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The co-creation, initial piloting, and protocol for a cluster randomised controlled trial of a coach-led positive body image intervention for girls in sport

BMC Public Health volume 23, Article number: 1467 (2023) Cite this article

Abstract

Background

Globally, girls disengage from sports at an earlier age and higher rate than boys. This is, in part, due to the unique body image challenges that girls face, relative to their male peers. Existing intervention efforts that aim to reduce girls’ negative body image and movement experiences have proven marginally effective, if not ineffective. This paper outlines the co-creation, initial piloting and protocol for a cluster randomised controlled trial of Body Confident Athletes (BCA); an in-person, coach-led intervention that aims to foster positive body image and sports enjoyment among girls.

Methods

Following co-creation and an initial pilot, a two-armed cluster randomised controlled trial will assess the immediate (post-intervention) and short-term (1-month and 3-month follow-up) impact of BCA on girls’ (N = 1,036; 11–17 years old) body image, sports enjoyment, and affect. Sport organisations will be randomly allocated (1:1) into either an intervention or waitlist control condition. Girls and coaches in the intervention condition will complete three 60-minute sessions over three consecutive weeks. The primary outcome will be the immediate change in girls’ body esteem, with secondary outcomes assessing the immediate and short-term changes in girls’ body appreciation, self-objectification, attuned self-care, sports enjoyment, and affect.

Discussion

This research is the first to utilise an international multi-stakeholder partnership to co-create and evaluate an intervention that addresses the intersection of girls’ body image and sport experiences. The theoretical and methodological considerations of this research have led to a feasible intervention and trial protocol, and if proven effective, BCA may assist in reducing the global gender disparity in sports participation.

Trial registration number

NCT05594524, registered 25th October 2022.

Peer Review reports

Background

Globally, girls disengage and drop out of sport at a significantly earlier age and higher rate than boys [1]. Numerous biopsychosocial factors have been found to spur these rates, many of which intersect with body image [2]. Body image is broadly defined as the way an individual thinks, feels and behaves towards their body, including its appearance and how it functions. Girls’ body image in sports is influenced by biological (e.g., puberty), psychological (e.g., comparison making), and social (e.g., gender stereotypes, appearance and athletic ideals, appearance-based teasing) factors that are both universal (e.g., puberty, comparison making, appearance-teasing) and context-specific (e.g., gender stereotypes, athletic ideals) [2]. During puberty, girls experience rapid physical changes (i.e., larger breasts, wider hips, weight gain) that are both commodified and criticised by the sports community, and by society more broadly [3, 4]. Specifically, female bodies are over-evaluated and objectified through revealing sports attire, appearance-oriented media coverage and harassment from male peers; simultaneously, girls’ maturing bodies can be perceived as problematic and disadvantageous to sports (e.g., the perception that developed and larger bodies are associated with poorer performance [5, 6]). As a result, many girls are encouraged by socio-cultural agents (e.g., peers, coaches, and the media) to under fuel and over train their bodies to suppress the natural development of the female body [7]. Subsequently, a growing number of girls disengage from sports due, in part, to this undue pressure, and those who remain are at increased risk of developing body dissatisfaction, disordered eating, and/or an eating disorder, particularly those participating in appearance- (e.g., gymnastics, figure skating) or weight-sensitive sports (e.g., cross-country, rowing) [6, 8,9,10,11].

Targeting the intersection of girls’ body image and movement experiences

To date, numerous interventions have sought to address the intersection between girls’ body image and movement experiences (i.e., physical activity, exercise, and sport), as a means for reducing gender disparities in movement participation; however, in a recent systematic review and meta-analysis these approaches were marginally effective, if not ineffective. This is, in part, due to theoretical and methodological limitations within and across the 12 studies pertaining to girls. For instance, a majority of interventions utilise a risk reduction framework, whereby the primary aim is to reduce girls’ body dissatisfaction through increased movement (e.g., aerobic dance class). In only focusing on, and alleviating, body dissatisfaction, girls, at best, develop a neutral relationship with their bodies (e.g., “I neither like or dislike my body while dancing”), rather than a deeper acceptance, appreciation, and respect for what their body can do and experience while participating in sport (e.g., “I’m grateful for my legs. They propel me in the air when I’m dancing”; “I’m thankful that my body can heal itself from injury”) [12]. This latter perspective reflects positive body image and embodiment theories [13,14,15], which offer a more nuanced and holistic view of one’s relationship with their body, beyond simply being satisfied with how it looks.

