- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06146647
The Evaluation of Two Positive Body Image Micro-interventions for Children Aged 4-6 Years
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
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:
- 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?
- 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.
Study Overview
Status
Conditions
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:
- Body Functionality Appreciation (focusing on what the body can do rather than what it looks like).
- 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:
- at least 80% of the data is considered 'usable' (based on participant attendance, non-completion, participant engagement and comprehension)
- There is no evidence of ceiling effects for the measures at T1.
- 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:
- Between 60-80% of the data is usable
- There is some evidence of ceiling effects at T1
- There is some evidence of participant distress (between 1-10% of participants)
The research team will NOT proceed to the main trial if:
- Less than 60% of the data is usable
- Every measure demonstrates ceiling effects
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nadia Craddock, PhD
- Phone Number: +441173287924
- Email: nadia.craddock@uwe.ac.uk
Study Contact Backup
- Name: Heidi Williamson, CPsychol
- Phone Number: +441173281572
- Email: heidi3.williamson@uwe.ac.uk
Study Locations
-
-
-
Bristol, United Kingdom, BS16 1QY
- Recruiting
- Centre for Appearance Research, UWE
-
Contact:
- Nadia Craddock, PhD
- Email: nadia.craddock@uwe.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child is aged 4, 5, or 6 years old
- Child is currently in reception or Year 1 of primary school
- The child's parent/guardian resides in Greater London or the Midlands.
Exclusion Criteria:
- Child has complex special educational needs
- Child is a sibling of a child already recruited into the study
- Child is not English speaking
- Child is home-schooled
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention condition: 15 minute (approx.) show with positive body image messaging
Those assigned to this arm will watch the 15 minute tv show with positive body image content.
|
This is a 15 minute (approximately) show that has positive body image content embedded in the storyline.
It also showcases a diverse range of body sizes in the casting.
|
Active Comparator: Control condition: 15 minute (approx.) show without positive body image messaging
Those assigned to this condition will watch a 15 minute tv show that does not contain positive body image content. The show that will be used for this condition is about a tv character visiting the dentist. |
14 minute tv show following a tv character as he visits the dentist.
|
Experimental: Intervention condition: Music video with positive body image messaging
Those assigned to this condition will watch the music video containing positive body image messaging.
|
This is a positive body image song with strong visual representation of diverse body sizes in the music video.
|
Active Comparator: Control condition: Music video without positive body image content
Those assigned to this condition will watch a music video without positive body image messaging. The music video that will be used for this condition is about brushing teeth. |
Music video of a tv character singing about brushing teeth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body appreciation
Time Frame: Baseline; post-intervention (immediate post); follow-up (10 days later)
|
Participants respond to two 4-point Likert scale questions, 'Do you love your body?' and 'Do you think your body is amazing?' (No, a little, bit, a medium bit, a lot)
|
Baseline; post-intervention (immediate post); follow-up (10 days later)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anti-fat attitudes
Time Frame: Baseline; post intervention (immediate post); follow-up (10 days later)
|
Children rate a smaller child character and a larger child character on five dimensions (e.g. is this child cute, ugly, or somewhere in the middle?).
Child character to be matched as closely as possible on gender and ethnicity to participant.
|
Baseline; post intervention (immediate post); follow-up (10 days later)
|
Change in body functionality appreciation
Time Frame: Baseline; post intervention (immediate post); follow-up (approx. 10 days later)
|
Participants have a minimum of 60 seconds to tell the moderator all the amazing things that they can do with their body.
A frequency score will be calculated (i.e., the number of things a participant thinks there body can do that is amazing).
Change will be measured as a frequency.
This is a bespoke, purpose built measure.
|
Baseline; post intervention (immediate post); follow-up (approx. 10 days later)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nadia Craddock, PhD, University of the West of England
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DSEP_GOOSE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Body Image
-
University of SheffieldCompletedBody Image Disturbance | Body Image | ShameUnited Kingdom
-
Trakya UniversityMedipol UniversityCompleted
-
Duke UniversityTerminatedImage, BodyUnited States
-
University of the West of EnglandUnilever R&D; UNICEF; Deakin University; Talk 2 U; Instituto Federal Sudeste de Minas...Completed
-
University of the West of EnglandTata Institute of Social Sciences; Lady Shri Ram College for WomenCompleted
-
Chapman UniversityOhio State UniversityUnknown
-
University College DublinIrish Research Council; Jigsaw, The National Centre for Youth Mental Health... and other collaboratorsRecruiting
-
University of the West of EnglandUniversity of Hawaii; Indonesia University; Unilever R&DCompletedBody ImageUnited Kingdom
-
University of the West of EnglandUnilever R&D; C+R research agencyCompleted
Clinical Trials on Positive body image TV show
-
University of PadovaCompletedBody Image Disorder | Body Dysmorphic Disorders | Eating DisordersItaly
-
Norwegian School of Sport SciencesUniversity of Tromso; University of Agder; University College of Southeast Norway and other collaboratorsCompletedQuality of Life | Physical Activity | Eating BehaviorsNorway
-
Newbridge HouseCompletedBody Image | Exposure
-
University of the West of EnglandUnilever R&D; UNICEF; Deakin University; Talk 2 U; Instituto Federal Sudeste de Minas...Completed
-
University of SheffieldCompletedBody Image Disturbance | Eating Disorder SymptomUnited Kingdom
-
Dr. Feiz & AssociatesRecruitingWeight Loss | Bariatric SurgeryUnited States
-
The Miriam HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
National Institute of Diabetes and Digestive and...Completed
-
Peking University Third HospitalRecruitingAnterior Cruciate Ligament Injuries | Cartilage DegenerationChina