<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286478</url>
  </required_header>
  <id_info>
    <org_study_id>SFS-16-001</org_study_id>
    <nct_id>NCT03286478</nct_id>
  </id_info>
  <brief_title>A Trial of Three School-based Body Image Interventions Delivered by Teachers</brief_title>
  <official_title>A Cluster Randomised Controlled Trial of Three School-based Body Image Interventions Delivered by Teachers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the West of England</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the West of England</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Body image is one of the leading concerns for young people. Such concerns can have serious&#xD;
      health consequences, including unhealthy weight control and exercise behaviours, depression,&#xD;
      smoking, low self-esteem and misusing drugs and alcohol. Leading and emerging approaches for&#xD;
      improving body image are effective among older adolescent females, and when delivered by&#xD;
      expert providers (e.g., psychologists). However, there is a need for body image programmes&#xD;
      that include males and so can be delivered in co-educational settings, and can be delivered&#xD;
      by non-expert providers (e.g., teachers within schools) to facilitate cost-effective and&#xD;
      ongoing use.&#xD;
&#xD;
      This project will evaluate three classroom-based programmes for improving young people's body&#xD;
      image, delivered by class teachers to girls and boys aged 13-14 years in secondary schools.&#xD;
      Two programmes are based on leading (cognitive dissonance) and emerging (mindfulness)&#xD;
      approaches for improving body image, but which have not been previously evaluated with both&#xD;
      boys and girls and when delivered by teachers. The third programme has previously&#xD;
      demonstrated effectiveness in improving body image when delivered by teachers to boys and&#xD;
      girls in the classroom setting, and therefore will provide a useful comparison to benchmark&#xD;
      these programmes.&#xD;
&#xD;
      To assess the impact of each programme, the current study will compare the body image and&#xD;
      well-being of students who take part in each programme to students who take part in an&#xD;
      alternative programme, and those who do not take part in any programme (classes as usual),&#xD;
      over a 6-month period. The investigators will also assess the extent to which gender and&#xD;
      pre-existing levels of body image concerns impacts the benefit received from taking part in&#xD;
      the lessons. To undertake this project, the investigators will recruit students and teachers&#xD;
      from 24 schools in Bristol and surrounding areas in the South West of England. Students will&#xD;
      complete questionnaire assessments of body image and well-being before and after the 5-week&#xD;
      programme period, and again 6 months later to assess longer-term benefits. The investigators&#xD;
      will also gain in-depth feedback from students and teachers via focus groups and interviews,&#xD;
      in order to inform future improvement of the programmes for wider implementation.&#xD;
&#xD;
      Therefore, this trial will assess whether the two newly adapted programmes result in improved&#xD;
      body image compared to those who receive their classes as usual, and compared to an existing&#xD;
      teacher-led programme.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Body image is recognised as an important public health issue by governments, policy-makers,&#xD;
      and health professionals. Poor body image is associated with engagement in unhealthy weight&#xD;
      loss behaviours, depression, reduced academic performance, and has been established as an&#xD;
      important risk factor in the development eating disorders. Within Western societies, poor&#xD;
      body image is also common, with an estimated 25-61% of adolescent girls and boys being&#xD;
      dissatisfied with their appearance. This underlines the importance of prevention and early&#xD;
      intervention. As such, researchers, governments and health professionals are increasingly&#xD;
      seeking effective evidence-based body image interventions that can be disseminated to the&#xD;
      public, in a bid to reduce body image concerns and other adverse negative health related&#xD;
      effects such as eating disorders. However, widespread dissemination of these programmes&#xD;
      remains a challenge due to the difficulty of reaching individuals at risk, the traditional&#xD;
      focus on females only, and the reliance on expert intervention facilitators.&#xD;
&#xD;
      Although it can be difficult reaching those at risk with individual targeted prevention&#xD;
      programs, school-based interventions provide a useful opportunity to reach large and diverse&#xD;
      groups of children and young people, crossing all levels of risk and gaining access to those&#xD;
      who may otherwise not receive necessary intervention. Effective school-based interventions&#xD;
      are designed to reduce the presence or influence of risk factors for body image concerns&#xD;
      (e.g., internalisation of appearance ideals, appearance pressures from friends, family and&#xD;
      the media, appearance-related teasing and bullying, and negative emotions such as depression&#xD;
      and anxiety) in an effort to promote healthy body image. Previous school-based work has&#xD;
      demonstrated some success in reducing body concerns at the conclusion of program&#xD;
      implementation and over meaningful follow-up periods, with evidence showing media literacy&#xD;
      and cognitive dissonance approaches to be useful in this context. However, there is still&#xD;
      room for improvement in the magnitude of effects for universal programmes, and the majority&#xD;
      are still targeted at girls and led by expert facilitators. Consequently, further evaluation&#xD;
      of different approaches in this setting is required.&#xD;
&#xD;
      In addition, another factor which is still rather mixed within the literature, and has an&#xD;
      impact on how universal programmes are delivered, is regarding the use of expert-led versus&#xD;
      teacher-led interventions. Previous reviews have shown that programs are more effective when&#xD;
      facilitated by dedicated expert interventionists. However, evidence from previous studies&#xD;
      conducted by the investigators supports the notion that teachers can deliver a body image&#xD;
      intervention effectively with minimal training. Hence, more research is needed to understand&#xD;
      the effectiveness of teacher led interventions further, as successful task-shifting to&#xD;
      non-expert providers has been identified as an important goal for disseminating mental health&#xD;
      interventions at scale.&#xD;
&#xD;
      Therefore, the aim of this research is to evaluate the efficacy and acceptability of adapted&#xD;
      interventions based on mindfulness and cognitive dissonance, respectively, for delivery to&#xD;
      adolescent girls and boys (aged 13-14 years) by trained teachers. They will be compared&#xD;
      against an existing universal intervention with support for teacher-led delivery and a&#xD;
      class-as-usual control group.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This study will be a parallel 4-arm cluster randomised controlled trial. Schools will be&#xD;
      randomly allocated to receive either the cognitive dissonance, mindfulness, or Dove Confident&#xD;
