Body dissatisfaction, a primary risk factor for eating disorders, is prevalent among
      adolescents. Given increases in adolescent body dissatisfaction since the Covid-19 pandemic,
      there is a pressing need for universal body image interventions, particularly for older
      adolescents aged 15-17 years, as this is a peak time for the onset of adolescent body image
      concerns; however, currently there are no evidence-based body image programmes for this age
      group.

      This cluster randomised control trial will evaluate the effectiveness of BodyKind, a four
      session, teacher led, mixed gender body image intervention for older adolescents that
      incorporates empirically supported principles of self-compassion, cognitive dissonance and
      social justice. The version of BodyKind culturally adapted for the Irish context will be
      evaluated in adolescents aged 15-17 years in fourth year in post-primary schools in Ireland.
      Primary outcomes of body dissatisfaction, body appreciation and psychological wellbeing, in
      addition to secondary outcomes of body ideal internalisation, self-compassion and compassion
      for others will be assessed at pre, post and 2 month follow up in intervention groups (who
      receive the BodyKind programme) and waitlist controls.

Cluster Randomised Control Trial of the BodyKind Body Image Programme

Body Image

Design:

      This pragmatic trial will be conducted in settings similar to the "real world" which will
      include use of a school setting, teacher-led delivery during classroom time, no strict
      exclusion criteria for students and comparison to routine lessons-as-usual. Data collection
      time points will be selected to align with school academic calendars and will be conducted at
      pre, post and two month follow up. Schools will be randomly allocated to an intervention
      group (who receive the BodyKind programme) or a waitlist control. Participants in
      intervention and waitlist groups complete measures at the same timepoints, and those in the
      waitlist control will receive BodyKind after all assessments are completed. A mixed methods
      evaluation of implementation quality will also be conducted to understand 'why' programme
      outcomes were observed and inform efforts to optimise programme delivery in schools in the
      future.

      Randomization:

      Prior to randomization, schools will be stratified based on school categorization (e.g.,
      co-educational/ single sex girls/ single sex boys), size (i.e., estimated number of students
      in Transition Year available to participate) and location (i.e., urban/rural categorisation)
      to ensure the gender and geographical location of participants in each treatment group will
      be closely balanced. Shortlisted schools will be then randomly allocated to condition by the
      primary researcher using a computer-generated minimisation procedure. Minimisation is a
      method of randomisation that allocates participants to the treatment group that best
      maintains balance in prognostic factors (e.g., gender balance across condition). The first
      participant is allocated a treatment at random. Each subsequent participants' allocation is
      determined by what treatment allocation would lead to better balance between the groups in
      the variables of interest. Minimisation ensures excellent balance across treatment groups and
      is desirable when there are strong prognostic factors (e.g., gender) and modest treatment
      effects. Shortlisted* stratified schools will be allocated using covariate-constrained
      randomisation, a type of minimisation randomisation, for a two arm cluster randomized control
      trial, with the R statistical package cvcrand
      (https://cran.r-project.org/web/packages/cvcrand/cvcrand.pdf). Allocation of schools to
      experimental/waitlist treatment groups will be constrained by a.) the number of boys in TY in
      each school, b.) the number of girls in TY, and c.) the school's location categorisation
      (urban/rural). Schools that drop out will be replaced by schools on the waitlist based on
      minimisation or replacement by same category to same allocation (e.g., if an urban school
      drops out/fails to sign principal consent form they will be replaced by an urban school on
      the waitlist and to the allocation assigned to that urban school).

      Data collection procedures:

      Recruitment will occur at the school level. Schools will be recruited via emails (Educator
      School Centre's Ireland's mailing list and cold call invitations), teacher training events
      and advertisement on social media & website pages. Schools will be selected on the basis of
      (1) their expressed interest and (2) their fit with recruitment criteria.

      Shortlisted schools registering interest and meeting these criteria that decline to
      participate after initial contact will be replaced by the next school from the waitlist of
      eligible schools who registered interest with the researcher. Schools will receive a €200
      financial honorarium for participating.

      Sample size:

      The aim is to recruit 600 students aged 15-17 years in 4th year who attend second-level
      schools in Ireland. The aim is also to recruit 1-2 second-level teachers per school, from
      12-28 schools, to deliver the BodyKind programme to adolescents.