To our knowledge, only one intervention has explicitly utilised positive body image and embodiment principles to address the intersection of girls’ body image and movement experiences (Healthy Body Image [HBI]; [16]). Specifically, HBI comprises three 90-min workshops, which address negative and positive body image (workshop one), media literacy (workshop two), and healthy lifestyles (workshop three). Evaluations of HBI in Norwegian high schools (N = 2,446 girls (57%) and boys; Mage = 16 years) [17, 18], found improvements in girls’ positive body image [17], but not their movement levels [18]. Collectively, these findings indicate that HBI is an effective positive body image intervention for adolescent girls; however, it may be ineffective at addressing the intersection between girls’ body image and movement. This is likely due to a disconnect between intervention content and movement contexts. That is, the intervention techniques address general positive body image concepts (e.g., How can changing from an aesthetic to a functional focus improve body experiences and healthy lifestyles?), rather than relating and applying these concepts to movement contexts and experiences (e.g., What is my body able to do and experience when playing sport, and why is this important?). To our knowledge, an intervention of this nature has yet to be developed.

Co-creation and task shifting intervention delivery

Another key limitation of existing interventions is the lack of community-based participatory research (CBPR) principles and practices incorporated into the development and/or selection of an intervention [19]. For example, to our knowledge, a majority of existing studies in this space did not consult with key stakeholders who would be involved in, or impacted by, the intervention during community dissemination and implementation (e.g., girls, coaches, sport organisations, and community or industry partners). This oversight has implications for intervention feasibility, including its acceptability, implementation, integration, and efficacy [20]. The use of CBPR is recognised as a key element of effective intervention development and is mandatory in some peer-reviewed communities (e.g., journal submission requirements). Relatedly, a majority of the abovementioned studies used exercise, body image, and/or mental health specialists to deliver the intervention to girls. Reliance on specialists for dissemination and implementation also has implications for intervention feasibility and scalability [21]. Task shifting to non-specialists has proven effective, but without some of the financial and human resource costs accompanied with the use of specialists [21].

Additional advantages of task shifting intervention delivery to non-specialists and, more specifically, to influential members within sport communities, for instances coaches, include: 1) coaches have an existing relationship with girls, and are likely to have good group management skills and a passion for supporting young people; 2) coaches become skilled with the knowledge and strategies to effectively and sustainably deliver a body image intervention within sport contexts; 3) coaches are influential members within their communities, and once trained, could use their newly acquired knowledge and strategies to influence other system-levels within these communities (e.g., policy change for girls’ sport); and 4) coaching is a transient profession, which requires travel to, and interacting with, other sport communities (e.g., tournaments, professional development), which might allow for further dissemination of core learnings and messages. Therefore, developing a feasible intervention that coaches like and find easy to disseminate and implement within their communities will increase their likelihood of sharing this resource with other coaches and athletes who would benefit.

The present paper

This paper outlines the co-creation, initial piloting and protocol for a cluster randomised controlled trial of Body Confident Athletes (BCA); an in-person coach-led intervention that aims to increase girls’ positive body image and sports enjoyment. The co-creation of this intervention was guided by the framework for developing complex interventions (see Table 1; 23,24), with the procedures for the pilot and the cluster randomised controlled trial informed by the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT; see Table 2), the Consolidated Standards of Reporting Trials (CONSORT; [22]), and the extension to cluster randomised trials (CONSORT; [23]). The SPIRIT and CONSORT checklists are provided in the Supplementary materials.

Table 1 Guide for developing complex interventions – key steps and considerations
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Table 2 Schedule of enrolment, interventions, and assessments according to the Standard Protocol Items: Recommendations for Interventional Trials
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Findings from the co-creation (see section Cluster randomised controlled (Pilot) trial) and initial pilot (see section Co-creating the intervention) informed the final protocol for the cluster randomised controlled trial (Fig. 1), which will compare BCA to a waitlist control condition (i.e., participate in sport as usual). This is a pragmatic trial conducted in settings similar to the “real world” (i.e., adopts a sport setting, coach-led delivery, delivered during typical sport practice, no strict inclusion or exclusion criteria for athletes, comparison to usual sports participation) [28]. Participants in the intervention condition will complete three 60-minute sessions over three consecutive weeks. At completion of the final follow-up survey, girls and coaches in the control condition will participate in the intervention; however, their participation will not be monitored or evaluated.

Fig. 1
figure 1

The main trial research design according to the Consolidated Standards of Reporting Trials (CONSORT)

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Assessment of primary (body esteem) and secondary (body appreciation, self-objectification, attuned self-care, sports enjoyment, and affect) outcomes will be conducted at baseline (T1), post-intervention (T2), 1-month follow-up (T3), and 3-month follow-up (T4). Fidelity assessments will be conducted on both coaches’ delivery of the intervention, as well as girls’ comprehension of the intervention content. It is hypothesised that girls randomised into the intervention condition will experience greater improvements in body image (body esteem, body appreciation, attuned self-care, resisting objectification), sports enjoyment, and positive and negative affect at post-intervention, 1-month, and 3-month follow-up, relative to the waitlist control condition.

