Condition category
Mental and Behavioural Disorders
Date applied
04/10/2011
Date assigned
12/01/2012
Last edited
29/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 the present study was 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 years), who provide written informed consent. Participants under the age of 16 years need to provide additional informed consent from their parents.

What does the study involve?
Students are randomly assigned 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 status 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 will be 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?
Recruitment will be started in February 2012 and will be finished in July 2014.

Who is funding the study?
This study is funded by the Federal Ministry of Education and Research (Germany).

Who is the main contact?
Prof Bernd Löwe
b.loewe@uke.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bernd Löwe

ORCID ID

Contact details

Universitätsklinikum Hamburg-Eppendorf
Institut für Psychosomatische Medizin und Psychotherapie
Martinistr. 52
Hamburg
D-20246
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

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

Acronym

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.

On 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.

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

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

Anorexia nervosa, Bulimia nervosa

Intervention

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

Behavioural

Phase

Drug names

Primary outcome measures

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, one 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 [Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ-G)]
2. Self-worth (MSWS)
3. Depressiveness [Patient Health Questionnaire (PHQ-9)]
4. Anxiety [Generalised Anxiety Disorder Assessment (GAD-7)]
5. Health outcome (EQ-5D)

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

Overall trial start date

01/04/2011

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Child

Gender

Both

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

01/02/2012

Recruitment end date

31/07/2014

Locations

Countries of recruitment

Germany

Trial participating centre

University Medical Centre Hamburg-Eppendorf (Universitätsklinikum Hamburg-Eppendorf)
Department of Psychosomatic Medicine and Psychotherapy Martinistrasse 52
Hamburg
20246
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (Germany)

Sponsor details

Bundesministerium für Bildung und Forschung - BMBF
Dienstsitz Berlin
Hannoversche Straße 28-30
Berlin
D-10115
Germany

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

German Federal Ministry of Education and Research (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25884195

Publication citations

Additional files

Editorial Notes