      Me interventions, or classes-as-usual (control). The intervention duration is the same for&#xD;
      all experimental conditions, and students will be assessed on body image and related outcomes&#xD;
      at baseline, post-intervention, and 6-month follow-up (with 12-month planned pending further&#xD;
      funding).&#xD;
&#xD;
      Participants, recruitment, and allocation:&#xD;
&#xD;
      Sample size for our repeated measures design was determined a priori. Assuming a small effect&#xD;
      size of Cohen's d = .2 based on previous research of teacher-led programmes, a medium&#xD;
      intra-individual correlation between repeated measures of .5, and setting power at .80, the&#xD;
      sample size required to detect significance at the 5% level under individual randomisation&#xD;
      was 294 students per arm. Applying an inflation factor to account for school level clustering&#xD;
      based on a small intraclass correlation coefficient (ICC) of .01 (informed by previous&#xD;
      studies), increased this requirement to 585 students per arm. Based on an average of 100&#xD;
      students from Grade 9 classes per school, the investigators aim to recruit 6 schools per arm.&#xD;
      Thus the investigators aim to recruit 24 secondary schools in total (N = 2400 students) from&#xD;
      Bristol and surrounding areas (UK).&#xD;
&#xD;
      Schools will be initially invited to take part via email and phone, and via involvement in a&#xD;
      wider programme aimed at facilitating greater participation in higher education run by the&#xD;
      Widening Participation team at the host institution. Allocation will be undertaken using&#xD;
      restricted randomisation based on minimisation in order to achieve balance in each of the&#xD;
      arms with regard to key school characteristics (geographical region, socioeconomic status,&#xD;
      proportion of students learning English as a second language). This is the recommended&#xD;
      approach for cluster randomised controlled trials (RCTs) that recruit and allocate&#xD;
      sequentially, and will be implemented using freely available computer software (Minim).&#xD;
&#xD;
      Interventions:&#xD;
&#xD;
      Dove Confident Me&#xD;
&#xD;
      Dove Confident Me represents an existing school-based intervention that targets multiple risk&#xD;
      factors for body dissatisfaction, addressing the nature and source of societal appearance&#xD;
      ideals, media literacy, appearance-related social comparisons, appearance-related&#xD;
      conversations and teasing, and encouraging 'body activism' to challenge appearance pressures.&#xD;
      It consists of five 45-minute interactive lessons, designed to be delivered by teachers in&#xD;
      school classrooms. The intervention was an adaptation of an existing evidence-based&#xD;
      expert-led programme, Happy Being Me. Standardised materials include a detailed lesson plan&#xD;
      for teachers, PowerPoint slides, video clips, and student activity sheets. Intervention&#xD;
      materials are freely available online in five languages (selfesteem.dove.com).&#xD;
&#xD;
      Cognitive dissonance&#xD;
&#xD;
      Cognitive dissonance is conceptualised as the psychological discomfort stemming from&#xD;
      conflicting cognitions and behaviours. Inducing such a state can be used to shift targeted&#xD;
      attitudes and behaviours, as individuals are motivated to do so order regain equilibrium. In&#xD;
      the context of body image and eating disorder prevention, dissonance-based interventions&#xD;
      (DBIs) encourage a voluntary counter-attitudinal stance against socially prescribed&#xD;
      appearance ideals in order to produce a conflict with, and therefore reduce, internalization&#xD;
      of such ideals and their consequences. An existing school-based dissonance intervention which&#xD;
      was previously tested among early adolescent girls with psychologist delivery has been&#xD;
      adapted for delivery to mixed-gender adolescents by trained teachers. It has been designed to&#xD;
      follow the same format and length as Dove Confident Me, and therefore consists of 5 x&#xD;
      45minute lessons, with detailed lesson plans for teachers, accompanying Powerpoint&#xD;
      presentations and student activity sheets.&#xD;
&#xD;
      Mindfulness&#xD;
&#xD;
      Mindfulness refers to the awareness and acceptance of present-moment experience. As a&#xD;
      psychological technique, it is growing in support for treating a range of mental health&#xD;
      concerns. Mindfulness based interventions (MBI) are the next potential alternative to&#xD;
      cognitive dissonance interventions (CDI) as they represent a potentially useful strategy for&#xD;
      promoting positive body image. In this context, MBIs aim to both increase the capacity to&#xD;
      refrain from automatic responses when confronted with appearance ideals and related&#xD;
      sociocultural pressures, and reduce the intensity and impact of negative experiences if and&#xD;
      when they do occur. An existing school-based mindfulness intervention which the investigators&#xD;
      have previously tested among older adolescent girls with psychologist delivery has been&#xD;
      adapted for delivery to adolescent girls and boys by trained teachers. It has been designed&#xD;
      to follow the same format and length as Dove Confident Me, and therefore consists of 5 x&#xD;
      45minute lessons, with detailed lesson plans for teachers, accompanying Powerpoint&#xD;
      presentations and student activity sheets.&#xD;
&#xD;
      Procedure Informed active consent will be obtained from school senior management (during&#xD;
      recruitment), informed assent from parents (prior to baseline assessment), and informed&#xD;
      consent from students (at baseline assessment). Prior to lesson delivery, school teachers&#xD;
      will be trained in their allocated intervention by expert body image researchers (2 x 1.5hr&#xD;
      sessions), and will be provided with all teaching materials necessary for delivering the&#xD;
      interventions. Students will complete questionnaires under standardised conditions supervised&#xD;
      by their teachers and trained research staff. Approximately one week following baseline&#xD;
      questionnaires, intervention schools will deliver their allocated intervention, facilitated&#xD;
      by schoolteachers to whole classes (one lesson per week over five weeks), with a ratio of one&#xD;
      teacher to 20-30 students. All lessons will be audio-recorded and a selection of lessons will&#xD;
      be observed live by trained research staff, for the purposes of assessing fidelity to the&#xD;
      intervention manuals. Teachers and selected students will take part in focus group interviews&#xD;
      following completion of the lessons, in order to obtain qualitative feedback. Students in&#xD;
      control schools will take part part in their usual scheduled lessons. All students will then&#xD;
      complete follow-up questionnaires at post-intervention (within one week of final lesson), and&#xD;
      6-month follow-up. Blinding of students, teachers, and researchers is not possible due to the&#xD;
      nature of the interventions. However, risk of bias from teachers and researchers is minimised&#xD;
      due to anonymous self-report assessments. Risk of contagion is also minimised by randomising&#xD;
      at the school level. Participating schools will receive a £200 honorarium upon project&#xD;
      completion. This project has received ethical approval from the University of the West of&#xD;
