Clinical trial NCT06146647: The Evaluation of Two Positive Body Image Micro-interventions for Children Aged 4-6 Years
Official title: Dove Self-Esteem Project: Evaluating Effectiveness and Acceptability of Two Positive Body Image Micro-interventions on Young Children's Body Functionality Appreciation, State Body Appreciation and Anti-fat Attitudes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Image
Anti Fat Bias
Keywords: weight stigma
anti-fat bias
body appreciation
body functionality
body satisfaction
body dissatisfaction
children's media
music video
body image
Lead sponsor: University of the West of England
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2023-11-24
Enrollment: 440
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this 4-arm randomized controlled trial is to test the effectiveness of two positive body image media micro interventions (a tv show and a music video) in improving body image related constructs.

The main questions this study aims to answer are:

1. Relative to time-matched active controls, are the two positive body image media micro-interventions effective in yielding immediate improvements in children's body functionality appreciation and body appreciation and in reducing anti-fat attitudes?
2. Are the two positive body image media micro-interventions acceptable to children and their participating parent/guardian?

An additional five secondary exploratory research questions are described below \[in the description section\].

Participants will be recruited into the trial by a research agency via their parents/guardians. Once recruited, they will be randomised into one of 4 conditions:

* 15-minute TV intervention
* 15-minute active TV control
* 3-minute music video intervention
* 3-minute active music video control

Children (and their parent or guardian) will visit a testing centre in groups of approximately 12 dyads. Children will complete T1 assessment interviews one-on-one with a researcher, before watching their assigned media with their parent. After watching their assigned media, children will complete their T2 assessment, again one-to-one with a researcher, while parents complete a survey regarding their acceptability of the media they watched. Parents/guardians will be given a link to rewatch their assigned media and encouraged to rewatch with their child before returning to the testing centre approximately one week later. When children and parents/guardians return one week later, the child will complete T3 assessment interviews one-to-one with a researcher, and parents will complete a short survey regarding their rewatch habits.

Researchers will compare the two positive body image media micro-interventions with their time-matched active controls to examine if they are effective in yielding immediate improvements in children's body functionality appreciation and body appreciation and in reducing anti-fat attitudes.

Detailed description: Body Image in Childhood

Body image develops in early childhood (Grogan et al., 2021) and by age four children report negative feelings towards their body and negative attitudes (e.g., anti-fat bias) towards others (Bensley et al., 2023; Paxton \& Damiano, 2017). Body image concerns are associated with low self-esteem, disordered eating and academic disengagement (Bornioli et al., 2019) as children emerge into adolescence. As such, it is important to intervene and implement age-appropriate prevention strategies as early as possible. One key prevention strategy, endorsed by scholars and body image experts (e.g., Daniels \& Roberts, 2018), is to foster positive body image among children through the development and evaluation of interventions.

Children's Media

Children's media has proven a powerful tool in educating young children, with countless shows designed to assist language development, moral understanding and pro-social behaviour (e.g., Sesame Street; Fisch \& Truglio (2014), Daniel's Tiger; Rasmussen et al., 2016). However, only a small portion of these have undergone rigorous scientific evaluation and even fewer target positive body image. One study evaluated short-animated stories targeting risk and protective factors for body image among 7 - 10 year olds and found improvements in state body satisfaction, trait media literacy and pro-social behaviours with effects maintained at 1-week follow-up (Matheson et al., 2020). Other successful media-based approaches among older demographics have included online games (e.g., Matheson et al, 2022), e-books (e.g., Matheson et al., in prep) and traditional board games (e.g., Guest et al., 2021).

The Current Interventions

The positive body image media micro-interventions to be evaluated are currently being developed. The first intervention, a TV episode, centres around a talent show and teaches children to discover and love the wonderful and exciting things their bodies can do. Specifically, the episode follows the story of a young boy who wants to take part in a talent show but lacks confidence in a particular dance move. He, and some of the other talented dancers in the tv show, live in a larger body, thus disrupting traditionally held size stereotypes. The second positive body image media micro-intervention, a music video, also showcases diverse body sizes. The lyrics in the song, sung to the tune of 'Head, Shoulders, Knees and Toes', details all the amazing things our bodies can do and models the characters expressing love for their body. The content is based on existing empirical evidence, knowledge about body image and includes two main themes:

1. Body Functionality Appreciation (focusing on what the body can do rather than what it looks like).
2. Acceptance of Appearance Diversity (celebrating that everybody is different, and people come in all shapes and sizes).

This project will include a pilot study, followed by a fully powered randomised controlled trial (RCT). The purpose of the pilot study is to check the research design and protocols are fit for purpose.

Specifically, a stop/go protocol will be followed.

The research team will PROCEED to the main trial provided:

1. at least 80% of the data is considered 'usable' (based on participant attendance, non-completion, participant engagement and comprehension)
2. There is no evidence of ceiling effects for the measures at T1.
3. There is no evidence of harm (ie., child distress due to the content of the micro-interventions or the research process).

