Evaluating Dove Confident Me in India
Condition: Body Image
Study type: Interventional

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
      and self-harm, low self-esteem and substance abuse. Emerging approaches for improving body
      image are effective among adolescent girls and boys in the school setting. However, the vast
      majority of trials in this area are conducted in high-income westernised countries, despite
      body image concerns increasingly being recognised as a global concern. As such, it is
      important to develop and disseminate interventions to promote positive body image among
      adolescents in in low-to-middle income countries, too. 'Confident Me' has been found to be
      effective in improving body image and related outcomes among adolescent girls and boys in the
      UK up to 12-months later, and thus, could undergo adaptations for the Indian context.

      The aim of the present study is two-fold:

        -  To conduct a small-scale acceptability study of a 'Confident Me', a body image
           intervention, among 11-13-year olds in New Delhi, India, to understand its
           acceptability, feasibility, and preliminary efficacy in a metropolitan area of India.

        -  To refine 'Confident Me' based on the acceptability study, and to conduct a randomised
           controlled trial to evaluate its efficacy at improving body image and related outcomes
           among 11-13-year olds in New Delhi, India.

      The first aim will be fulfilled by recruiting two schools, of which one will be randomised to
      the intervention and the other to the control arm. We will compare the body image and
      well-being of students who take part in the programme to students in the control group. The
      investigators will also gather in-depth feedback from students, teachers and the
      interventionist via focus groups and interviews, in order to inform future improvement of the
      programme. The second aim will be fulfilled by randomising six schools to either the revised
      body image programme (3 schools) or the control arm (3 schools). Students will complete
      questionnaire assessments of body image and well-being before and after the 5-week programme
      period, and again 12 weeks later to assess longer-term benefits.
    

Detailed description: 
      Background:

      Body image is a significant and prevalent concern for adolescents in high-income countries
      such as the UK, the USA, and Australia. For example, a study of 1,600 girls in the UK found
      that four in ten 11-16-year-old girls are unhappy with the way they look. Similarly, a
      nationally representative survey of nearly 22,000 young people in Australia found that 3 in
      10 adolescent boys and girls are very concerned about their body image, and body image was
      voted among the top three life concerns. The high prevalence of body image concerns among
      adolescent boys and girls is worrisome, given their serious negative physical and
      psychological health consequences. For example, body dissatisfaction is associated with
      engagement in unhealthy weight loss behaviours and the onset of eating disorders, depression
      and self-harm, substance use, and lower levels of academic engagement.

      There is increasing recognition that body image is a global issue, as opposed to one
      relegated to privileged adolescents in high-income Westernised countries. For example, in
      India, 57% of adolescents aged 15-19 years report being concerned with their appearance.
      Further, adolescent girls across different regions of India have expressed concerns in
      relation to their weight and report dieting behaviours. Skin colour has also been indicated
      as an additional source of appearance concern among young people in India. A large-scale
      study among Asian, African, and South American countries, found that 19% of Indian
      undergraduate students had used a skin lightening product in the previous 12 months, strongly
      suggesting dissatisfaction with their natural skin tone, which may be pertinent to younger
      groups.

      Collectively, these findings indicate the importance of developing and disseminating
      interventions to promote positive body image among adolescents in India. To date, only one
      published study has investigated the effectiveness of a body image intervention delivered in
      schools to adolescents in India. The results indicated the potential for media literacy to
      improve body satisfaction among adolescent girls. While this study offers a promising first
      step, more research is needed to understand the potential for school body image interventions
      in India.

      The aim of the present study is two-fold:

        1. To conduct a small-scale acceptability study of a body image intervention among
           11-13-year olds in New Delhi, India, to understand its acceptability, feasibility, and
           preliminary efficacy in a metropolitan area of India.

        2. To refine the body image intervention based on the acceptability study, and to conduct a
           randomised controlled trial to evaluate its efficacy at improving body image and related
           outcomes among 11-13-year olds in New Delhi, India.

      1) The Acceptability Study

      Design:

      Two schools will be randomly allocated to receive the body image intervention or
      classes-as-usual (control). Students will be assessed on body image and related outcomes at
      baseline, post-intervention and 10 weeks follow-up, under standardised conditions.

      Participants & recruitment:

      Two co-educational secondary schools in Delhi, India, will be invited to take part in this
      study. The collaborators in India will recruit the schools, and they will likely be schools
      with which their institution has existing relations with. All students in classes 6-7
      (equivalent of UK years 7-8; students aged 11-13) in each school will be invited to take
      part.

      After expressing initial interest, each school will receive detailed information regarding
      the aims, objective and requirements of the study to help them decide if they would like to
      take part in this research project. In line with the ethical procedures adopted at the
      collaborators' Indian universities, the school's head teacher will provide active informed
      consent. Students will also be required to provide their consent before taking part. All
      students will have the opportunity to opt out of the study, or withdraw from the study at any
      time, irrespective of head teacher consent. The Indian ethical procedures do not involve
      asking parents to provide consent for their child's participation in the research.

      The exact numbers of students that take part in this research will depend on the number of
      children enrolled in classes 6-7 at each school recruited, and the number that opt out during
      the student consent process or are lost at follow-up due to moving schools, or being away
      from school on the day the data is collected. However, given that this is a preliminary
      acceptability study, both conditions (i.e., schools) will include 80 girls and 80 boys (160
      participants overall) aged 11 to 13 years, which allows for 30% attrition.

      Intervention:

      Dove Confident Me

      Dove Confident Me is a school-based intervention co-created by researchers at La Trobe
      University (Australia), the Centre for Appearance Research UWE, teachers, students, and
      education experts, and the Dove Self-Esteem Project (the social mission for personal care
      brand Dove). The five-session intervention is aimed at adolescents aged between 11-13 years,
      and targets recognised risk factors for body dissatisfaction, by addressing societal
      appearance ideals (Session 1), media literacy (Session 2), appearance comparisons (Session
      3), appearance-related conversations and teasing (Session 4), and promoting 'body activism'
      (Session 5). The intervention consists of classroom-based discussion and small group
      activities and uses audio-visual materials and worksheets to facilitate learning. The content
      is based upon an evidence-based intervention previously trialled among adolescent girls
      (Richardson and Paxton, 2010).

      A large-scale cluster randomised controlled trial (RCT) evaluating Dove Confident Me found it
      to be effective in improving body image and related outcomes among adolescent girls and boys
      in the UK up to 12-months later when delivered by teachers (Diedrichs et al., under review).
      These findings present the longest improvements in body image observed in a teacher-led
      intervention. However, the intervention has not undergone evaluation in low- and middle-
      income countries, such as India, where body image concerns are also prevalent but the
      rigorous development, evaluation, and dissemination, of evidence-based interventions is
      lacking.

      Procedure:

      Investigators from the Centre for Appearance Research (CAR) based at the University of the
      West of England will be leading the study remotely from Bristol, UK. CAR researchers will be
      responsible for designing the study, analysing the data, and writing up the manuscript. They
      will also be working with Indian collaborators who will be responsible for translating the
      measures, recruiting the schools, collecting data, and delivering the intervention.

      Students aged 11-13 from a further two secondary schools in Delhi will be recruited, and
      independent randomisation will be used to assign one school to the intervention condition,
      and the other to the lessons-as-usual control condition. This will be done using freely
      available computer software. Dove Confident Me (culturally adapted and translated into
      Hinglish) will be delivered by counselling psychologists at Karma Centre for Wellbeing in
      Delhi. The interventionists will be trained (in person) by two researchers from CAR on the
      delivery of the intervention. Both of these researchers possess experience of delivering, and
      training others to deliver, a range of body image interventions, including Dove Confident Me.

      A questionnaire comprising the self-report measures described below will be used to assess
      the impact of the intervention on students' body image and associated risk factors. After
      obtaining consent from the school head teachers, and the students, these measures will be
      administered in the classroom to the 11-13 year old students at pre-intervention (1-2 weeks
      before intervention delivery), immediately after intervention delivery (within 1 week of the
      final session), and again at 10 weeks follow-up. The questionnaire will take students no more
      than 20-25 minutes to complete. Students will complete questionnaires under standardised
      conditions supervised by their teachers and trained research staff. Blinding of students,
      teachers, and researchers is not possible due to the nature of the intervention. 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 £150 honorarium. This project has received ethical
      approval from the University of the West of England's Faculty Research Ethics Committee.

      In order to assess the fidelity of the intervention manuals, all sessions will be
      audio-recorded as well as observed by a researcher and rated based on adherence to lesson
      plans. The interventionist and observing teachers also will be asked to complete a brief form
      after each lesson stating which activities were completed.

      To assess intervention feasibility and acceptability, phone calls will be conducted with the
      interventionists after every session, to collect 'in-the-moment' feedback and suggestions for
      improvement to the materials. At the conclusion of the intervention, interviews will be
      conducted with the interventionists to explore their experience of delivering the body image
      lessons. They will also be asked how well the content of the intervention was received, how
      comfortable they felt delivering the session, and their suggestions to improve the
      intervention further. Class teachers observing the lessons will also be interviewed and asked
      similar questions.

      In the post-intervention questionnaire, students will be asked a series of questions to
      assess their acceptability of the intervention. Students will indicate agreement with
      different statements using a 5-point Likert scale, and will be asked three open-ended
      questions: what they liked, what they did not like, and to list three things they learnt from
      the intervention. Additionally, a sub-sample of students (approximately 10 girls, 10 boys) in
      the intervention condition will also be invited to take part in single-gender focus groups,
      in order to explore their opinions of the intervention. Permission to audio record the focus
      groups and interviews will be sought from participants prior to commencing the discussions.

      The findings from this study will then be used to refine the intervention material further,
      to ensure that it is adequately localised to the Indian context.

      2) The Randomised Controlled Trial

      Design:

      Six schools will be randomly allocated to receive the body image intervention or
      classes-as-usual (control). Students will be assessed on body image and related outcomes at
      baseline, post-intervention and 12 weeks follow-up, under standardised conditions.

      Participants & recruitment:

      Six co-educational secondary schools in Delhi, India, will be invited to take part in this
      study. The collaborators in India will recruit the schools, and they will likely be schools
      with which their institution has existing relations with. All students in classes 6-8
      (equivalent of UK years 7-9; students aged 11-14) in each school will be invited to take
      part.

      After expressing initial interest, each school will receive detailed information regarding
      the aims, objective and requirements of the study to help them decide if they would like to
      take part in this research project. In line with the ethical procedures adopted at the
      collaborators' Indian universities, the school's head teacher will provide active informed
      consent. Students will also be required to provide their consent before taking part. All
      students will have the opportunity to opt out of the study, or withdraw from the study at any
      time, irrespective of head teacher consent. The Indian ethical procedures do not involve
      asking parents to provide consent for their child's participation in the research.

      The exact numbers of students that take part in this research will depend on the number of
      children enrolled in classes 6-8 at each school recruited, and the number that opt out during
      the student consent process or are lost at follow-up due to moving schools, or being away
      from school on the day the data is collected. However, we will endeavour to include 125 girls
      and 125 boys (250 participants overall) aged 11 to 14 years, which allows for 30% attrition.

      Procedure:

      Students aged 11-14 from a further six secondary schools in Delhi will be recruited, and
      independent randomisation will be used to assign three schools to the intervention condition,
      and the other three to the lessons-as-usual control condition. This will be done using freely
      available computer software. The refined programme will be delivered by counselling
      psychologists at Karma Centre for Wellbeing in Delhi. The interventionists will be trained
      (in person) by two researchers from CAR on the delivery of the intervention. Both of these
      researchers possess experience of delivering, and training others to deliver, a range of body
      image interventions, including Dove Confident Me.

      A questionnaire comprising the self-report measures described below will be used to assess
      the impact of the intervention on students' body image and associated risk factors. After
      obtaining consent from the school head teachers, and the students, these measures will be
      administered in the classroom to the 11-14 year old students at pre-intervention (1-2 weeks
      before intervention delivery), immediately after intervention delivery (within 1 week of the
      final session), and again at 12 weeks follow-up. The questionnaire will take students no more
      than 20-25 minutes to complete. Students will complete questionnaires under standardised
      conditions supervised by their teachers and trained research staff. Blinding of students,
      teachers, and researchers is not possible due to the nature of the intervention. 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 £150 honorarium. This project has received ethical
      approval from the University of the West of England's Faculty Research Ethics Committee.

      In order to assess the fidelity of the intervention manuals, all sessions will be
      audio-recorded as well as observed by a researcher and rated based on adherence to lesson
      plans. The interventionist and observing teachers also will be asked to complete a brief form
      after each lesson stating which activities were completed.

      To assess intervention feasibility and acceptability, interviews will be conducted with the
      interventionists at the end of the programme to explore their experience of delivering the
      body image lessons.

      In the post-intervention questionnaire, students will be asked a series of questions to
      assess their acceptability of the intervention. Students will indicate agreement with
      different statements using a 5-point Likert scale, and will be asked three open-ended
      questions: what they liked, what they did not like, and to list three things they learnt from
      the intervention.
    

Intervention name(s): Dove Confident Me
Intervention type(s): Behavioral
Intervention description(s): Dove Confident Me is a school-based intervention co-created by researchers at La Trobe University (Australia), the Centre for Appearance Research UWE, teachers, students, and education experts, and the Dove Self-Esteem Project (the social mission for personal care brand Dove). The five-session intervention is aimed at adolescents aged between 11-13 years, and targets recognised risk factors for body dissatisfaction, by addressing societal appearance ideals (Session 1), media literacy (Session 2), appearance comparisons (Session 3), appearance-related conversations and teasing (Session 4), and promoting 'body activism' (Session 5). The intervention consists of classroom-based discussion and small group activities, and uses audio-visual materials and worksheets to facilitate learning.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel 2-arm cluster randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: body image; school; intervention; adolescence; self-esteem