Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05669053 |
| Other study ID # |
HAS.22.11.040 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 7, 2023 |
| Est. completion date |
March 19, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
University of the West of England |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Body image concerns can have serious physical and psychological consequences on young people,
including anxiety, depression, risk taking behaviours, eating disorders and suicidal
ideation.
Micro-interventions (brief, low intensity interventions), offer an alternative to
traditional, intense interventions that aim to immediately improve specific symptoms. Body
image micro-interventions have proven effective at providing immediate and short-term
improvements in body image among adolescents within digital and community settings. To date,
utilising micro interventions in the world of gaming remains unexplored. Specifically, the
Roblox platform which is hugely popular among young people (Roblox, September 2022).
As such, the aim of the present study is to conduct a randomised controlled trial (RCT) to
evaluate the immediate and short-term impact of a Roblox game, Super U story, on American
children and adolescents' body image, mood, internalisation of appearance ideals and social
media literacy. The primary outcome is immediate change in state-based body satisfaction.
Secondary outcomes include immediate changes in state-based mood and body functionality and
short-term changes in trait body esteem, body appreciation, internalisation of appearance
ideals and social media literacy.
The Super U story was developed through a collaboration between Dove (Unilever), Toya (game
developers) and The Centre for Appearance Research. It was specifically designed to target
sociocultural risk and protective factors for body image including social media literacy,
appearance comparisons, positive body image and teasing/bullying around appearance.
The comparison control conditions include an active control; an alternative Roblox game;
Rainbow Friends story which has been matched to the intervention on style, length, and age
appropriateness (omitting body image messaging) and an attention control whereby participants
complete a series of word searches.
To undertake the main trial, 1,479 girls and boys will be recruited through an external
research agency. Participants will be randomised to one of three conditions: 1) the Super U
story intervention, 2) alternative Roblox game or 3) attention control. All participants will
be encouraged to play the game/word search for a maximum of 30 minutes, where they will be
assessed on state-body image and mood immediately before and after completing the game/word
search. All participants will be assessed on trait body esteem, body appreciation,
internalisation of appearance ideals and social media literacy at baseline (one week
pre-intervention) and again at one-week post intervention.
At the end of the study, all participants will receive a debrief form, outlining the study
aims and objectives, and additional resources for body and eating concerns.
Description:
Background:
Extensive research has established that body image issues are evident in early adolescence
and can have far-reaching negative consequences for young people. For instance, poor body
image is predictive of various negative outcomes, including disordered eating, low
self-esteem and mood, and risky health behaviours in early adulthood, such as smoking and
drug use.
Micro-interventions are designed to deliver content that aims to immediately improve specific
symptoms, and they have been applied to adolescent and adult samples with body image and mood
symptoms in community and digital environments. Digitally delivered micro-interventions have
shown promise in improving some body image outcomes in the moment. Importantly, interactive
micro-interventions that require active engagement with its content appear to be more
effective than didactic or passive micro-intervention styles.
Super U intervention:
As such, this project involves the evaluation of 'Super U', a video game-based
micro-intervention designed for American girls and boys. It was created in collaboration with
the Dove Self-Esteem Project and Toya, a gaming studio that creates games for the Roblox
platform, a hugely popular gaming platform among young people with over 57 million daily
users (Roblox, September 2022). Super U is a narrative-based game, which centres around The
Academy - a school for kids with superpowers - under siege by a group of rogue students bent
on spreading negativity. The mission is to help players find their unique superpower of
flight, fire, water, or speed, to dodge and destroy poisonous negativity to help save The
Academy from being overcome. Through the engaging story of Super U, players receive messages
that address known risk factors for poor body image and provide them with strategies that
promote positive body image, such as learning to focus on what their body can do, instead of
what it looks like; recognising that making comparisons can lead to body dissatisfaction;
understanding the importance of critically evaluating messages on social media; and learning
how to deal with appearance-related bullying.
Research questions:
1. Is the intervention acceptable (liked/recommended/children want to continue playing)
among girls and boys in the US?
2. Is the intervention effective in eliciting immediate state-based changes in body image
and mood among girls and boys in the US?