Method

Community-Based Participatory Research (CBPR)

This research adopted the CBPR principles as outlined by Collins and colleagues [19], who describe this framework as an inclusive and flexible approach to equitably involving key stakeholders in research. First and foremost, an international multi-stakeholder partnership was formed and maintained between girls, coaches, academics, and community and industry partners throughout the entirety of this research. Second, the target audience (i.e., girls), as well as those impacted by the new intervention (i.e., coaches) were consulted on throughout this research. For instance, initially, we consulted with girls (n = 91) on their experience of the said issue (e.g., body image concerns in sport), along with their preferences for how to address these concerns in a new intervention. Details and findings from this research phase are reported elsewhere [29]. From here, an initial intervention prototype was developed, whereby a smaller group of girls (n = 10) and coaches (n = 4) were invited to provide feedback on the intervention content, structure, and format. Next, a separate group of girls (n = 26) and coaches (n = 7) participated in a pilot study in the US (see section Cluster randomised controlled (Pilot) trial), which assessed the intervention feasibility, including acceptability, implementation, integration, and limited efficacy testing [20], as well as the feasibility of conducting a two-armed, cluster randomised controlled trial. Girls and coaches participating in these two phases were recruited via a sport organisation, Laureus Sport for Good.

Co-creating the intervention

A combination approach to intervention development was utilised [30, 31], whereby the existing evidence base on girls’ body image, sports, and mental health and well-being were coupled with CBPR to inform intervention content, structure, format, dissemination, and implementation. The key steps associated with this approach are reported in Table 1. To increase intervention scalability, this research adopted a cross-national lens from the outset and intersected with all elements of the research, including an initial systematic review and meta-analysis (e.g., considering existing interventions from all countries), stakeholder input (e.g., consultation with girls from 13 countries [29]), and intervention materials (e.g., development of a localisation toolkit for intervention adaptation and localisation for different countries).

The intervention content (e.g., session topics and activities) targets both risk and protective factors for body image. Topics and activities were taken from existing evidence-based body image interventions and then adapted for, and applied to, sport-specific settings and scenarios. Meanwhile, the intervention structure (i.e., four key sections within each session) and format (i.e., five 60-min sessions) were informed by previous reviews into the optimum intervention features for addressing body image and/or movement among adolescent girls [32,33,34,35]. A summary of the intervention sessions, and the associated theories, learning objectives, and learning experiences are reported in Table 3.

Table 3 Body confident athletes intervention sessions, underpinning theories, learning objectives, and learning experiences
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The intervention materials comprised of: 1) a coaches’ session guide that provides step-by-step instructions on how to deliver each session; 2) 3 × 5-min coaches’ training videos that contextualise body image in sport and strategies for how to deliver the programme effectively; 3) a presentation deck containing visual stimuli that aims to facilitate discussions during the sessions; and 4) an athletes’ workbook where girls can privately respond to questions and discussions addressed in the sessions. A screenshot of the materials is provided in Fig. 2.

Fig. 2
figure 2

Screenshots of the Body Confident Athletes materials including the coaches’ session guide (a), presentation deck (b), and athletes’ workbook (c)

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Lastly, a localisation toolkit will sit alongside the intervention materials, and will support dissemination partners on how to adapt and localise content such that it is culturally relevant. For instance, using examples of local and national sports women; acknowledging cultural norms that impact girls’ body image and sports participation (e.g., parents not allowing girls to wear sports attire in India); being aware of and sensitive to religious beliefs and practices and how this impacts girls sport experiences. This content was informed by the initial consultation with girls and the cross-national considerations they raised [29].

Cluster randomised controlled (Pilot) trial

Pilot procedure

The pilot was, and the main trial will be, conducted in the US. This was a collaborative decision made by the multi-stakeholder partnership group; a decision that was informed by existing connections and resources of the partnership, which would increase the feasibility of conducting the trial within the intended timeline. The aim of the pilot was to test the preliminary feasibility of the intervention (acceptability, implementation, integration, and limited efficacy) [20], as well as the feasibility of conducting a two-armed, cluster randomised controlled trial in the US. The pilot trial was held between May–October 2022 (May–July = recruitment; August–October = data collection), with findings informing the final version of the intervention that would be trialled (i.e., content, structure, and format), as well as the protocol for the main trial.

Initially, organisations were randomised into either the intervention or waitlist control condition. Following this, girls and coaches in both conditions completed a baseline assessment containing self-report measures of demographics (i.e., age, ethnicity, coaching experience or playing experience). Girls also completed self-report measures of trait body image (primary outcome; [38]) and sports enjoyment (secondary outcome; [39]), which informed preliminary efficacy. Next, those in the intervention condition completed five 60-minute sessions over five consecutive weeks. At post-intervention, girls in both conditions but only coaches in the intervention condition completed a second survey. All girls completed post-intervention assessments of trait body image and sports enjoyment, and girls and coaches in the intervention condition completed assessments on intervention acceptability (13 items; e.g., The programme covered topics that are important to my athletes [coaches]; I would recommend the Body Confident Athletes programme to other girls [girls]), with coaches also providing assessments on intervention structure and integration (7 items; e.g., Our club or school could sustainably continue offering this programme to girls [e.g., to newcomers; in our outreach programmes]).

