Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ISRCTN |
Last refreshed on:
|
2 October 2017 |
Main ID: |
ISRCTN42594993 |
Date of registration:
|
19/02/2013 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Me, You & Us: a programme for preventing eating disorders in UK secondary schools
|
Scientific title:
|
Me, You & Us: a programme for preventing eating disorders in UK secondary schools - a cluster randomised controlled trial |
Date of first enrolment:
|
01/06/2011 |
Target sample size:
|
1852 |
Recruitment status: |
Completed |
URL:
|
http://isrctn.com/ISRCTN42594993 |
Study type:
|
Interventional |
Study design:
|
Single-centre cluster randomised controlled trial (Prevention)
|
Phase:
|
Not Applicable
|
|
Countries of recruitment
|
United Kingdom
| | | | | | | |
Contacts
|
Name:
|
Ulrike
Schmidt |
Address:
|
Section of Eating Disorders
Institute of Psychiatry
King's College London
De Crespigny Park
SE5 8AF
London
United Kingdom |
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: School inclusion criteria: UK based secondary school with students in years 8 and/or 9
Participant inclusion criteria: student (male or female) in year 8 or 9 in participating secondary school
Exclusion criteria: Participant exclusion criteria: 1. Lack of parental/carer consent 2. Insufficient English language ability to understand assent procedures or complete questionnaire measures
Age minimum:
Age maximum:
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Eating disorders / body dissatisfaction Mental and Behavioural Disorders Eating disorder, unspecified
|
Intervention(s)
|
Participants in classes allocated to the intervention arm received six 50 minute sessions outlined in the Me, You & Us manual, focusing on media literacy, peer interactions, boosting mood and self-esteem. The sessions were delivered as part of the usual school day by teachers in participating schools. Teachers received a two hour training session on the material prior to delivery. Specific content of the sessions can be obtained from the contact details listed below.
Participants in classes allocated to the control arm received no intervention (?curriculum as usual?). Lessons provided will be those usually given by school staff.
|
Primary Outcome(s)
|
Participant self-reported body esteem, assessed by the 23-item Body Esteem Scale for Adolescents and Adults. Questionnaires were administered at baseline, post-intervention and three-month follow-up
|
Secondary Outcome(s)
|
1. Participant self-reported questionnaires assessing: 1.1. Eating pathology (Eating Disorders Diagnostic Scale, 22 items) 1.2. Thin-ideal internalization (Sociocultural Attitudes Towards Appearance Scale ? Internalization, 9 items) 1.3. Appearance conversations with friends (Appearance Conversations with Friends Scale, 5 items) 1.4. Peer support (Multidimensional Scale of Perceived Social Support ? Friends, 4 items) 1.5. Depressive symptoms (Depression, Anxiety and Stress Scale, 21 items) 1.6. Self-esteem (1 item) All questionnaires administered at baseline, post-intervention and three-month follow-up 2. In addition participants provided feedback on the acceptability of the intervention at post-intervention with two self-report items assessing how much students liked the lessons and how helpful they found the lessons 3. Feasibility of the mode of delivery was assessed through observations of two intervention lessons in each participating school, which were rated based on the number of activities outlined in the manual that were completed in the session
|
Source(s) of Monetary Support
|
National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research scheme (RP-PG-0606-1043), NIHR Biomedical Research Centre for Mental Health, South London and Maudsley NHS Foundation Trust and Institute of Psychiatry, King?s College London (UK)
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|