The "Healthcare Network Anorexia and Bulimia nervosa"-campaign - Focal-project 1: Prevention trial at 20 secondary schools in Hamburg
| ISRCTN | ISRCTN97989348 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97989348 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/10/2011
- Registration date
- 12/01/2012
- Last edited
- 15/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
b.loewe@uke.de
Contact information
Scientific
Universitätsklinikum Hamburg-Eppendorf
Institut für Psychosomatische Medizin und Psychotherapie
Martinistr. 52
Hamburg
D-20246
Germany
Study information
| Study design | Cluster-randomized controlled trial with repeated measurements |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact information to request a patient information sheet |
| 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(s) | Ethics Committee of the Psychotherapist Chamber of the Free and Hanseatic City of Hamburg, 26/07/2011 |
| 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 |
| 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 study start date | 01/04/2011 |
| Overall study end date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | To be screened: 2340 , to be recruited: 2.240, to be evaluated: 1.792 |
| Participant inclusion criteria | 1. Informed consent 2. Enrolment in grades 8 or 11 |
| 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
Study participating centre
Martinistrasse 52
Hamburg
20246
Germany
Sponsor information
Government
Bundesministerium für Bildung und Forschung - BMBF
Dienstsitz Berlin
Hannoversche Straße 28-30
Berlin
D-10115
Germany
"ROR" |
https://ror.org/04pz7b180 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/02/2015 | Yes | No | |
| Results article | results | 11/08/2017 | Yes | No |
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.