3. Is the intervention effective in eliciting short-term (one week) trait improvements in
body image and related factors among girls and boys in the US?
Design:
To execute this study, the Centre for Appearance Research are collaborating with a research
agency (C&R) based in the US. To test the effectiveness of Super U, we will conduct an online
three-arm randomised controlled trial (RCT) among an equal number of girls and boys from a
range of cities in the US.
Participants:
Recruitment will be outsourced to C&R, a US-based research agency. The research agency will
recruit 90 participants for the pilot and 1479 participants for the main trial. The pilot and
main trial samples will be composed of 50% girls and 50% boys, be evenly split among the age
group (i.e., 9-13 years), and be representative of socioeconomic status and ethnicity. The
research agency will recruit participants via their own recruitment panels of participants
(children and teens) as well as through trusted and fully vetted national sample suppliers
that they have successfully used in the past for research with this target group. Parental
consent will be obtained.
Sample size calculations:
For the pilot, a minimum of N = 30 participants per arm (total sample N = 90) will be
recruited. This recruitment objective was informed by the recommendations by Whitehead and
colleagues, stating that for a main trial designed with 90% power and two-sided 5%
significance, the pilot sample sizes per arm should include a minimum of 25 participants for
standardised effect sizes that are expected to be small (0.2), as the ones of similar online
micro-interventions have been.
For the main trial, the investigators will aim to recruit 1,479 participants (N = 493 per
arm). Considering one primary outcome (state body satisfaction), and one primary end point
(i.e., post-test), an a-priori power analysis based on an ANCOVA model with 3 groups and 3
covariates found that a total sample size of 967 participants would be necessary to detect
small effects (F = 0.10) when considering 80% power and alpha levels of 0.05. Similar studies
testing micro-interventions online show dropout rates at post-test up to 34.39%. The
investigators have therefore inflated the initial sample of 967 by 35% to ensure sufficient
power at post-test. Said inflation resulted in our target sample of 1479 participants, for
which the investigators will aim to have a balanced distribution of gender identities and age
across arms.
Procedure:
All participants will be asked to complete an online questionnaire of trait-based measures
one week prior to receiving the intervention. Participants will complete these trait-based
measures from their home and they will take approximately 30 minutes to complete. The
questionnaires will be hosted on C&R's secure survey platform. Participants who complete the
first questionnaire will then be randomised, into one of 3 groups:
1. Intervention condition: One third of participants will be randomised to receive the
intervention (Super U story) described above.
2. Active control condition: One third of participants will receive an active control
activity in the form of an alternative Roblox game; Rainbow Friends story which has been
matched to Super U in terms of length, age appropriateness, story type and challenges.
3. Attention control condition: One third of participants will receive an attention control
activity (complete word searches).
All participants will have a maximum of 30 minutes to play the game/complete word search.
Outcome measures (described in detail elsewhere):
To assess the immediate impact of playing Super U on body image and mood, all participants
will complete state-based measures for body satisfaction, body functionality, and mood
immediately prior to game play. At the end of game play, participants will complete the same
state-based measures of body satisfaction, body functionality, and mood. Participants will
also complete trait-based measures at follow up (one week after the completion of the
intervention).
Other measures:
Demographics: The baseline questionnaire will capture information on age, gender, ethnicity,
socio-economic status and Roblox game play frequency.
Acceptability: At post-intervention, intervention group participants will answer quantitative
and qualitative questions regarding acceptability of the intervention directly following the
state-based items.
Levels of engagement: At post-intervention, intervention group participants will respond to
questions regarding which parts of the Super U story intervention they engaged with to track
individual engagement with the active ingredients of the intervention.
Data quality measures: Items will be embedded within the surveys to assess data quality
(e.g., questions to evaluate participants' attention).
Pilot study:
Initially, a pilot study will be run in the same format as the main trial (described above)
with the intent to test and confirm the following to refine and validate the research design:
- Confirm recruitment strategy
- Assess the attrition rate for each phase
- Analyse acceptability data
- Assess any other elements that can help support the smooth running of the main trial
- Identify how many people engage with key elements of the game