      England's Faculty Research Ethics Committee (HAS.16.09.016).&#xD;
&#xD;
      Statistical analysis plan:&#xD;
&#xD;
      Multiple imputation will be used to handle missing data. Analysis of intervention effects&#xD;
      will be conducted using an intent-to-treat approach, with a sensitivity analysis conducted&#xD;
      depending on the extent of missing data. Multilevel mixed models will be used to compare&#xD;
      groups at post-intervention and 6-month follow-up on primary and secondary outcomes,&#xD;
      accounting for the clustered nature of the design (repeated measures within students, within&#xD;
      classes, within schools). Baseline levels of outcomes, as well as demographic and school&#xD;
      characteristics will be used as covariates in order to increase precision of effects.&#xD;
      Follow-up analysis will investigate moderation with respect to gender and baseline body image&#xD;
      concerns, and will be conducted by including interactional terms in the statistical models.&#xD;
      Subsequent mediational analyses following recommendations by Kraemer will investigate&#xD;
      hypothesised mechanisms of change in each of the trial arms. An analysis of&#xD;
      cost-effectiveness will also be undertaken, comparing relative effectiveness across&#xD;
      interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel 4-arm cluster randomised controlled trial.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Masking not possible within design.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in baseline body esteem over time</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of global body image using the Body Esteem Scale for Adolescents and Adults, 5-point Likert-type scale, 18 items</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in baseline body satisfaction over time</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of body dissatisfaction with specific body parts using the Body Satisfaction (Project Eat III), 5 point Likert-type scale, 14 items</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in eating pathology over time</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of eating disorder psychopathology using Eating Disorder Examination-Questionnaire-Short, 4 point Likert-type scale, 12 items</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sociocultural Attitudes Towards Appearance Questionnaire-3 (Internalisation subscale)</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of internalisation of appearance ideals (proposed mediator of The Body Project), 5 point Likert-type scale, 9 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive Inventory of Mindfulness Experiences-Adolescents</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of mindfulness (proposed mediators of the Mindfulness Mode), 4 point Likert-type scale, 25 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Media Literacy Scale - Commercially generated and Peer-generated subscales</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of media literacy (proposed mediator of Dove Confident Me), 5 point Likert-type scale, 20 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Scale for Children</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of positive and negative emotional states, 5 point Likert-type scale, 10 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Engagement Scale</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of the psychosocial impact of body image concerns, 4 point Likert-type scale, 10 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression, Anxiety and Stress Scales-21</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of mental well-being (depression, anxiety and stress), 4 point Likert-type scale, 21 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol health related quality of life - Youth (EQ-5D-Y)</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Assessment of overall health status in order to calculate Quality Adjusted Life Years, 3-point scale, 5 items, plus a single 100 point item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic achievement</measure>
    <time_frame>Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)</time_frame>
    <description>Self-report two most commonly received school grades (A,B,C,D,E,F, Incomplete)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">2400</enrollment>
  <condition>Body Image</condition>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mindfulness-based body image intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dissonance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive dissonance-based body image intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Confident Me</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dove Confident Me body image intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Classes as usual, assessment-only control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>Mindfulness-based body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.</description>
    <arm_group_label>Mindfulness</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dissonance</intervention_name>
    <description>Dissonance-based body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.</description>
    <arm_group_label>Dissonance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dove Confident Me</intervention_name>
    <description>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.</description>
    <arm_group_label>Confident Me</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (school):&#xD;
&#xD;
          -  Co-educational secondary school&#xD;
&#xD;
          -  Available to include Year 9 classes in the study&#xD;
&#xD;
        Exclusion Criteria (school):&#xD;
&#xD;
          -  Single-sex schools&#xD;
&#xD;
          -  Not available to include Year 9 classes in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa J Atkinson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the West of England</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Phillippa C Diedrichs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the West of England</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of the West of England</name>
      <address>
        <city>Bristol</city>
        <state>Avon</state>
        <zip>Bs16 1QY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26469131</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26052831</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
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  </reference>
  <reference>
    <citation>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.</citation>
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  <reference>
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    <PMID>19200369</PMID>
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  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25524249</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24788281</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24115345</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22853820</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19350648</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12365874</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>body image</keyword>
  <keyword>school</keyword>
  <keyword>adolescence</keyword>
  <keyword>intervention</keyword>
  <keyword>task-shifting</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286478
org study id: SFS-16-001
nct id: NCT03286478
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
Background:

