Condition category
Mental and Behavioural Disorders
Date applied
05/02/2013
Date assigned
19/02/2013
Last edited
12/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ulrike Schmidt

ORCID ID

Contact details

Section of Eating Disorders
Institute of Psychiatry
King's College London
De Crespigny Park
London
SE5 8AF
United Kingdom

Additional identifiers

EudraCT 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

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

Trial setting

Schools

Trial 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/06/2011

Overall trial end date

30/09/2012

Reason abandoned

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

Other

Age group

Child

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk

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, King’s 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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24115345
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28872815

Publication citations

  1. Results

    Sharpe H, Schober I, Treasure J, Schmidt U, Feasibility, acceptability and efficacy of a school-based prevention programme for eating disorders: cluster randomised controlled trial., Br J Psychiatry, 2013, 203, 6, 428-435, doi: 10.1192/bjp.bp.113.128199.

Additional files

Editorial Notes

12/09/2017: Publication reference added.