Intervention fidelity was also assessed via session recordings. Specifically, coaches were scored on the accuracy with which they delivered the intervention sessions, and girls’ responses were assessed for relatedness to the key learning objectives in The Knowledge and The Skills sections of the sessions. At completion of the post-intervention assessments, girls and coaches in the control condition were provided with the intervention materials; however, their participation was not evaluated. To compensate participants for their time, girls and coaches received an electronic voucher to the value of US$60.

Pilot findings

Initially, eight organisations were recruited for participation in the pilot trial, with four organisations dropping out at baseline (i.e., due to staff turnover or scheduling clashes). Girls and coaches from four organisations saw the pilot to completion, including completing baseline and post-intervention assessments, and completing five 60-minute sessions over five consecutive weeks (see supplementary Fig. 1 for design and participant flow). A total of 26 girls participated in the pilot (Mage = 12.73 [SD = 1.99]; n = 13 in intervention; n = 13 in control). Nineteen girls completed baseline assessments (n = 10 in intervention; n = 9 in control), with 12 providing post-intervention data (n = 7 in intervention; n = 5 in control). A majority of girls identified as White (34.61%, n = 9), followed by 23.07% (n = 6) as Hispanic, 19.23% (n = 5) as Black, 11.54% (n = 3) as Asian, 7.69% (n = 2) as multi-racial, and one preferred not to say. Participants had been a member of their sport organisation for an average of 3.38 years (SD = 1.52). Girls in the two arms did not significantly differ on any of the demographic variables. A total of seven female coaches (Mage = 29.71 [0.92]; n = 4 in intervention; n = 3 in control) participated in the pilot. All coaches completed baseline assessments; however, only three coaches from the intervention condition provided post-intervention data. Three coaches were Black (42.85%), three were White (42.85%), and one was multi-racial (14.28%). Coaches had been a member of their sport organisation for an average of 3.00 years (SD = 1.40). Coaches in the two arms did not significantly differ on any of the demographic variables.

With respect to intervention fidelity (i.e., was the intervention delivered as intended), a random subset of sessions was autonomously assessed by two raters to check for inter-rater reliability. The remaining sessions were equally split and assessed by only one rater. We calculated Cohen’s κ as a measure of agreement for all the categorical items (Yes/No items for coaches’ fidelity assessment on each section of the sessions; The Game Plan, The Knowledge, The Skills, The Final Score) and ICC for all the ordinal items (0–100 items for athlete’s fidelity assessment on The Knowledge and The Skills). Overall, Cohen’s κ was 0.79 (z = 7.15, p-value < 0.001), indicating substantial agreement between raters. Similarly, the ICC was 0.88 (F(7,8) = 15.30, p < 0.001), suggesting excellent between-raters reliability. Overall, coaches scored 75.35% on fidelity of intervention delivery. Specifically, coaches scored 95.83% on The Game Plan section, 67.06% on The Knowledge section, 70.83% on The Skills section, and 67.70% on The Final Score section. These scores are comparable to other multi-session body image interventions delivered by non-specialists [40, 41]. Girls also demonstrated a high level of intervention comprehension, with an overall score of 88.68%. Specifically, girls scored 91.66% on The Knowledge section and 85.71% on The Skills section. With respect to intervention adherence, of the 13 girls initially randomised to the intervention, seven girls attended Session 1 and 2 (53.84%), four attended Session 3 (30.77%), three attended Session 4 (23.07%), and six attended Session 5 (43.15%). Overall, two athletes (15.38%) attended all five sessions.

With respect to intervention acceptability and integration, coaches scored both the intervention materials and topics (M = 4.21 out of 5 [SD = 0.87]) and the potential integration of the intervention highly (M = 4.00 out of 5 [SD = 0.62]). Similarly, athletes reacted positively to the intervention (M = 4.18 out of 5 [SD = 0.38]). Qualitative feedback from girls and coaches was also obtained. Due to the small sample of responses, formal qualitative analyses were not conducted. Overall, girls and coaches felt the intervention created a space for girls to discuss important and relevant topics. Key areas for improvement included greater accessibility and representation of girls with Physical Disabilities who play sport, and a printer friendly version of the coaches’ session guide.

