Effectiveness of the BodyKind School-based Body Image Intervention: a Cluster Randomised Control Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- University College Dublin
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Body Appreciation
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Schools will be eligible if
- •they are a second-level school in Ireland that offers the Transition Year (TY) programme to students
- •will deliver the intervention as part of their curriculum to students in TY
- •teaching staff are willing to complete the 2.5-hour BodyKind teacher training programme.
- •Students will be eligible if
- •they are in TY in a second-level school in Ireland and are aged 15-17 years
- •If their parent consents to their participation AND if they provide a signed assent form .
- •Teachers will be eligible if
- •They are qualified secondary school teacher
- •They agree to complete the BodyKind teacher training
- •Return a signed informed consent form
Exclusion Criteria
- •Schools will be excluded if
- •they are not a second-level school in Ireland or if they do not offer the TY programme to students
- •will not deliver the intervention as part of their curriculum to students in TY
- •teaching staff are not willing to complete the 2.5-hour BodyKind teacher training programme.
- •Students will be excluded if
- •they are not in TY in a second-level school and are not aged 15-17 years
- •If parental consent has not been obtained OR if they fail to sign a participant assent .
- •Teachers will be excluded if
- •They are not qualified secondary school teacher
- •They do not agree to complete the BodyKind teacher training
- •Do not return a signed informed consent form
Outcomes
Primary Outcomes
Body Appreciation
Time Frame: 1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up
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 Dissatisfaction
Time Frame: 1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up
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\]
Psychological wellbeing
Time Frame: 1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up
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
Secondary Outcomes
- Self-compassion(1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up)
- Appearance related social media use(1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up)
- Body ideal internalization(1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up)
- Compassion towards others(1 week pre-intervention, 1 week post-intervention, 2 month post intervention follow up)