      Body image is recognised as an important public health issue by governments, policy-makers,
      and health professionals. Poor body image is associated with engagement in unhealthy weight
      loss behaviours, depression, reduced academic performance, and has been established as an
      important risk factor in the development eating disorders. Within Western societies, poor
      body image is also common, with an estimated 25-61% of adolescent girls and boys being
      dissatisfied with their appearance. This underlines the importance of prevention and early
      intervention. As such, researchers, governments and health professionals are increasingly
      seeking effective evidence-based body image interventions that can be disseminated to the
      public, in a bid to reduce body image concerns and other adverse negative health related
      effects such as eating disorders. However, widespread dissemination of these programmes
      remains a challenge due to the difficulty of reaching individuals at risk, the traditional
      focus on females only, and the reliance on expert intervention facilitators.

      Although it can be difficult reaching those at risk with individual targeted prevention
      programs, school-based interventions provide a useful opportunity to reach large and diverse
      groups of children and young people, crossing all levels of risk and gaining access to those
      who may otherwise not receive necessary intervention. Effective school-based interventions
      are designed to reduce the presence or influence of risk factors for body image concerns
      (e.g., internalisation of appearance ideals, appearance pressures from friends, family and
      the media, appearance-related teasing and bullying, and negative emotions such as depression
      and anxiety) in an effort to promote healthy body image. Previous school-based work has
      demonstrated some success in reducing body concerns at the conclusion of program
      implementation and over meaningful follow-up periods, with evidence showing media literacy
      and cognitive dissonance approaches to be useful in this context. However, there is still
      room for improvement in the magnitude of effects for universal programmes, and the majority
      are still targeted at girls and led by expert facilitators. Consequently, further evaluation
      of different approaches in this setting is required.

