Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146647
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2023-11-15
Brief Title:
The Evaluation of Two Positive Body Image Micro-interventions for Children Aged 4-6 Years
Sponsor:
University of the West of England
Organization:
University of the West of England
Study Overview
Official Title:
Dove Self-Esteem Project Evaluating Effectiveness and Acceptability of Two Positive Body Image Micro-interventions on Young Childrens Body Functionality Appreciation State Body Appreciation and Anti-fat Attitudes
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childrens 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 parentguardian
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 parentsguardians 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 Parentsguardians 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 parentsguardians 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 childrens body functionality appreciation and body appreciation and in reducing anti-fat attitudes
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 childrens 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 parentguardian
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 parentsguardians 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 Parentsguardians 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 parentsguardians 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 childrens 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 eg 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 eg Daniels Roberts 2018 is to foster positive body image among children through the development and evaluation of interventions
Childrens Media
Childrens media has proven a powerful tool in educating young children with countless shows designed to assist language development moral understanding and pro-social behaviour eg Sesame Street Fisch Truglio 2014 Daniels 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 eg Matheson et al 2022 e-books eg Matheson et al in prep and traditional board games eg 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 stopgo 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 childrens 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 parentguardian
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 parentguardian
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 eg 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 23-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
Body image develops in early childhood Grogan et al 2021 and by age four children report negative feelings towards their body and negative attitudes eg 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 eg Daniels Roberts 2018 is to foster positive body image among children through the development and evaluation of interventions
Childrens Media
Childrens media has proven a powerful tool in educating young children with countless shows designed to assist language development moral understanding and pro-social behaviour eg Sesame Street Fisch Truglio 2014 Daniels 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 eg Matheson et al 2022 e-books eg Matheson et al in prep and traditional board games eg 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 stopgo 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 childrens 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 parentguardian
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 parentguardian
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 eg 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 23-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None