With respect to preliminary efficacy, due to attrition rates (i.e., 50% at baseline), an insufficient sample size was obtained to determine the intervention’s efficacy at improving girls’ body image and sports enjoyment. However, exploratory analyses were conducted on the mean scores of the primary and secondary outcomes, and the changes in mean scores were in the intended direction. That is, girls in the intervention condition reported improvements in body image and sports enjoyment, relative to the control condition who reported declines. A summary of these scores is reported in the Supplementary materials.

Based on the above findings, as well as consultation with stakeholders (i.e., girls, coaches, and community and industry partners), several modifications were made to the content and structure of BCA, which were deemed to increase intervention feasibility. This included reducing the number of sessions from five to three. That is, a three-session intervention was deemed more conducive to sport schedules and therefore would increase intervention adherence. Based on the intervention theory and aims (see Table 3), sessions one (Gender Stereotypes in Sport) and five (Advocacy in Sport) were removed, as these were considered more distal to girls’ body image and sports enjoyment, relative to the topics covered in the remaining three sessions. Further, the intervention content was reviewed for greater accessibility and inclusivity, particularly for girls with Physical Disabilities. Specifically, a Disability educator and activist with lived experience reviewed the intervention language and imagery, and changes were made to increase representation of girls with Physical Disabilities (e.g., adding examples into the intervention content that reflect their sport experience). Of note, this intervention is not yet suitable for all types of Disabilities (e.g., Deaf-Blindness; Hearing Impairments; Intellectual Disabilities, etc.), and therefore further adaptation and modifications are required before testing the intervention among girls living with these Disabilities.

With respect to the feasibility of conducting a two-armed, cluster randomised controlled trial in the US, the pilot highlighted several key limitations of the protocol, which required remedying before the main trial. First, the recruitment and onboarding period was lengthened from 3 to 6 months. This was based on feedback from coaches and their organisations that more time was needed to: 1) understand the research requirements; 2) get executive approval (if necessary) from the head of their organisation; 3) identify eligible participants; and 4) schedule the research tasks (i.e., surveys and intervention delivery). Further, due to the seasonal nature of some sports (i.e., soccer, lacrosse), this process became more complex for coaches, and therefore additional time was needed for troubleshooting. This modification aims to improve the onboarding of organisations, coaches, and girls, and subsequently reduce the attrition rates observed at baseline. Second, eligibility criteria were expanded to include school sports. Initially, only sport-based youth development organisations were targeted, as initial dissemination and implementation efforts were aimed at organisations that are typically underserved; however, due to the global COVID-19 pandemic, numerous organisations were experiencing funding and staffing cuts and therefore could not dedicate the time and resources to research participation. Therefore, the main trial is open to school athletic departments alongside youth development organisations, with the continued aim of targeting schools in underserved communities.

Cluster randomised controlled (main) trial

Eligibility criteria

The current intervention has been developed for universal samples [42], in that it aims to provide population-wide benefits, irrespective of an individual’s level of risk or other relevant factors (e.g., type of sport, competition level). Therefore, increased risk for body image concerns or sports dropout are not inclusion criteria for this trial. Eligible participants will be girls aged 11–17 years old who play sport, English speaking, and US residents. Eligibility criteria will allow for different sport types (e.g., individual, team, aesthetic, non-aesthetic) and competition level (e.g., recreational, competitive). Coaches will be eligible to deliver the intervention, provided they currently occupy a coaching role (e.g., a coach at a school or sport recreational centre) and have a stable and ongoing relationship with the girls who will receive the intervention. Coaches and/or the organisations delivering the intervention will need to be available during both “Block A” (intervention condition) and “Block B” (waitlist control), with condition allocation masked from participants.

Measures

Research measures are presented in Table 4. One measure was purpose-built for the current research (i.e., girls’ comprehension of the intervention content). The remaining measures have been validated and widely used among adolescent girls, particularly in the US.

Table 4 Research outcomes and internal consistencies
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Participant recruitment and procedure

A community sample of a minimum of 1,036 girls aged 11–17 years from diverse ethnic, geographic, and socio-economic backgrounds will be recruited for the main trial via a US recruitment partner who specialises in health education in school and community settings. Recruitment will occur in the 6 months prior to the trial start date (i.e., September 2022–February 2023) and will involve the following steps: 1) circulation of an online survey containing study information and an expression of interest and screening questionnaire (e.g., Do you coach girls between 11–17 years old?; What is the estimated number of girls between 11–17 years that you will be coaching between February–July 2023?) via the recruitment partner’s social media platforms and emailing lists; 2) following screening, eligible coaches and/or organisations will be invited to an information session held by the recruitment partner, where attendees will received a more detailed overview of the intervention and research tasks; and 3) provided coaches and/or organisations feel comfortable with, and confident that they can achieve, the research tasks, they will schedule an onboarding call with the third author (AT).