      In addition, another factor which is still rather mixed within the literature, and has an
      impact on how universal programmes are delivered, is regarding the use of expert-led versus
      teacher-led interventions. Previous reviews have shown that programs are more effective when
      facilitated by dedicated expert interventionists. However, evidence from previous studies
      conducted by the investigators supports the notion that teachers can deliver a body image
      intervention effectively with minimal training. Hence, more research is needed to understand
      the effectiveness of teacher led interventions further, as successful task-shifting to
      non-expert providers has been identified as an important goal for disseminating mental health
      interventions at scale.

      Therefore, the aim of this research is to evaluate the efficacy and acceptability of adapted
      interventions based on mindfulness and cognitive dissonance, respectively, for delivery to
      adolescent girls and boys (aged 13-14 years) by trained teachers. They will be compared
      against an existing universal intervention with support for teacher-led delivery and a
      class-as-usual control group.

      Design:

      This study will be a parallel 4-arm cluster randomised controlled trial. Schools will be
      randomly allocated to receive either the cognitive dissonance, mindfulness, or Dove Confident
      Me interventions, or classes-as-usual (control). The intervention duration is the same for
      all experimental conditions, and students will be assessed on body image and related outcomes
      at baseline, post-intervention, and 6-month follow-up (with 12-month planned pending further
      funding).

      Participants, recruitment, and allocation:

      Sample size for our repeated measures design was determined a priori. Assuming a small effect
      size of Cohen's d = .2 based on previous research of teacher-led programmes, a medium
      intra-individual correlation between repeated measures of .5, and setting power at .80, the
      sample size required to detect significance at the 5% level under individual randomisation
      was 294 students per arm. Applying an inflation factor to account for school level clustering
      based on a small intraclass correlation coefficient (ICC) of .01 (informed by previous
      studies), increased this requirement to 585 students per arm. Based on an average of 100
      students from Grade 9 classes per school, the investigators aim to recruit 6 schools per arm.
      Thus the investigators aim to recruit 24 secondary schools in total (N = 2400 students) from
      Bristol and surrounding areas (UK).

      Schools will be initially invited to take part via email and phone, and via involvement in a
      wider programme aimed at facilitating greater participation in higher education run by the
      Widening Participation team at the host institution. Allocation will be undertaken using
      restricted randomisation based on minimisation in order to achieve balance in each of the
      arms with regard to key school characteristics (geographical region, socioeconomic status,
      proportion of students learning English as a second language). This is the recommended
      approach for cluster randomised controlled trials (RCTs) that recruit and allocate
      sequentially, and will be implemented using freely available computer software (Minim).

