NCT03286478

Brief Summary

Body image is one of the leading concerns for young people. Such concerns can have serious health consequences, including unhealthy weight control and exercise behaviours, depression, smoking, low self-esteem and misusing drugs and alcohol. Leading and emerging approaches for improving body image are effective among older adolescent females, and when delivered by expert providers (e.g., psychologists). However, there is a need for body image programmes that include males and so can be delivered in co-educational settings, and can be delivered by non-expert providers (e.g., teachers within schools) to facilitate cost-effective and ongoing use. This project will evaluate three classroom-based programmes for improving young people's body image, delivered by class teachers to girls and boys aged 13-14 years in secondary schools. Two programmes are based on leading (cognitive dissonance) and emerging (mindfulness) approaches for improving body image, but which have not been previously evaluated with both boys and girls and when delivered by teachers. The third programme has previously demonstrated effectiveness in improving body image when delivered by teachers to boys and girls in the classroom setting, and therefore will provide a useful comparison to benchmark these programmes. To assess the impact of each programme, the current study will compare the body image and well-being of students who take part in each programme to students who take part in an alternative programme, and those who do not take part in any programme (classes as usual), over a 6-month period. The investigators will also assess the extent to which gender and pre-existing levels of body image concerns impacts the benefit received from taking part in the lessons. To undertake this project, the investigators will recruit students and teachers from 24 schools in Bristol and surrounding areas in the South West of England. Students will complete questionnaire assessments of body image and well-being before and after the 5-week programme period, and again 6 months later to assess longer-term benefits. The investigators will also gain in-depth feedback from students and teachers via focus groups and interviews, in order to inform future improvement of the programmes for wider implementation. Therefore, this trial will assess whether the two newly adapted programmes result in improved body image compared to those who receive their classes as usual, and compared to an existing teacher-led programme.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 18, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

September 8, 2017

Last Update Submit

September 19, 2017

Conditions

Keywords

body imageschooladolescenceinterventiontask-shifting

Outcome Measures

Primary Outcomes (3)

  • Change in baseline body esteem over time

    Assessment of global body image using the Body Esteem Scale for Adolescents and Adults, 5-point Likert-type scale, 18 items

    Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)

  • Change in baseline body satisfaction over time

    Assessment of body dissatisfaction with specific body parts using the Body Satisfaction (Project Eat III), 5 point Likert-type scale, 14 items

    Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)

  • Change in eating pathology over time

    Assessment of eating disorder psychopathology using Eating Disorder Examination-Questionnaire-Short, 4 point Likert-type scale, 12 items

    Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)

Secondary Outcomes (8)

  • Sociocultural Attitudes Towards Appearance Questionnaire-3 (Internalisation subscale)

    Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)

  • Comprehensive Inventory of Mindfulness Experiences-Adolescents

    Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)

  • Media Literacy Scale - Commercially generated and Peer-generated subscales

    Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)

  • Positive and Negative Affect Scale for Children

    Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)

  • Life Engagement Scale

    Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)

  • +3 more secondary outcomes

Study Arms (4)

Mindfulness

EXPERIMENTAL

Mindfulness-based body image intervention

Behavioral: Mindfulness

Dissonance

EXPERIMENTAL

Cognitive dissonance-based body image intervention

Behavioral: Dissonance

Confident Me

EXPERIMENTAL

Dove Confident Me body image intervention

Behavioral: Dove Confident Me

Control

NO INTERVENTION

Classes as usual, assessment-only control group.

Interventions

MindfulnessBEHAVIORAL

Mindfulness-based body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.

Mindfulness
DissonanceBEHAVIORAL

Dissonance-based body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.

Dissonance

Dove Confident Me body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.

Confident Me

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Co-educational secondary school
  • Available to include Year 9 classes in the study

You may not qualify if:

  • Single-sex schools
  • Not available to include Year 9 classes in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the West of England

Bristol, Avon, Bs16 1QY, United Kingdom

Location

Related Publications (18)

  • Diedrichs PC, Atkinson MJ, Steer RJ, Garbett KM, Rumsey N, Halliwell E. Effectiveness of a brief school-based body image intervention 'Dove Confident Me: Single Session' when delivered by teachers and researchers: Results from a cluster randomised controlled trial. Behav Res Ther. 2015 Nov;74:94-104. doi: 10.1016/j.brat.2015.09.004. Epub 2015 Sep 30.

    PMID: 26469131BACKGROUND
  • Atkinson MJ, Wade TD. Mindfulness-based prevention for eating disorders: A school-based cluster randomized controlled study. Int J Eat Disord. 2015 Nov;48(7):1024-37. doi: 10.1002/eat.22416. Epub 2015 Jun 6.

    PMID: 26052831BACKGROUND
  • Halliwell E, Yager Z, Paraskeva N, Diedrichs PC, Smith H, White P. Body Image in Primary Schools: A pilot evaluation of a primary school intervention program designed by teachers to improve children's body satisfaction. Body Image. 2016 Dec;19:133-141. doi: 10.1016/j.bodyim.2016.09.002. Epub 2016 Sep 28.

