Plain English Summary
Background and study aims
This study explored ways of preventing eating disorders and tackling body dissatisfaction in young people. Although several school programmes of this sort already exist in the UK, none has been rigorously evaluated to determine whether it is actually helpful for young people. The aim of this study is to see whether students who receive a school intervention called Me, You & Us showed improvements in body esteem, eating habits, the extent to which they buy in to a media ideal of thinness, interactions with friends, mood and self-esteem, compared to their peers in a control group. The study also looks at how much students like these lessons and whether school staff are able to deliver the lessons from a manual they are given.
Who can participate?
All students in years 8 and 9 of participating schools
What does the study involve?
Classes in participants schools are randomly allocated to receive either the Me, You & Us intervention or to continue having their usual curriculum. The Me, You & Us programme involves six 50 minute lessons and is delivered by the participants' usual school teachers. All students are asked to complete a series of questionnaires at three times: before the lessons started, after the lessons finished and three months later. These questionnaires focus on eating habits, body satisfaction, friendships, mood and self-esteem. They take no longer than 45 minutes to complete and are administered by school staff during the normal school day.
What are the possible benefits and risks of participating?
Participants are offered a £10 shopping voucher on completion of the questionnaires as a gesture of appreciation of the time spent taking part. In addition, the school receives £10 per student taking part in recognition of the time and effort required to run the study. There are no risks of physical harm from taking part in this study. There is a small chance that students may find answering questions about eating or body satisfaction to be upsetting. However, students are reminded that they do not have to answer any questions that they do not want to and their teacher is present at all times to provide support if needed.
Where is the study run from?
King's College London (UK)
When is the study starting and how long is it expected to run for?
June 2011 to September 2012
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Ms Helen Sharpe
Helen.sharpe@kcl.ac.uk
2. Prof. Ulrike Schmidt
Ulrike.schmidt@kcl.ac.uk
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Me, You & Us: a programme for preventing eating disorders in UK secondary schools - a cluster randomised controlled trial
Acronym
MYU
Study hypothesis
Main hypothesis:
Students receiving the intervention will show significant improvements in body esteem, internalisation, peer support, appearance conversations, depressive symptoms, self-esteem and eating pathology compared to students in the control group at post-intervention and at a three month follow up.
Subsidiary hypotheses:
1. Students will find the material in the intervention acceptable, in that they will report enjoying the lessons and perceive them as useful.
2. It will be feasible to train usual secondary school teachers to deliver an eating disorder prevention programme from a manual and student workbook with high fidelity.
Ethics approval(s)
King's College London Research Ethics Committee, Psychiatry, Nursing & Midwifery Research Ethics Subcommittee (REF PNM 10 11-96), 03/05/2011
Study design
Single-centre cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
School
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Eating disorders / body dissatisfaction
Intervention
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.
Intervention type
Other
Primary outcome measure
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 measures
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
Overall study start date
01/06/2011
Overall study end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Other
Age group
Child
Sex
Both
Target number of participants
1852
Participant exclusion criteria
Participant exclusion criteria:
1. Lack of parental/carer consent
2. Insufficient English language ability to understand assent procedures or complete questionnaire measures
Recruitment start date
01/06/2011
Recruitment end date
30/09/2012
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
King's College London
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Research and Graduate School Support
King's College London
Floor 5
Waterloo Bridge Wing
Franklin Wilkins Building
150 Stamford Street
London
SE1 9NH
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research scheme (RP-PG-0606-1043)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NIHR Biomedical Research Centre for Mental Health, South London and Maudsley NHS Foundation Trust and Institute of Psychiatry, Kings College London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2013 | Yes | No | |
| Results article | results | 01/08/2017 | Yes | No |