      Interventions:

      Dove Confident Me

      Dove Confident Me represents an existing school-based intervention that targets multiple risk
      factors for body dissatisfaction, addressing the nature and source of societal appearance
      ideals, media literacy, appearance-related social comparisons, appearance-related
      conversations and teasing, and encouraging 'body activism' to challenge appearance pressures.
      It consists of five 45-minute interactive lessons, designed to be delivered by teachers in
      school classrooms. The intervention was an adaptation of an existing evidence-based
      expert-led programme, Happy Being Me. Standardised materials include a detailed lesson plan
      for teachers, PowerPoint slides, video clips, and student activity sheets. Intervention
      materials are freely available online in five languages (selfesteem.dove.com).

      Cognitive dissonance

      Cognitive dissonance is conceptualised as the psychological discomfort stemming from
      conflicting cognitions and behaviours. Inducing such a state can be used to shift targeted
      attitudes and behaviours, as individuals are motivated to do so order regain equilibrium. In
      the context of body image and eating disorder prevention, dissonance-based interventions
      (DBIs) encourage a voluntary counter-attitudinal stance against socially prescribed
      appearance ideals in order to produce a conflict with, and therefore reduce, internalization
      of such ideals and their consequences. An existing school-based dissonance intervention which
      was previously tested among early adolescent girls with psychologist delivery has been
      adapted for delivery to mixed-gender adolescents by trained teachers. It has been designed to
      follow the same format and length as Dove Confident Me, and therefore consists of 5 x
      45minute lessons, with detailed lesson plans for teachers, accompanying Powerpoint
      presentations and student activity sheets.

      Mindfulness

      Mindfulness refers to the awareness and acceptance of present-moment experience. As a
      psychological technique, it is growing in support for treating a range of mental health
      concerns. Mindfulness based interventions (MBI) are the next potential alternative to
      cognitive dissonance interventions (CDI) as they represent a potentially useful strategy for
      promoting positive body image. In this context, MBIs aim to both increase the capacity to
      refrain from automatic responses when confronted with appearance ideals and related
      sociocultural pressures, and reduce the intensity and impact of negative experiences if and
      when they do occur. An existing school-based mindfulness intervention which the investigators
      have previously tested among older adolescent girls with psychologist delivery has been
      adapted for delivery to adolescent girls and boys by trained teachers. It has been designed
      to follow the same format and length as Dove Confident Me, and therefore consists of 5 x
      45minute lessons, with detailed lesson plans for teachers, accompanying Powerpoint
      presentations and student activity sheets.

      Procedure Informed active consent will be obtained from school senior management (during
      recruitment), informed assent from parents (prior to baseline assessment), and informed
      consent from students (at baseline assessment). Prior to lesson delivery, school teachers
      will be trained in their allocated intervention by expert body image researchers (2 x 1.5hr
      sessions), and will be provided with all teaching materials necessary for delivering the
      interventions. Students will complete questionnaires under standardised conditions supervised
      by their teachers and trained research staff. Approximately one week following baseline
      questionnaires, intervention schools will deliver their allocated intervention, facilitated
      by schoolteachers to whole classes (one lesson per week over five weeks), with a ratio of one
      teacher to 20-30 students. All lessons will be audio-recorded and a selection of lessons will
      be observed live by trained research staff, for the purposes of assessing fidelity to the
      intervention manuals. Teachers and selected students will take part in focus group interviews
      following completion of the lessons, in order to obtain qualitative feedback. Students in
      control schools will take part part in their usual scheduled lessons. All students will then
      complete follow-up questionnaires at post-intervention (within one week of final lesson), and
      6-month follow-up. Blinding of students, teachers, and researchers is not possible due to the
      nature of the interventions. However, risk of bias from teachers and researchers is minimised
      due to anonymous self-report assessments. Risk of contagion is also minimised by randomising
      at the school level. Participating schools will receive a £200 honorarium upon project
      completion. This project has received ethical approval from the University of the West of
      England's Faculty Research Ethics Committee (HAS.16.09.016).