      Sample size rationale An RMASS power analysis (http://www.rmass.org/RMASS_Manual.pdf) based
      on parameters; small Cohen's d effect size of .2, power .80, alpha .05, indicates that 504
      students are required. To account for natural attrition and unanticipated events that reduce
      participant numbers (e.g., student absence due to illness) in RCTs, approximately 20% (n=100)
      more participants will be recruited giving a total N=600. A systematic review of consent
      procedures and participation rates reported that the average consent rate for active parental
      consent was 65.5% (range: 11-100%). The average number of students in TY in schools in
      Ireland is 140; therefore, allowing for a 65% response rate would indicate that a minimum of
      8 schools would be required to obtain a sample size of 600. However, a recent pilot trial of
      a self-compassion body image intervention in Ireland recruited an average of 25 TY students
      per school using opt in parental consent (4 schools, N=100), indicating that n=24 schools
      would be required to attain a sample size of 600. Given the variability in class size in
      Transition Year and range in consent rates for active parental consent the investigators will
      seek to recruit within this range until sample size of 600 is met. To guard against drop out
      at a cluster level the investigators will aim to oversample and recruit at least 12 schools
      and a maximum of 28 schools.

      Hypotheses:

      The hypotheses are

        1. Compared to participants in the waitlist control, participants who receive the BodyKind
           programme will experience statistically significant increases in a.) body appreciation,
           psychological wellbeing, self-compassion and compassion for others and b.) significant
           decreases in body dissatisfaction and body ideal internalisation from pre- to
           post-intervention.

        2. Changes will be maintained in experimental groups at a 2-month follow up.

        3. Changes in body appreciation and body dissatisfaction will be mediated by
           self-compassion, compassion for others and body ideal internalisation. No a-priori
           assumptions about the directionality of effects will be made.

        4. Changes in body appreciation, body dissatisfaction and psychological wellbeing will be
           moderated by appearance related social media use, appearance teasing, gender, baseline
           body appreciation, body dissatisfaction, psychological wellbeing and implementation
           quality. There are no a-priori assumptions about the directionality of effects.

        5. The programme will be considered acceptable and feasible by adolescents and teachers

        6. The programme can be implemented with high fidelity by teachers

      Data analysis plan:

      Prior to conducting inferential statistics, data will be screened for missingness, outliers,
      normality and model assumptions. Data will be summarised graphically and by using descriptive
      statistics.

      H1. Generalised linear mixed effects models (GLMM) will be used to determine change on
      outcome measures. Primary analysis will compare measures at time one (baseline) and two
      (post-intervention), to identify fixed effects of the intervention. Potential clustering
      effects will be examined and accounted for at the school level. The model will include 2 main
      effects (1. Repeated measures effect of time and 2. Between subjects effect of condition) and
      one two way interaction (time*condition). Gender effects will also be considered. With gender
      in the model will have three main effects and corresponding two-way and three-way
      interactions.

      H2. Secondary analyses will examine data from time 3 (follow-up) to see if the intervention
      condition has maintained hypothesised changes in dependent variables. Investigators will also
      assess the proportion of within-group and between-group variance by calculating the ICC. As
      complex models can fail to converge, if investigators encounter convergence issues in our
      models, investigators may consider dropping the random effect accounting for the smallest
      proportion of between-group variance. *Note: If the recruitment target (n=600) is not met, a
      different statistical analytic technique, 2 (condition; experimental, control) x 3 (time;
      pre, post, follow up) mixed factorial ANOVA will be used. This can detect small effects, but
      not clustering effects, in a sample size of 238 participants, according to a MorePower
      analysis. Post-hoc planned comparisons will be conducted using t-tests to examine changes
      within groups (intervention vs control) at different time points.

      H3. Mediation analyses will investigate whether changes in body ideal internalisation,
      self-compassion and compassion for others mediate change in body dissatisfaction and positive
      body image from T1 to T2.

      H4. Moderation analyses will investigate whether appearance related social media use,
      appearance teasing, gender, school type, baseline body appreciation, body dissatisfaction,
      psychological wellbeing and implementation quality moderate changes from T1 to T2.