Following the onboarding process, organisations will be randomised into either the intervention (Block A) or waitlist control (Block B) condition (see Fig. 1 for participant flow). Those assigned to Block A will be advised to schedule the intervention between the 6th February and 2nd April 2023, while those assigned to Block B will be advised to schedule their delivery after the 2nd July 2023. Three weeks prior to intervention delivery, coaches and parents will complete informed consent via an online survey. Following parental consent, girls in both conditions will complete informed assent and baseline assessments of primary and secondary outcomes via an online survey one week prior to intervention delivery. Girls will be encouraged to complete the surveys in the privacy of their homes; however, coaches agreed to make surveys accessible immediately before session one (e.g., girls will attend 20 min early and complete via a mobile device), should girls have difficulty completing the survey on their own accord. The intervention will be delivered in the team’s usual practice space, with logistics regarding equipment and space accessibility coordinated and confirmed with coaches during the onboarding call with the research team. At the end of the intervention period (i.e., 3 weeks), both conditions will be assessed on primary and secondary outcomes, and again at 1-month and 3-month follow-up. Following the final assessment, the waitlist control group will complete the intervention; however, their engagement will not be monitored or assessed. Lastly, to compensate participants for their time, they will receive an electronic voucher, with girls receiving US$60, coaches receiving $100, and organisations receiving $200.

Randomisation and blinding

Randomisation will occur at the group level (1:1). The randomisation sequence will be generated using a computer software, with clusters randomised into the intervention or control condition. Randomisation will be conducted by an experienced researcher who is external to the authoring research team and the conditions will be masked. Throughout the recruitment and onboarding processes, group allocation will be masked to participants. The intervention group will be referred to as Block A and the control condition referred to as Block B. Coaches and/or organisations delivering the intervention will be advised that two scheduling blocks have been created due to the magnitude of participants. Study hypotheses will also be masked from participants. Lastly, data analysts will be unaware of condition allocation (dummy coded) when conducting statistical analyses on primary and secondary outcomes.

Data monitoring and management

Based on previous evaluations of body image interventions among young people [40, 41], this intervention and trial protocol are deemed low risk for participant safety and therefore an independent data monitoring committee was not established. However, the research team will monitor survey responses for data quality, including completeness, consistency, and plausibility. All survey data, including informed consent and self-report measures, will be downloaded from a university approved survey software (Qualtrics), and securely stored in a password protected data file on a university approved cloud storage (i.e., OneDrive). At the start of each survey (e.g., T1, T2, T3, T4), participants will create a unique identification code, which will allow responses to be matched across time points. Personal data (i.e., name, geographical location, email address) of coaches, parents, and girls will be stored separately to survey data (i.e., outcome measures), with both datafiles securely stored in a password protected datafile on the university cloud storage. Personal data will be deleted once the trial is complete. Audio recordings will be used to assess intervention fidelity and will be securely stored on the university cloud server. Once the fidelity inter-rater reliability assessments are complete, these recordings will be permanently deleted. Anonymised survey data will be made available on reasonable request for non-commercial purposes.

Statistical power

A meta-analysis of 31 studies evaluating interventions that target the intersection of body image and movement experiences among girls and women via randomised controlled trials reported a mean effect size of Cohen’s d = 0.18 on body image, which can be interpreted as a small-to-medium effect size. Based on conservative d = 0.2, an ICC of 0.02 within intervention delivery groups (as informed by a similar cluster trial of a body image intervention Craddock, Budhraja, Garbett, Nasution, Gentili, Rizkiah, Saraswati, Medise, White, Diedrichs & Williamson: Randomised Control Trial of Dove Confident Me Indonesia: Single Session. Forthcoming]), and an approximate distribution of 15 athletes per delivery group, a total sample size of 864 athletes (N = 432 per arm) would provide 90% power over a correlation between baseline and outcome data at T2 or about 0.6, considering alpha = 0.05. We will oversample to mitigate the effects of loss at post-intervention due to athletes’ absence or any other logistical difficulty. Therefore, the ideal sample size will be increased by 20%, leading to a minimum target of approximately 1,036 athletes (518 per randomised arm).

Data analyses

Data preparation, assessment of baseline equivalence, hypothesis testing, and exploration will be undertaken using SPSS 28.0 (IBM Corp, 2021) and R Studio (R Core Team, 2021). Data will be screened to ensure scoring fidelity and data accuracy. Once the data validity checks are complete, scales’ scores will be calculated, score distributions will be assessed, and the data will be checked for outliers and any inaccurate influential observations. Missing data will be assessed across all outcomes and time points. Data will be analysed on an intention-to-treat basis and secondly using data from participants with at least 70% of the attention checks successful completed.

The primary analyses will be linear mixed models with random intercepts for all outcome measures (body esteem, body appreciation, self-objectification, attuned self-care, sports enjoyment, and affect). The models will include two main effects: study phase (i.e., repeated measures fixed effect factor with three levels: T2, T3, and T4), randomised arm (i.e., between-subjects fixed effect factor with two levels: intervention and control), as well as baseline levels of the outcome as a covariate. The model will also see two two-way interactions (i.e., randomised arm by study phase, randomised arm by baseline). Analyses will be run on an intention-to-treat basis, both with and without clusters including a random effect (i.e., intervention delivery group), in order to identify their potential significant impact [54].

For each outcome measure, a priori ANCOVAs will compare the two randomised arms at T2, controlling for baseline measures as covariates. These analyses will be repeated at T3 and T4. If the homogeneity of regression lines assumption is violated, the ANCOVA model will include a baseline by randomised arm interaction. Exploratory moderation and mediation analyses will be run to check whether any differences in intervention efficacy might be dependent on relevant demographic or baseline variables. To ensure valid statistical inferences, we will check for any potential assumption violation in all the models.

Ethical issues, approval, and trial registration

This research adheres to the ethical standards and guidelines put forth by the University of Minnesota and the University of the West of England. Specifically, participants will receive an overview of project aims, objectives, and research tasks prior to providing consent. Further, participation is voluntary, and participants may withdraw at any stage without justification or penalty. Irrespective of their completion stage, all participants will receive a debrief form that discloses the research aims, along with additional mental health resources (e.g., evidence-base websites, helpline contact details). Any serious adverse events will be reported to the universities’ ethics committees. This study was reviewed by and received approval from the ethics committees at the University of Minnesota (STUDY00012457) and the University of the West of England (HAS.21.03.120c). The study is registered with Clinical Trials.Gov (https://www.clinicaltrials.gov/ct2/show/NCT05594524).

Dissemination

In accordance with the broader aims of this research, which are grounded in CBPR principles, findings from this research will be widely disseminated beyond the academic setting (e.g., peer-reviewed publication and academic conferences). Research findings, as well as the intervention materials will be hosted on a freely accessible website, as well as promoted via promotional campaigns. If BCA proves effective, it will be scaled up and delivered to young people across the US and other English-speaking countries, with future plans including the translation and localisation of the programme for non-English speaking countries (e.g., France, India, Mexico).

Discussion

This protocol reports on the co-creation, piloting, and planned cluster randomised controlled trial of a new intervention, Body Confident Athletes (BCA). This coach-led intervention aims to increase girls’ positive body image and sports enjoyment. An initial pilot assessed intervention feasibility, as well as the feasibility of conducting a two-armed cluster randomised controlled trial in the US. Findings from the pilot led to modifications to the intervention content (i.e., greater representation of girls with Disabilities in sport) and structure (i.e., reduced the core sessions from five to three), as well as modifications to the trial protocol (i.e., expanding the eligibility criteria and recruitment channels to include school athletic departments). Based on these amendments, the intervention and trials were deemed feasible with the main trial commencing 30 January 2023 (i.e., first wave of baseline assessments) and recruitment finishing 22 February 2023 (i.e., last opportunity to enrol). The main trial will assess the immediate (post-intervention) and short-term (1-month, 3-month) impact of BCA on girls’ body image (body esteem, body appreciation, attuned self-care, resisting objectification), sports enjoyment, and affect (positive and negative). At the completion of the trial, provided BCA is effective and does not require major revisions (e.g., is found ineffective or harmful), the intervention materials will be made freely available via an English website in October 2023.

This research makes several advancements in addressing the intersection of girls’ body image and sport experiences. To our knowledge, this is the first intervention on this topic to: 1) utilise a global and cross-national lens and community-based participatory research (CBPR) throughout the intervention development process; 2) target both risk and protective factors for body image and apply intervention techniques to sport-specific settings and scenarios; and 3) task shift intervention delivery to coaches. Relatedly, and to our knowledge, it is the first study on this topic to pilot test the feasibility of both the intervention and trial protocol prior to moving into a large-scale cluster randomised controlled trial. Collectively, these theoretical and methodological considerations allowed us to incrementally refine both the intervention (i.e., content, structure, and format) and the trial protocol (i.e., eligibility criteria and recruitment pathways). In turn, the main trial will be conducted on the most feasible intervention and under the most feasible conditions. If proven effective at enhancing girls’ positive body image and sports enjoyment in the US, BCA will be tested for effectiveness in other countries and cultures. Overall, these research efforts seek to increase BCA’s potential at improving girls’ positive body image and sports enjoyment across the world, which may possibly help with reducing genders disparities in sports participation.

Availability of data and materials

The intervention, Body Confident Athletes, will be freely available via a website that will be launched in October 2023. The datasets generated and/or analysed during the current study are not publicly available as per the data management and monitoring guidelines of the governing universities but are available from the corresponding author on reasonable request.

Abbreviations

AE:

Appearance Esteem

BCA:

Body Confident Athletes

CBPR:

Community-Based Participatory Research

CONSORT:

Consolidated Standards of Reporting Trials of Electronic Health

HBI:

Healthy Body Image

SPIRIT:

Standard Protocol Items: Recommendations for Interventional Trials

T1, T2, T3, T4:

Time One, Time Two, Time Three, Time Four

UK:

United Kingdom

US:

United States

WE:

Weight Esteem

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Acknowledgements

We want to thank Mahira Budhraja for conducting fidelity analyses; Harriet Smith and Sharon Haywood for their roles in the randomisation process; and the girls and coaches who participated in the various stages of intervention development, without whom this work would not be possible.

Funding

This study was funded by a research grant from the Dove Self-Esteem Project (Unilever; RHSS0180) and Nike (ref no. CON000000089960). The funders had no role in data analysis, decision to publish, or manuscript preparation. The Dove Self-Esteem Project (Unilever) and Nike Inc were permitted to review the manuscript and suggest changes, but the authors exclusively retained the final decision on content. The views expressed are those of the authors and not necessarily those of Unilever or Nike.

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Authors and Affiliations

  1. Centre for Appearance Research, School of Social Sciences, College of Health, Science and Society, University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK

    E. L. Matheson, J. Schneider, A. Tinoco, C. Gentili, P. White & P. C. Diedrichs

  2. Department of Sport, Exercise, and Performance Psychology, West Virginia University, Morgantown, WV, 26506, USA

    H. Silva-Breen

  3. Tucker Center for Research on Girls & Women in Sport, University of Minnesota, 1900 University Avenue SE, Minneapolis, MN, 55455, USA

    N. M. LaVoi

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  1. E. L. Matheson
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  4. C. Gentili
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Contributions

All authors have approved the manuscript and agree with its submission to BMC Public Health. Authors’ contributions are categorised as per the CRediT (Contributor Roles Taxonomy) guidelines. ELM: Conceptualisation; Methodology; Investigation; Resources; Writing – Original Draft; Writing – Review and Editing; Visualisation; Supervision (lead); Project Administration; Funding Acquisition. JS: Conceptualisation; Methodology; Investigation; Writing – Review & Editing; Project Administration. AT: Conceptualisation; Methodology; Formal Analysis; Writing – Review & Editing; Project Administration. HSB: Conceptualisation; Methodology; Writing – Review & Editing; Project Administration. CG: Conceptualisation; Formal Analysis; Writing – Original Draft; Writing – Review and Editing; Visualisation. PW: Formal Analysis; Supervision. NML: Conceptualisation; Methodology; Writing – Review and Editing; Supervision; Funding Acquisition. PCD: Conceptualisation; Methodology; Writing – Review and Editing; Supervision; Funding Acquisition.

Corresponding author

Correspondence to E. L. Matheson.

Ethics declarations

Ethics approval and consent to participate

The research will be conducted in accordance with the ethical standards and guidelines for conducting research with young people in the US. This study was reviewed by and received approval from the ethics committees at the University of Minnesota (STUDY00012457) and the University of the West of England (HAS.21.03.120c). Informed parental and participant consent will be obtained prior to participation. Participation is voluntary and participant withdrawal is possible at any stage of the research without justification. The intervention, Body Confident Athletes, and research findings will be disseminated via open access peer-reviewed papers, conference presentations, and via social media campaigns.

Consent for publication

Informed consent for publication was provided by the parents of the individuals to be photographed for the purpose of appearing in the intervention materials.

Competing interests

This research was externally funded by two commercial funders (Dove Self-Esteem Project, Unilever and Nike Inc). PCD is an independent consultant for Dove (Unilever). PCD and ELM are independent consultants for Nike Inc. The remaining authors declare that they have no other conflicts of interest in relation to this work.

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Supplementary Information

Additional file 1:

 Supplementary Figure 1. The pilot research design according to the Consolidated Standards of Reporting Trials (CONSORT). Supplementary Table 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. Supplementary Table 2. CONSORT 2010 Checklist and Extension Items for Cluster Randomised Trials. Supplementary Table 3. Coaches’ Demographic and Acceptability Scores for Intervention Pilot. Supplementary Table 4. Girls’ Demographics for the Intervention Pilot. Supplementary Table 5. Girls’ Efficacy Data for the Intervention Pilot. Supplementary Table 6. Girls’ Acceptability and Attendance Data for the Intervention Pilot. Sample of Girls’ Questionnaire administered at Baseline (T1), Post-Intervention (T2), 1-month (T3) and 3-Month (T4) Follow-Up.

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Matheson, E., Schneider, J., Tinoco, A. et al. The co-creation, initial piloting, and protocol for a cluster randomised controlled trial of a coach-led positive body image intervention for girls in sport. BMC Public Health 23, 1467 (2023). https://doi.org/10.1186/s12889-023-16360-w

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