      Statistical analysis plan:

      Multiple imputation will be used to handle missing data. Analysis of intervention effects
      will be conducted using an intent-to-treat approach, with a sensitivity analysis conducted
      depending on the extent of missing data. Multilevel mixed models will be used to compare
      groups at post-intervention and 6-month follow-up on primary and secondary outcomes,
      accounting for the clustered nature of the design (repeated measures within students, within
      classes, within schools). Baseline levels of outcomes, as well as demographic and school
      characteristics will be used as covariates in order to increase precision of effects.
      Follow-up analysis will investigate moderation with respect to gender and baseline body image
      concerns, and will be conducted by including interactional terms in the statistical models.
      Subsequent mediational analyses following recommendations by Kraemer will investigate
      hypothesised mechanisms of change in each of the trial arms. An analysis of
      cost-effectiveness will also be undertaken, comparing relative effectiveness across
      interventions.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel 4-arm cluster randomised controlled trial.
primary purpose: Prevention
masking: None (Open Label)
masking description: Masking not possible within design.
measure: Change in baseline body esteem over time
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of global body image using the Body Esteem Scale for Adolescents and Adults, 5-point Likert-type scale, 18 items
measure: Change in baseline body satisfaction over time
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of body dissatisfaction with specific body parts using the Body Satisfaction (Project Eat III), 5 point Likert-type scale, 14 items
measure: Change in eating pathology over time
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of eating disorder psychopathology using Eating Disorder Examination-Questionnaire-Short, 4 point Likert-type scale, 12 items
measure: Sociocultural Attitudes Towards Appearance Questionnaire-3 (Internalisation subscale)
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of internalisation of appearance ideals (proposed mediator of The Body Project), 5 point Likert-type scale, 9 items
measure: Comprehensive Inventory of Mindfulness Experiences-Adolescents
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of mindfulness (proposed mediators of the Mindfulness Mode), 4 point Likert-type scale, 25 items
measure: Media Literacy Scale - Commercially generated and Peer-generated subscales
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of media literacy (proposed mediator of Dove Confident Me), 5 point Likert-type scale, 20 items
measure: Positive and Negative Affect Scale for Children
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of positive and negative emotional states, 5 point Likert-type scale, 10 items
measure: Life Engagement Scale
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of the psychosocial impact of body image concerns, 4 point Likert-type scale, 10 items
measure: Depression, Anxiety and Stress Scales-21
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of mental well-being (depression, anxiety and stress), 4 point Likert-type scale, 21 items
measure: EuroQol health related quality of life - Youth (EQ-5D-Y)
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Assessment of overall health status in order to calculate Quality Adjusted Life Years, 3-point scale, 5 items, plus a single 100 point item
measure: Academic achievement
time frame: Baseline, post-intervention (6-week), 6-month, 12-month (pending further funding)
description: Self-report two most commonly received school grades (A,B,C,D,E,F, Incomplete)
arm group label: Mindfulness
arm group type: Experimental
description: Mindfulness-based body image intervention
arm group label: Dissonance
arm group type: Experimental
description: Cognitive dissonance-based body image intervention
arm group label: Confident Me
arm group type: Experimental
description: Dove Confident Me body image intervention
arm group label: Control
arm group type: No Intervention
description: Classes as usual, assessment-only control group.
intervention type: Behavioral
intervention name: Mindfulness
description: Mindfulness-based body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.
arm group label: Mindfulness
intervention type: Behavioral
intervention name: Dissonance
description: Dissonance-based body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.
arm group label: Dissonance
intervention type: Behavioral
intervention name: Dove Confident Me
description: 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.
arm group label: Confident Me
criteria: 
gender: All
minimum age: 12 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melissa J Atkinson, PhD
role: Principal Investigator
affiliation: University of the West of England
last name: Phillippa C Diedrichs, PhD
role: Principal Investigator
affiliation: University of the West of England
facility: 
country: United Kingdom
citation: 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: 26469131
citation: 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: 26052831
citation: 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: 27693763
citation: 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: 23683611
citation: 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: 23668845
citation: 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: 23562583
citation: 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: 18506621
citation: 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: 19200369
citation: 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: 20218759
citation: 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: 16857537
citation: 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: 25805217
citation: 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: 24140874
citation: 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: 25524249
citation: 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: 24788281
citation: 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: 24115345
citation: 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: 22853820
citation: 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: 19350648
citation: 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: 12365874
responsible party type: Sponsor
sharing ipd: No