating disorder serve as a control group. Psychometric assessment will include data on pathological eating behavior and general psychological and interpersonal problems.

Outcome measures The SCL-90-R questionnaire is a self-report inventory for adolescents and adults that assesses a wide range of psychological problems and symptoms of psychopathology. The questionnaire consists of 90 items, each of which contributes to one of nine primary symptom dimensions.

The short form of the Inventory of Interpersonal Problems (IIP-C) is used to measure interpersonal problems. This self-report questionnaire contains 64 items assigned to eight subscales.

Eligible candidates are stratified as cases or matched controls as follows:

Cases are eligible patients diagnosed with anorexia nervosa or bulimia nervosa (n=300 for each entity) at the time of study inclusion.
Controls (100) are healthy subjects of a similar age distribution and from the same study site without the diagnosis of an eating disorder.

Inclusion criteria:

Age > 12 and < 59 years (adolescents and adults).

Exclusion criteria:

Diagnosed with a malignant disease
Not fluent in the German language
Severe mental disorder

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

FAMily Factors INvolved in Eating Disorders

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Outcome Measures

Primary Outcome Measures

SCL-90-R questionnaire [One day]
The SCL-90-R questionnaire is a self-report inventory for adolescents and adults that assesses a wide range of psychological problems and symptoms of psychopathology. The questionnaire consists of 90 items, each of which contributes to one of nine primary symptom dimensions.
Short form of the Inventory of Interpersonal Problems (IIP-C) [One day]
The short form of the Inventory of Interpersonal Problems (IIP-C) is used to measure interpersonal problems. This self-report questionnaire contains 64 items assigned to eight subscales.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 59 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Age > 12 and < 59 years (adolescents and adults) with either anorexia nervosa or bulimia nervosa.

Exclusion Criteria:

Diagnosed with a malignant disease
Not fluent in the German language
Severe mental disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Göttingen	Göttingen	NDS	Germany	37073
2	University Medical Center	Göttingen		Germany	37073

Sponsors and Collaborators

University Medical Center Goettingen

Investigators

Principal Investigator: Thomas Meyer, University of Göttingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Thomas Meyer, Head of Laboratory, University Medical Center Goettingen

ClinicalTrials.gov Identifier:

NCT05339165

Other Study ID Numbers:

32/1/17

First Posted:

Apr 21, 2022

Last Update Posted:

Apr 21, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. Thomas Meyer, Head of Laboratory, University Medical Center Goettingen

Eating disorder, anorexia nervosa, bulimia nervosa

Additional relevant MeSH terms:

Disease

Feeding and Eating Disorders

Study Results

No Results Posted as of Apr 21, 2022