The research team will REVIEW research processes if:

1. Between 60-80% of the data is usable
2. There is some evidence of ceiling effects at T1
3. There is some evidence of participant distress (between 1-10% of participants)

The research team will NOT proceed to the main trial if:

1. Less than 60% of the data is usable
2. Every measure demonstrates ceiling effects
3. There is evidence that more than 10% of participants experience distress

Should the study proceed to a main trial, the aims, research questions and hypotheses of the main trial are as follows;

RQ1. Relative to time-matched active controls, are the two positive body image media micro-interventions effective in yielding immediate improvements in children's body functionality appreciation and body appreciation and in reducing anti-fat attitudes?

H1: The researchers anticipate children randomised into one of the interventions conditions to experience an immediate improvement (T2) in body functionality appreciation and body appreciation, relative to the control groups. The researchers also expect the intervention groups to report an immediate reduction in anti-fat attitudes (T2), relative to the control groups.

RQ2. Are the two positive body image media micro-interventions acceptable to children and their participating parent/guardian?

H2. The researchers expect the two positive body image media micro-interventions to be enjoyed by children and viewed as age appropriate and relevant by their participating parent/guardian.

Further, there are five exploratory research questions, examining moderators, exposure effects, and sustained effects:

RQ3. Does gender moderate intervention effectiveness?

H3. The researchers predict that the intervention will be more effective for girls than for boys.

RQ4. Does year group moderate intervention effectiveness?

H4. The researchers predict that the intervention will be more effective for children in year 1 than children in reception.

RQ5. Are there within-group intervention effects whereby repeated exposure to either one of the positive body image media micro-interventions is positively correlated to improvements at T3?

H5. The researchers expect that children within each intervention condition (e.g., TV and music video) will experience greater improvements to body functionality appreciation and body appreciation and greater reductions in anti-fat attitudes, at one-week follow up (T3) the more they have watched their content from T2 to T3.

RQ6. Is there a difference in terms of the immediate pre-post effectiveness outcomes between the two interventions?

H6. The researchers anticipate the 15-minute intervention will be more effective than the 2/3-minute music video on the premise that there will be greater exposure to core messaging.

RQ7. Are there sustained effects approximately one week following media exposure, controlling for repeat watching?

H7: The researchers anticipate to see sustained effects in our outcome measures at one week follow-up, relative to the control condition, controlling for repeat watching.

Eligibility criteria: Inclusion Criteria:

1. Child is aged 4, 5, or 6 years old
2. Child is currently in reception or Year 1 of primary school
3. The child's parent/guardian resides in Greater London or the Midlands.

Exclusion Criteria:

1. Child has complex special educational needs
2. Child is a sibling of a child already recruited into the study
3. Child is not English speaking
4. Child is home-schooled

Primary outcomes:
measure: Change in body appreciation
timeFrame: Baseline; post-intervention (immediate post); follow-up (10 days later)
Secondary outcomes:
measure: Change in anti-fat attitudes
timeFrame: Baseline; post intervention (immediate post); follow-up (10 days later)
measure: Change in body functionality appreciation
timeFrame: Baseline; post intervention (immediate post); follow-up (approx. 10 days later)
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Centre for Appearance Research, UWE
Study officials:
affiliation: University of the West of England
name: Nadia Craddock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bensley J, Riley HO, Bauer KW, Miller AL. Weight bias among children and parents during very early childhood: A scoping review of the literature. Appetite. 2023 Apr 1;183:106461. doi: 10.1016/j.appet.2023.106461. Epub 2023 Jan 13.
citation: Guest E, Jarman H, Sharratt N, Williamson H, White P, Harcourt D, Slater A; VTCT Foundation Research Team at the Centre for Appearance Research. 'Everybody's Different: The Appearance Game'. A randomised controlled trial evaluating an appearance-related board game intervention with children aged 9-11 years. Body Image. 2021 Mar;36:34-44. doi: 10.1016/j.bodyim.2020.09.010. Epub 2020 Nov 5.
citation: Matheson EL, Lewis-Smith H, Diedrichs PC. The effectiveness of brief animated films as a scalable micro-intervention to improve children's body image: A randomised controlled trial. Body Image. 2020 Dec;35:142-153. doi: 10.1016/j.bodyim.2020.08.015. Epub 2020 Oct 10.
citation: Matheson, E. L., Smith, H. G., Lewis-Smith, H., Arbon, R. E., & Diedrichs, P. C. (2022). Game on! A randomised controlled trial evaluation of playable technology in improving body satisfaction and negative affect among adolescents. new media & society, 24(12), 2635-2658.
citation: Paxton SJ, Damiano SR. The Development of Body Image and Weight Bias in Childhood. Adv Child Dev Behav. 2017;52:269-298. doi: 10.1016/bs.acdb.2016.10.006. Epub 2016 Dec 9.
citation: Rasmussen, E. E., Shafer, A., Colwell, M. J., White, S., Punyanunt-Carter, N., Densley, R. L., & Wright, H. (2016). Relation between active mediation, exposure to Daniel Tiger's Neighborhood, and US preschoolers' social and emotional development. Journal of Children and Media, 10(4), 443-461.