Condition category
Mental and Behavioural Disorders
Date applied
30/06/2007
Date assigned
05/11/2007
Last edited
17/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.psych.uni-potsdam.de/counseling/research/sozio-faktoren.html

Contact information

Type

Scientific

Primary contact

Prof Petra Warschburger

ORCID ID

Contact details

Karl-Liebknecht-Strasse 24-25
Potsdam
14476
Germany
+49 (0)331 9772874
warschb@uni-potsdam.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Förderkennzeichen 01EL0408

Study information

Scientific title

Acronym

POPS (Potsdamer prävention an schulen)

Study hypothesis

The participants of the prevention program show less symptoms of disordered eating and related risk factors 3 and 12 months after the program (compared to the control group).

Ethics approval

Ethics approval received from the ethics committee of the University of Potsdam on the 11th December 2006 (ref: 3/22).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

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

Condition

Eating disorders

Intervention

The participants who are randomised to the intervention group will receive the prevention program. Trained teachers will carry out 9 sessions of regular classes, 1 - 2 sessions a week, 45 minutes each. During the classes they will teach the participants about nutrition and well-being, media competency, self-esteem, problem solving, stress management, and dealing with appearance-related social pressure. Materials and methods include DVDs, games, discussions, quizzes, leaflets, questionnaires, homework and teamwork.

The participants allocated to the control group do not receive any intervention. They will receive the same training on the program after the evaluation of the program based on this trial is completed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Symptoms of eating disorders, measured at 3 and 12 months after completion of the program using the following:
1. Eating Attitudes Test (EAT)
2. Eating Disorder Inventory (EDI)
3. Eating Disorder Examination (EDE)

Secondary outcome measures

Current secondary outcome measures as of 16/10/2008:
Risk and protective factors assessed at 3 and 12 months after completion of the programme using the following:
1. Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ)
2. Appearance Schema Inventory (ASI)
3. Coping
4. Body dissatisfaction, assessed by the Contour Drawing Rating Scale (CDRS) and the Eating Disorder Inventory - Body Dissatisfaction (EDI-BD)
5. Appearance related social pressure questionnaire (Fragebogen zum aussehensbezogenen sozialen
Druck [FASD])

Please note that the changes are due to errors in the information submitted at time of registration.

Secondary outcome measures provided at time of registration:
Risk and protective factors assessed at 3 and 12 months after completion of the programme using the following:
1. Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ)
2. Appearance Schema Inventory (ASI)
3. Coping
4. Body dissatisfaction

Overall trial start date

01/07/2006

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Adolescents Grade 7 - 9 (12 - 16 years).

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1,200

Participant exclusion criteria

Does not comply with above criteria.

Recruitment start date

01/07/2006

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Karl-Liebknecht-Strasse 24-25
Potsdam
14476
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (BMBF) (Germany)

Sponsor details

German Aerospace Center (DLR)
Heinrich-Konen-Strasse 1
Bonn
53227
Germany
+49 (0)228 3821149
daniela.hofmann@dlr.de

Sponsor type

Government

Website

http://www.pt-dlr.de

Funders

Funder type

Government

Funder name

Federal Ministry of Education and Research (BMBF) (Germany) (Registration number: 01EL0607)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes