Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Adolescents are especially vulnerable to develop eating disorders. School prevention programs have been found to be effective at reducing the occurrence of eating disorders. However, existing prevention programs were mainly focused on female participants. Their transference in the everyday life at school was therefore difficult. The aim of this study is to develop a time-effective eating disorder prevention program which addresses young females and males.

Who can participate?
School-attending adolescents in the 8th or 11th grade (age 14 and 17)

What does the study involve?
Students are randomly allocated to either a control group or an intervention group. The intervention comprises three 90-minute units which are delivered over a two-week period. The first unit occurs on its own while the second and third units occur straight after each other one week later. The prevention program comprises interactive and educational elements about eating disorders and their treatment. Participants pass through different exercises and reflect on the influences of the media, self-esteem, body perception and individual resources. Eating disorder risk, internalization of Western beauty ideals, body dissatisfaction, self-concept as well as anxiety and symptoms of depression are measured before and immediately after the intervention as well as at a six-month follow-up using self-report measures. Participants in the intervention group complete a questionnaire at baseline, at the end of the intervention and at six months after the intervention. Participants in the control group complete the questionnaire at equal intervals without receiving any intervention.

What are the possible benefits and risks of participating?
Participants might decrease their individual eating disorder risk after participation in the prevention program through improvements in coping with negative emotions and pressure from media, peers and family. They might also strengthen their individual resources like social support or the activation of existing functional coping strategies. All participants receive a flyer compromising information and treatment options for adolescents suffering from eating disorders. If students themselves or a friend suffers from an eating disorder or teachers have an eating disorder suspicion in their classes the Principal Investigator is contactable to answer any questions. Such incidents are recorded and monitored throughout the study.

Where is the study run from?
University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine and Psychotherapy (Germany)

When is the study starting and how long is it expected to run for?
February 2012 to July 2014

Who is funding the study?
Federal Ministry of Education and Research (Germany)

Who is the main contact?
Prof. Bernd Löwe

Trial website

Contact information



Primary contact

Prof Bernd Löwe


Contact details

Universitätsklinikum Hamburg-Eppendorf
Institut für Psychosomatische Medizin und Psychotherapie
Martinistr. 52

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The "Healthcare Network Anorexia and Bulimia Nervosa"-campaign - Focal-project 1: Prevention trail at 20 secondary schools in Hamburg: a cluster-randomized controlled trial


Study hypothesis

Primary hypothesis: The application of the school-based primary preventive campaign to a high risk student sample leads to a reduction of individual's risk factors for eating disorders in adolescence and gain of knowledge on the subject of eating disorders

Secondary hypothesis: The application of the school-based primary preventive campaign to a high risk student sample leads to an improvement of the body-related self-worth as well decrease in depressiveness and a reduction of the internalization of the ideal of slimness.

Ethics approval

Ethics Committee of the Psychotherapist Chamber of the Free and Hanseatic City of Hamburg, 26/07/2011

Study design

Cluster-randomized controlled trial with repeated measurements

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact information to request a patient information sheet


Anorexia nervosa, bulimia nervosa


The prevention campaign which will be administered to the experimental group will consist of 3 teaching units of 90 minutes respectively. The first lesson unit will serve to assess the students current state of knowledge in the subject of eating and eating disorders. The preventive workshop will be given in the second teaching unit and consist of interactive exercises to attain knowledge about eating disorders, role plays, audiotexts focusing on certain aspects of the subject and an internet-self-test. The last lesson will conclude the module with an encounter with patients and a final debriefing.

The control group will be given the choice to participate in the workshop program after the trial will be concluded (in terms of a waiting list control condition) or to take part in a career exploration day offered by the research institute.

Intervention type



Drug names

Primary outcome measure

1. Risk status for the development of an eating disorder assessed by child version of the Eating Disorder Examination (ChEDE-Q)
2. Knowledge on the subject of eating disorders (Knowledge test)

Measured thrice for each participant in terms of a repeated measure design, 1 month before the intervention, immediately after the intervention and 6 months after the intervention.

Secondary outcome measures

1. Societal influences on body image and eating disturbances, measured using Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ-G)
2. Self-worth, measured using MSWS
3. Depressiveness, measured using Patient Health Questionnaire (PHQ-9)
4. Anxiety, measured using Generalised Anxiety Disorder Assessment (GAD-7)
5. Health outcome, measured using EQ-5D

Measured thrice for each participant in terms of a repeated measure design, 1 month before the intervention, immediately after the intervention and 6 months after the intervention.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Informed consent
2. Enrolment in grades 8 or 11

Participant type


Age group




Target number of participants

To be screened: 2340 , to be recruited: 2.240, to be evaluated: 1.792

Participant exclusion criteria

Deficiencies in the command of the German language

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University Medical Centre Hamburg-Eppendorf (Universitätsklinikum Hamburg-Eppendorf)
Department of Psychosomatic Medicine and Psychotherapy Martinistrasse 52

Sponsor information


Federal Ministry of Education and Research (Germany)

Sponsor details

Bundesministerium für Bildung und Forschung - BMBF
Dienstsitz Berlin
Hannoversche Straße 28-30

Sponsor type




Funder type


Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

National government



Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Basic results (scientific)

Publication list

2015 protocol in:
2017 results in:

Publication citations

Additional files

Editorial Notes

15/08/2017: Publication reference added. 11/12/2014: The following changes were made to the trial record: 1. The overall start date was changed from 01/02/2012 to 01/04/2011. 2. The overall end date was changed from 31/07/2014 to 31/12/2015.