      H5. Descriptive statistics will be used to assess teacher fidelity ratings

BodyKind programme

Effectiveness of the BodyKind School-based Body Image Intervention: a Cluster Randomised Control Trial

Body Appreciation Scale-2 is a 10-item scale. Responses to items such "I feel good in my body" are indicated on a 5-point Likert Scale (1-5), with higher scores indicating higher levels of body appreciation (Min-Max: 10-50). BAS-2 demonstrates good validity and reliability among international adolescent samples

Body Satisfaction Visual Analogue Scales Items from the appearance/weight subscales of the Eating Disorder Examination Questionnaire will be adapted as 10-point visual analogue scales (VAS) to assess state body satisfaction with various aspects of appearance. Participants will use a 10-point slider 0 (not at all satisfied) and 10 (very satisfied) to rate how satisfied they feel with their body shape, weight, and size. Participants will also rate their satisfaction with height, muscle mass/tone and overall appearance. A mean score from the six appearance dimensions will be calculated, with higher scores representing higher state body satisfaction. This approach has been shown to have good convergent validity with the Eating Disorder Inventory Body Dissatisfaction Subscale in adolescents (r = .62). Higher scores indicate higher body satisfaction. (Min-Max score: 6-60]

The Five-Item World Health Organisation Wellbeing Index is a unidimensional scale that measures emotional wellbeing using five positively worded items. Participants indicate the extent to which positive feelings, such as "I have felt calm and relaxed" were experienced over the last two weeks, using 6-point Likert scales ranging from 0 (not present) to 5 (constantly present). Raw scores are transformed to a score from 0 (worst thinkable well-being) to 100 (best thinkable well-being) with scores <50 suggesting poor emotional well-being.The WHO-5 has been validated for use with adolescents and has adequate validity as an outcome measure in clinical trials

The Self-Compassion Scale for Youth is a shortened and modified version of the Self-Compassion Scale developed for use with adolescent populations. The SCS-Y is a 14-item scale that contains subscales for the aspects of compassion; self-kindness, self-judgement, common humanity, isolation, mindfulness and over identification. Participants respond to items such as "When I feel frustrated or disappointed, I think about it over and over again." on 5-point Likert scales ranging from 1 (never) to 5 (always). Negatively worded items are reverse coded. Higher scores indicate higher levels of self-compassion [Min-Max scores: 14-70]. The SCS-Y has been validated among adolescents aged 12-17 years, where mean scores range between 1.0-2.49 (low), 2.5-3.5 (moderate), and 3.51-5.0 (high) and demonstrated good levels of internal consistency with Cronbach's alpha of >=.82 for each subscale.

Internalization-General subscale of the Sociocultural Attitudes Towards Appearance Scale-3 will be used to assess internalization of social media ideals. Items were adapted to social media by substituting the words "social media" into item stems e.g. "I would like my body to look like people on social media". The five-item scale is measured using five-point Likert scales ranging from 1 (definitely disagree) and 5 (definitely agree). Negatively worded items are reversed coded and items are averaged to yield a mean score, with higher scores indicating greater body ideal internalization (Min-Max Score: 5-25). The original scale has been shown to be a reliable in adolescent girls and boys and the adapted scale has been found demonstrate good psychometric properties and good levels of internal consistency, ranging from α = 0.75 among male, and α = 0.84 among female adolescents

The Appearance-Related Social Media Consciousness Scale is a 13-item scale that captures the extent to which individuals' thoughts and behaviours reflect ongoing awareness of whether they might look attractive to a social media audience. Given that appearance-related use is a more important predictor of body dissatisfaction compared with general/non-visual social media use, this measure is important to include. Items such as "I think about how specific parts of my body will look when people see my pictures on social media" are measured using 7-point Likert scales ranging from 1 (Never) to 7 (Always). Higher scores indicate higher levels of consciousness about appearance-related social media use (Min-Max score: 13-91) ASMC scores demonstrate strong internal consistency, convergent and incremental validity, and test-retest reliability in adolescent boys and girls

The Compassion Towards Others Action Subscale of the Compassionate Engagement and Action Scales Youth, measures compassion in adolescents. The 4-item action orientation competency subscale focuses specifically on actions aimed to prevent and alleviate distress/suffering in others, such as "When others are distressed or upset by things, I am kind and supportive to them". Participants respond using 10-point Likert scale from 0 (never) to 10 (always) with higher scores indicating higher compassionate action orientations towards others (Min-Max score: 0-40). This subscale shows good internal consistency with alpha values across items ranging between α=.84-.88 in adolescent boys and girls.

The intervention group will receive the BodyKind body image programme. The four 50 minute lessons of the BodyKind programme will be delivered by teachers at a rate of 1 lesson per week over four consecutive weeks.

The waitlist control group will engage in classes as usual and will receive the BodyKind programme after data is collected.

Cluster Randomised Control Trial of the BodyKind Body Image Programme

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status