Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05383807 |
Other study ID # |
PRR1-10.2196/33596 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 13, 2021 |
Est. completion date |
December 12, 2021 |
Study information
Verified date |
March 2022 |
Source |
University of the West of England |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The researchers conduct a randomised controlled trial to evaluate a social media-based
intervention aimed at reducing body dissatisfaction among young Indonesian women between 15
and 19 years old.The intervention (titled Warna-Warni Waktu) consists of six sequential
videos that tell a fictional story of a typical Indonesian young woman. The videos address
known risk factors for body dissatisfaction and include evidence-based techniques to mitigate
body dissatisfaction. In addition, the intervention encompasses 18 short online activities
intended to encourage participants to think critically about the messages learnt in the
videos and practice applying the lessons in real life.
The primary aim is to evaluate the short-term (immediate and four-week post) impact of the
intervention on young Indonesian women. The primary outcome is trait body dissatisfaction.
Secondary outcomes include internalisation of societal appearance ideals, mood, and skin
shade satisfaction.
The second aim is to evaluate the effectiveness of the videos individually on eliciting
state-based improvements (i.e., improvements in the moment) in body dissatisfaction and mood.
This will be a within-group design, whereby only participants in the intervention condition
complete single-item measures of body dissatisfaction and mood immediately before and after
watching each episode. Further exploratory analyses are also planned.
Approximately 2000 young Indonesian women are recruited for this research project.
The study's hypotheses are as follows:
1. Participants randomised to the intervention condition experience improved body
satisfaction, mood, and skin shade satisfaction, and reduced internalisation of
appearance ideals at post-intervention (1 day following the intervention), and 1 month
follow-up, relative to the waitlist control condition.
2. Each video in the Warna-Warni Waktu series elicits immediate state-based improvements in
body satisfaction and mood.
3. Greater engagement and adherence in the Warna-Warni Waktu intervention results in
greater body satisfaction, mood, skin shade satisfaction, and reduced internalisation of
appearance ideals. This analysis is exploratory in nature, depending on participants'
engagement and adherence in the intervention during the trial.
Description:
Background
There is a need for culturally-relevant, accessible, and scalable prevention efforts to
reduce body dissatisfaction and improve positive body image among Indonesian girls.
Currently, no body image interventions for this population exist.
Recruitment
Participants are recruited using a local research agency's database of previous research
participants.
Previous participants over the age of 40 are contacted via telephone and screened regarding
having a daughter within the eligible age range. If the respondent has more than one daughter
in the age range, only one is eligible. If the respondent does not have a daughter between 15
and 19 years of age, the recruiter enquires if the respondent knows another family with a
daughter of this age. If so, the recruiter requests the telephone number of that family in
order to make contact. Only one phone number is requested per call.
Should an eligible daughter be 15-17 years old, the recruiter reads the parental information
sheet to the parent. Parents are then requested to provide verbal consent for the daughter's
participation, as well as verification of the parents' identity and daughter's age. Parents
then answer questions relating to the family's socio-economic status before the recruiter
requests to speak to the daughter. If the daughter is not present, the recruiter requests a
call back. The daughter is then screened for eligibility and informed verbal assent obtained.
Following a successful call, the parental information sheet is sent to the parent via
WhatsApp, and written informed parental consent obtained.
Should an eligible daughter be aged 18 or 19 years old, a similar pattern of communication
occurs. Parents verify the age of the parents and the daughter, and respond to questions
regarding the family's socio-economic status. Rather than parents providing informed verbal
and written consent, this is completed by the daughters, in the same manner with which it is
completed by parents of those aged 15-17 years. Verification of identities and ages is
achieved through video calls via the presentation of a National ID card and family
registration card.
Intervention
The intervention, Warna-Warni Waktu (translation to English: Colourful Time Travel), was
developed over a 20-month period, from October 2019 to May 2021. In addition to the close
collaboration amongst body image academics, creative agencies, social media specialists,
not-for-profit organisations, as well as industry funders, development involved three rounds
of feedback from the intervention's target audience.
The narrative story told in the six-video series is based on the concept of time travel so as
to convey the additive impact of body image concerns to young people. A combination of both
animated characters and real people are used.
Four risk factors for the development of body image concerns are relevant, as identified by
the researchers: 1) social media and influencers 2) appearance-based comparisons 3)
appearance-based teasing, and 4) body talk. Each of these risk factors are targeted in videos
two through five, with videos one and six being the introductory and concluding videos. Each
video is four to five minutes in length. A number of change techniques (including those based
upon psychoeducation and media literacy) are embedded within the videos.
Each video is accompanied by one to five short interactive activities, designed to elicit
cognitive dissonance. Research consistently shows body image interventions that are
interactive generate the most positive outcomes.
Procedure
All participants enter the study (i.e., complete the baseline assessment questionnaire) on
the same day (Day 1). Participants receive a data package a day prior to this from the
research agency to ensure participants have ample mobile phone data to allow participation in
the study. A link to the baseline assessment, hosted on Qualtrics (Qualtrics, Provo, UT), is
sent to participants via WhatsApp, along with a unique participant identification number
(PIN). Participants are requested to enter the PIN on the first page of the baseline survey,
in order to match participant responses over time. Participants have 24 hours to complete the
baseline assessment; participants that have not completed the baseline assessment within the
first 8 hours are sent a reminder message. Following the 24-hour window, participants who
have completed the baseline assessment are randomised into one of the two conditions.
Participants are alerted on Day 2 to what happens next, depending on which condition each has
been randomised. Participants randomised to the intervention condition are informed to expect
a series of links to be sent over the following six days. Participants in the control
condition are informed that contact will be made again in one weeks' time to complete a
second assessment.
On the third day (Day 3), participants in the intervention condition are sent the unique PIN
and a link to the first video in the intervention. Again, participants are requested to enter
the unique PIN on the first page of the link. Before watching video one in the Warna-Warni
Waktu series, participants complete state measures of body satisfaction and affect. State
measures of body satisfaction and affect are asked again, immediately after the video. Next,
participants are presented with the reinforcer activities for video one to complete. This
process is repeated on Days 4-8, for videos two-six.
On Day 9 of the study, participants in both conditions are sent a link to complete the second
assessment. As with the baseline assessment, participants are given 24 hours to complete this
assessment, with reminder messages sent to non-completers after the first eight hours. The
same process is executed for the third and final assessment, one month later on Day 37.
Following the third assessment, all participants are debriefed on the study aims and provided
with additional sources of mental health support, as well as a certificate of participation.
Those in the waitlist control condition are provided with a link to the Warna-Warni Waktu
video series to watch, if desired.