    PMID: 27693763BACKGROUND
  • Yager Z, Diedrichs PC, Ricciardelli LA, Halliwell E. What works in secondary schools? A systematic review of classroom-based body image programs. Body Image. 2013 Jun;10(3):271-81. doi: 10.1016/j.bodyim.2013.04.001. Epub 2013 May 14.

    PMID: 23683611BACKGROUND
  • Halliwell E, Diedrichs PC. Testing a dissonance body image intervention among young girls. Health Psychol. 2014 Feb;33(2):201-4. doi: 10.1037/a0032585. Epub 2013 May 13.

    PMID: 23668845BACKGROUND
  • Bird EL, Halliwell E, Diedrichs PC, Harcourt D. Happy Being Me in the UK: a controlled evaluation of a school-based body image intervention with pre-adolescent children. Body Image. 2013 Jun;10(3):326-34. doi: 10.1016/j.bodyim.2013.02.008. Epub 2013 Apr 3.

    PMID: 23562583BACKGROUND
  • Stice E, Shaw H, Becker CB, Rohde P. Dissonance-based Interventions for the prevention of eating disorders: using persuasion principles to promote health. Prev Sci. 2008 Jun;9(2):114-28. doi: 10.1007/s11121-008-0093-x. Epub 2008 May 28.

    PMID: 18506621BACKGROUND
  • Al Sabbah H, Vereecken CA, Elgar FJ, Nansel T, Aasvee K, Abdeen Z, Ojala K, Ahluwalia N, Maes L. Body weight dissatisfaction and communication with parents among adolescents in 24 countries: international cross-sectional survey. BMC Public Health. 2009 Feb 6;9:52. doi: 10.1186/1471-2458-9-52.

    PMID: 19200369BACKGROUND
  • Xie B, Unger JB, Gallaher P, Johnson CA, Wu Q, Chou CP. Overweight, body image, and depression in Asian and Hispanic adolescents. Am J Health Behav. 2010 Jul-Aug;34(4):476-88. doi: 10.5993/ajhb.34.4.9.

    PMID: 20218759BACKGROUND
  • Neumark-Sztainer D, Paxton SJ, Hannan PJ, Haines J, Story M. Does body satisfaction matter? Five-year longitudinal associations between body satisfaction and health behaviors in adolescent females and males. J Adolesc Health. 2006 Aug;39(2):244-51. doi: 10.1016/j.jadohealth.2005.12.001.

    PMID: 16857537BACKGROUND
  • Halliwell E, Jarman H, McNamara A, Risdon H, Jankowski G. Dissemination of evidence-based body image interventions: A pilot study into the effectiveness of using undergraduate students as interventionists in secondary schools. Body Image. 2015 Jun;14:1-4. doi: 10.1016/j.bodyim.2015.02.002. Epub 2015 Mar 21.

    PMID: 25805217BACKGROUND
  • Atkinson MJ, Wade TD. Enhancing dissemination in selective eating disorders prevention: an investigation of voluntary participation among female university students. Behav Res Ther. 2013 Dec;51(12):806-16. doi: 10.1016/j.brat.2013.09.012. Epub 2013 Oct 9.

    PMID: 24140874BACKGROUND
  • Wilksch SM, Paxton SJ, Byrne SM, Austin SB, McLean SA, Thompson KM, Dorairaj K, Wade TD. Prevention Across the Spectrum: a randomized controlled trial of three programs to reduce risk factors for both eating disorders and obesity. Psychol Med. 2015 Jul;45(9):1811-23. doi: 10.1017/S003329171400289X. Epub 2014 Dec 19.

    PMID: 25524249BACKGROUND
  • Fairburn CG, Patel V. The global dissemination of psychological treatments: a road map for research and practice. Am J Psychiatry. 2014 May;171(5):495-8. doi: 10.1176/appi.ajp.2013.13111546. No abstract available.

    PMID: 24788281BACKGROUND
  • 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 Dec;203(6):428-35. doi: 10.1192/bjp.bp.113.128199. Epub 2013 Oct 10.

    PMID: 24115345BACKGROUND
  • Ivers NM, Halperin IJ, Barnsley J, Grimshaw JM, Shah BR, Tu K, Upshur R, Zwarenstein M. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review. Trials. 2012 Aug 1;13:120. doi: 10.1186/1745-6215-13-120.

    PMID: 22853820BACKGROUND
  • Richardson SM, Paxton SJ. An evaluation of a body image intervention based on risk factors for body dissatisfaction: a controlled study with adolescent girls. Int J Eat Disord. 2010 Mar;43(2):112-22. doi: 10.1002/eat.20682.

    PMID: 19350648BACKGROUND
  • Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002 Oct;59(10):877-83. doi: 10.1001/archpsyc.59.10.877.

    PMID: 12365874BACKGROUND

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melissa J Atkinson, PhD

    University of the West of England

    PRINCIPAL INVESTIGATOR
  • Phillippa C Diedrichs, PhD

    University of the West of England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking not possible within design.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel 4-arm cluster randomised controlled trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 18, 2017

Study Start

September 18, 2017

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

September 20, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations