Evaluation of the Impact of a Comic-based Programme to Promote Body Confidence Among Adolescents in India
Condition: Body Image; Eating Disorder Symptom
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Body dissatisfaction is a leading concern for young people and can have serious health
      consequences. Emerging approaches for improving body image are effective among adolescents in
      the school setting. However, the majority of trials are conducted in high-income westernised
      countries, despite body dissatisfaction being increasingly recognised as a global concern. As
      such, it is important to develop and disseminate interventions to promote body confidence
      among adolescents in in low-to-middle income countries, too.

      One country where body image concerns are becoming an increasing issue is India. The
      investigators recently finished developing and evaluating a body image programme among
      adolescents in New Delhi, India; which found immediate and 3-month improvements in body
      image, disordered eating, self-esteem, and other related outcomes. Whilst these findings
      offer an effective body image programme for school students in urban areas of India, this may
      not be feasible for schools in more rural and lower socio-economic areas in India.

      The aim of the present study is therefore to conduct an acceptability study, followed by a
      randomised controlled trial (RCT), of a comics-based body image programme among adolescents
      in a semi-rural area of India (Rajasthan), in order to understand its acceptability,
      feasibility, and preliminary efficacy. This comic-based programme will be based on Dove
      Confident Me, which was found to be effective among adolescents in Delhi, India.

      To assess the acceptability of the comic-book-based programme, interviews and focus groups
      will be conducted with students and teachers. This in-depth feedback will be used to optimise
      the programme. Next, an RCT will compare body image and well-being of students who take part
      in the programme to students who do not take part (classes as usual) to examine the
      programme's efficacy. The investigators will recruit students and teachers from schools in a
      rural and lower socio-economic area of India (Rajasthan). Students will complete
      questionnaire assessments of body image and well-being before and after the 6-session
      intervention (across 4 weeks), and again at 3-month follow-up to assess longer-term benefits.

      It is hypothesised that students who receive the intervention will have better body image and
      wellbeing relative to the control group at both post-intervention and follow-up.
    

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 national survey of nearly 22,000 young
      people in Australia found that 3 in 10 adolescent boys and girls are concerned about their
      appearance. This high prevalence of body image concerns is worrisome, given their serious
      negative physical and psychological health consequences, including unhealthy weight loss
      behaviours, eating disorders, depression and self-harm, substance use, and lower levels of
      academic engagement.

      There is increasing recognition that body dissatisfaction is a global issue. For example, in
      India, 57% of adolescents report being concerned with their appearance. Further, 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. Indeed, research indicated 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. The investigators
      recently finished developing and evaluating a school-based body image programme, 'Dove
      Confident Me', among adolescents in New Delhi, India. Immediate and 3-month follow-up
      improvements were found in body image, disordered eating, self-esteem, and other related
      outcomes. Whilst these findings offer an effective body image programme for school students
      in urban areas of India, this may not be feasible for schools in more rural and lower
      socio-economic areas in India, where there is limited electricity and computers.

      Therefore, the aim of the present study is to conduct an acceptability study followed by a
      randomised controlled trial of a comic-based body image programme among adolescents in a
      semi-rural area of India (Rajasthan), in order to understand its acceptability, feasibility,
      and preliminary efficacy. This comic-book-based programme will be based on 'Dove Confident
      Me'.

      It is hypothesised that students who receive the comic-based body image intervention will
      experience immediate and sustained improvements in the primary (i.e., body image) and
      secondary outcomes (i.e., eating pathology, internalisation of appearance ideals, body
      image-related life disengagement, self-esteem, positive and negative mood) relative to
      students in the control condition. There are no hypotheses in relation to the impact of the
      intervention on the exploratory outcomes (I.e., skin colour dissatisfaction, body hair
      dissatisfaction, appearance-based teasing, endorsement of traditional gender norms).

      Study 1: Acceptability study

      Study design

      A qualitative approach will be adopted to explore students' and teachers' acceptability
      (i.e., thoughts and feedback) on the comics. Online interviews will be conducted with
      students, whilst online focus groups will be conducted with teachers, both informed by a
      semi-structured interview schedule. All participants will also be asked a series of
      quantitative questions exploring acceptability of the comics.

      Recruitment and participants

      The Department of Education in Rajasthan will select one school which meets the inclusion
      criteria to participate in the research (see elsewhere). A total of nine teachers who teach
      across Classes 6-8 (three teachers from each year group) will be invited to participate in an
      online focus group (five teachers in one focus group, four teachers in a second focus group).
      However, a total of 36 students across Classes 6-8 (aged 11-14 years) will be invited to
      participate in online interviews, whereby the first nine interviews will help in theme
      identification and the remaining 27 interviews will contribute towards developing a greater
      understanding of each theme. This sample will be equally divided across the three years,
      genders, and reading and writing proficiency, which will be assessed by their teachers. This
      will lead to six girls and six boys in each year group, with three boys and three girls with
      a higher level of reading and writing proficiency, and three boys and three girls with a
      lower level of reading and writing proficiency.

      Procedure

      On behalf of the authors, who are unable to travel to India due to the COVID-19 pandemic, an
      International Organization for Standardisation-(ISO)-certified research agency will collect
      data. Once parents have provided consent for their children to participate in the study,
      students will provide informed assent. Teachers will be provided with information about the
      study and a consent form. Next, each participant will be sent a copy of the six comics to
      read at home. A week later, the research agency will conduct the online focus groups with
      teachers and online interviews with students. The interviews and focus groups will be
      audio-recorded and last between 45-60 minutes. Participants will then be asked to complete
      the brief quantitative questionnaire.

      Data analysis

      A Data Management Plan will be prepared in line with requirements of university research
      governance. Audio-recordings will be transcribed verbatim and anonymized. Transcripts will be
      simultaneously analysed by two of the authors using qualitative codebook thematic analysis.
      Questionnaire data will be entered into an SPSS file, and descriptive analyses will be
      conducted on the data. Findings from both the qualitative and quantitative data will be used
      to optimise the comics and Teacher Guides prior to their evaluation in the randomised
      controlled trial (RCT).

      Study 2: RCT

      Trial design

      A parallel two-arm, cluster RCT will be employed to evaluate the AdhaFULL comic-based
      intervention. Schools will be randomized before completion of T1 data collection. The study
      design comprises two independent groups with outcome data collected at three time points (T1,
      T2, T3). T1 is baseline (Week 1); T2 is 1-week post-intervention (Week 5) at the end of
      intervention; T3 is 12-weeks follow-up (Week 16). The resulting data is amenable to standard
      analysis for two group comparisons including a 2 by 2 by 2 by mixed factorial design with
      randomized group as a two level between subjects fixed factor, trial phase (T2, T3) as a
      longitudinal two-level repeated measures factor, gender as a two-level fixed factor and with
      the commensurate baseline measure (T1) as a mean adjusted covariate. Randomized school will
      be a random factor in the analyses. Following T3 data collection, schools in the control
      condition will receive all intervention materials, including the training documents for
      teachers.

      Recruitment and participants

      Government schools in Rajasthan will be recruited using stratified sampling based on two key
      sociodemographic factors: the degree of ruralness of the area within which the school is
      located, the school's exam results. The main recruitment sites will be identified by
      Rajasthan's Department of Education, who will select schools that meet the inclusion criteria
      (see elsewhere). Once the school principal provides consent to participate in the research,
      each school will be randomly allocated to either the intervention or lessons-as-usual control
      condition. Students in Classes 6-8 (aged 11 to 14 years) will be invited to participate in
      the study.

      Sample size calculations

      The evaluation of 'Dove Confident Me' in an urban Indian setting indicated a range of effect
      sizes for outcome measures with standardized effects in the small to medium range and
      exceeding an effect size of d = 0.2, which would minimally be of interest to public health
      policy makers (Lewis-Smith et al., Under review). For a lower bound of d = 0.2, a sample size
      of n = 540 boys and n = 540 girls per arm would have 95% power to detect an effect separately
      for each gender (two-sided, alpha = 0.05). To account for 10% loss, the sample size will be
      inflated by (540/10 =) 54 of each gender per arm, and to account for 10% loss within this
      additional recruitment, a further inflation of (54/10 =) 6 to give a target sample size of
      600 boys and 600 girls per arm, totalling 1,200 per arm (intervention versus control).
      Therefore, a total of 2,400 students will be recruited. Students will be equally divided
      across years 6,7, and 8, and gender.

      Randomization

      Participants will be randomized to either the intervention or control arm at the school
      level. Randomization will be conducted at the school level to avoid spill over effects due to
      communication about the intervention to the control group. Eligible schools will be
      randomised in a target 1:1 ratio using minimization with a residual error. The minimization
      factors are (i) number of students at grade 6, 7 or 8 and (ii) proportion of boys at grade 6,
      7, and 8. The first 8 schools will be allocated using blocked randomisation thereafter
      probabilistic minimization will occur with the probability of minimizing set to 0.8.

      Outcome measures

      There are very few body image and related psychological outcome measures which have undergone
      rigorous validation in India, and those which have, tend to be in English. The outcome
      measures that will be used in this trial are currently being validated in Hindi by the
      investigators, with rigorous steps employed (Swami & Barron, 2019). The validation will be
      completed prior to commencing the present study. Thus, the final items may differ from those
      in the original scales below and will be reported in the main trial paper (see outcome
      measures elsewhere).

      Since the original protocol, concerns regarding the sample's ability to comprehend the
      measures led to the addition of more visual and less literacy-dependent exploratory measures,
      which are described under the 'Outcome Measures' section.

      Other measures

      Demographics

      Demographic information will be collected from students in the T1 questionnaire, including
      age, gender, religion, language spoken at home, the family's primary wage earner's level of
      education, parents' occupations, number of bedrooms in the house, and whether certain
      electronic items are owned by the household (e.g., television, computer). The socio-economic
      status of participants will be estimated using India's New Consumer Classification System
      (NCCS; Kakati & Ahmed, 2016).

      Intervention acceptability

      Acceptability of the comic-based intervention will again be assessed among students in the
      intervention condition via the T2 questionnaire. They will be asked to indicate their degree
      of agreement or disagreement using a five-point Likert scale (1 = Strongly disagree to 5 =
      Strongly agree) with statements concerning their perceptions of the intervention (e.g., "I
      enjoyed the lessons", "I understood what was being taught in the lessons", "I think
      adolescents would find the activities beneficial and interesting"). Teachers will also be
      asked to complete a brief questionnaire to assess intervention acceptability. They will be
      asked to indicate their degree of agreement or disagreement using a five-point Likert scale
      (1 = Strongly disagree to 5 = Strongly agree) with statements regarding their perceptions of
      intervention delivery and student engagement (e.g., "I enjoyed delivering these lessons",
      "Students understood the key messages of these lessons", "I felt confident delivering these
      sessions"). A subgroup of teachers and students will be invited to participate in separate
      focus groups or interviews, to explore intervention acceptability in greater depth from both
      perspectives.

      Attention checks

      To assess the degree of attention from participants whilst completing each questionnaire,
      attention checks will be embedded throughout at all three time-points. These items will
      instruct participants to select a specific response on a Likert scale (e.g., Please select
      'Strongly Agree'). There will also be attention checks which are specific to each comic's
      storyline in the T2 survey. These will be used to assess participants' recall of the comics
      and to determine the number of participants that were present in each session. There will be
      a question about each comic (e.g., "Why does Seema's mother stop her from playing outside?"),
      to which participants will need to select the correct answer from four options (e.g., "she
      wants Seema to study for school", "she says it's too dark to play outside", "I did not attend
      Session 1/do not recognize the story").

      Intervention fidelity A proportion of sessions will be observed by researchers, and teachers
      will be asked to audio-record the delivery of their sessions. Fidelity assessment will be
      based on previous school intervention evaluation studies (Garbett et al., 2021; Diedrichs et
      al., 2021), whereby a standardised checklist will assess three domains: perceived facilitator
      competence, the extent to which learning outcomes were met, and adherence to the
      intervention. Sessions with both audio and live observation will be used to assess interrater
      reliability.

      Procedure

      Ethical guidelines for conducting anonymous public health research in India (Indian Council
      of Medical Research, 2018) indicate that parental consent is sought at the school's
      discretion. However, with the permission of Department of Education of Rajasthan in India,
      parents will be given two weeks to provide opt-out consent. Additionally, the children will
      be provided with information about the study and given the opportunity to ask questions
      before they indicate written assent. The research agency will liaise with each recruited
      school to decide on an alternative activity for the students without consent/assent. This
      will take place outside of the classroom where the intervention is being delivered or data
      collection is occurring. Once all consent procedures have been completed, a team of trained
      researchers from an ISO-certified research agency will administer T1 outcome assessments via
      a self-report paper survey with all students irrespective of randomized arm. All students
      will complete the surveys in a quiet classroom in the presence of a researcher and
      schoolteacher and will be encouraged to complete the questions independently (T1). Further
      outcome assessments will be administered via paper questionnaires in the week following the
      final session of the intervention (T2) and at 12-weeks follow-up (T3). Once outcome
      assessments have been completed by students, the data will be entered into a
      password-protected Excel spreadsheet, and subsequently imported into an SPSS data file for
      analysis. A Data Management Plan will be prepared in line with requirements of university
      research governance. This data will be stored on a secure encrypted network on the university
      system.

      With regard to intervention delivery, a 'train-the-trainer' approach will be adopted. This
      will involve having expert trainers (i.e, the authors, who are experienced in the
      train-the-trainer approach) teach non-expert providers (i.e., the research agency) how to
      subsequently train teachers in delivery of the intervention. The train-the-teacher approach
      has demonstrated efficacy in previous body image intervention evaluations and facilitates
      scalability and sustainability. The research agency will receive a two-day training course,
      and subsequently, teachers will receive a one-day training course. The teacher training will
      cover the theoretical basis of the intervention, including risk factors for body
      dissatisfaction, and the associated consequences. Subsequently, the teachers will be
      familiarised with the comics and associated activities and will participate in role plays to
      practise delivering the intervention. Finally, they will be given hints and tips for
      delivering the sessions and practise answering challenging questions that could be posed by
      the students. All schools in the intervention condition will begin the intervention in the
      week following T1 outcome assessment. Teachers will deliver each session during a school
      lesson, and the six sessions will be delivered at a rate of two sessions per week. Each
      session will begin with the teacher reading the comic with the class. When finished, the
      teacher will ask the students for their feedback on the comic and clarify any words/sentences
      that students struggled to understand. Following this, the two activities (activity one being
      mandatory and activity two optional) associated with the respective comic will take place,
      with the teacher facilitating these. Once discussed and completed, the session will come to
      an end.

      Statistical analyses

      The full prospective Statistical Analysis Plan is summarised. Analyses will be conducted on
      an Intention-to-Treat (ITT) basis. Additional per protocol (PP) analyses will be performed.
      The per protocol analysis set will comprise those who provide outcome data and pass attention
      control checks requiring >= 80% of all attention control questions to be correctly answered.
      Missing data sensitivity analyses will be performed on both the ITT analysis set and the PP
      analysis set.

      The primary outcome variable is the BESAA. The analysis plan for the secondary outcomes of
      the EDE-Q, Internalisation-General, BILD-Q, PANAS-C and RSES, and the exploratory outcome of
      endorsement of traditional gender norms will be the same as the BESAA. A linear mixed model
      will be used to examine the 2 by 2 by 2 factorial design (Randomized Arm [Control,
      Intervention], Phase [T2, T3], Gender [Male, Female]) using a hierarchically balanced model
      comprising all two-way interactions and two-way interactions with the baseline mean adjusted
      covariate. The model will additionally include school as a random factor, and a sensitivity
      analysis relating to the inclusion-exclusion of this effect will be conducted. Underpinning
      model assumptions will be examined. ANCOVA with mean adjusted baseline measure as covariate
      will be used to compare randomized arms at each of T2 and T3. The homogeneity of regression
      lines assumption will be assessed. In addition, separate sub-group analyses for boys and
      girls will be performed. Cohen's d and partial eta squared will be used to quantify
      standardised effect size, along with unadjusted means and 95% confidence intervals.
      Percentages reporting positive change, no change, and a poorer outcome, along with 95%
      confidence intervals will be reported. This study has multiple outcome measures (MOMs) at
      multiple time points. To limit serendipitous conclusions from MOMs, we will additionally
      report unadjusted p-values of the secondary outcomes at each of T2 and T3 along with results
      after controlling the False Discovery Rate (Benjamini & Hochberg, FDR using 0.2) and commit
      to reflecting this in the conclusions.

      Exploratory analyses Exploratory outcome measures of skin colour dissatisfaction, body hair
      dissatisfaction, and appearance-based teasing, are single ordinal exploratory outcomes and
      will be compared between randomized groups at each of T2 and T3 using an ordinal logistic
      link controlling for baseline measures. Gender sub-group analyses will also be conducted.

      Additionally, mediation analysis will be used to investigate whether interventional changes
      in Body Esteem between T1 and T3, and Body Esteem at T3, are mediated by changes in
      internalisation of appearance ideals between T1 and T2, and whether mediation is gender
      dependent.

      EXTRA ANALYSES: Exploratory visual-based outcome measures of body size satisfaction and skin
      colour satisfaction are single ordinal exploratory outcomes and will be compared between
      randomized groups at each of T2 and T3 using an ordinal logistic link controlling for
      baseline measures. Gender sub-group analyses will also be conducted.
    

Intervention name(s): AdhaFULL body image comics
Intervention type(s): Behavioral
Intervention description(s): The comics were co-created with the expertise of four stakeholders: the investigators, UNICEF, BBC Media Action, and the Dove Self-Esteem Project. There are six different comics, which target issues relating to gender stereotypes and appearance concerns amongst adolescents in rural India. Based on 'Dove Confident Me', each comic tells a story which targets a specific established risk factor for body dissatisfaction. Specifically, they focus on gender prejudice (Comic 1), societal appearance ideals (Comic 2), media literacy (Comic 3), appearance comparisons (Comic 4), appearance-related conversations and teasing (Comic 5), and promoting 'body activism' (Comic 6). In each session, students will read the respective comic as a class. At the end of each comic, the teacher will facilitate one or two activities with the students based on the key learnings from the comics. These activities will encourage students to think critically about what they have read and consolidate their learning.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel 2-arm cluster randomised controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention