Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05023213 |
| Other study ID # |
DSEP_GE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 30, 2021 |
| Est. completion date |
January 26, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
University of the West of England |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The researchers will 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,
appearance-related life engagement, 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
will complete single-item measures of body dissatisfaction and mood immediately before and
after watching each episode. Further exploratory analyses are also planned.
Approximately 1800 young Indonesian women will be recruited for this research project.
The study's hypotheses are as follows:
1. Participants randomised to the intervention condition will experience reduced body
dissatisfaction, skin shade dissatisfaction, and internalisation of appearance ideals,
as well as improvements in appearance-related life engagement and mood, at
post-intervention, and one-month follow-up, relative to the waitlist control condition.
2. Each video in the Warna-Warni Waktu series will elicit immediate state-based
improvements in body satisfaction and mood.
3. Greater engagement and adherence in the Warna-Warni Waktu intervention will result in
greater reducing in body dissatisfaction, skin shade dissatisfaction, and
internalisation of appearance ideals, as well as improvements in appearance-related life
engagement, and mood. This analysis will be 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 will be recruited using a local research agency's database of previous research
participants.
Previous participants over the age of 40 will be 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 will be eligible. If the respondent does not have a
daughter between 15 and 19 years of age, the recruiter will enquire if the respondent knows
another family with a daughter of this age. If so, the recruiter will request the telephone
number of that family in order to make contact. Only one phone number will be requested per
call.
Should an eligible daughter be 15-17 years old, the recruiter will read the parental
information sheet to the parent. Parents will then be requested to provide verbal consent for
the daughter's participation, as well as verification of the parents' identity and daughter's
age. Parents will 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 will request a call back. The daughter will then be screened for eligibility and
informed verbal assent obtained. Following a successful call, the parental information sheet
will be 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
will occur. Parents will 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 will be completed by the daughters, in the same
manner with which it will be completed by parents of those aged 15-17 years. Verification of
identities and ages will be 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 - 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 was used.
Four risk factors for the development of body image concerns were identified by the
researchers as relevant: 1) social media and influencers 2) appearance-based comparisons 3)
appearance-based teasing, and 4) body talk. Each of these risk factors were 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) were 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 will enter the study (i.e., complete the baseline assessment questionnaire)
on the same day (Day 1). Participants will 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), will be sent to participants via WhatsApp, along with a unique
participant identification number (PIN). Participants will be requested to enter the PIN on
the first page of the baseline survey, in order to match participant responses over time.
Participants will have 24 hours to complete the baseline assessment; participants that have
not completed the baseline assessment within the first 8 hours will be sent a reminder
message. Following the 24-hour window, participants who have completed the baseline
assessment will be randomised into one of the two conditions. Participants will be alerted on
Day 2 to what happens next, depending on which condition each has been randomised.
Participants randomised to the intervention condition will be informed to expect a series of
links to be sent over the following six days. Participants in the control condition will be
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 will be sent the unique
PIN and a link to the first video in the intervention. Again, participants will be requested
to enter the unique PIN on the first page of the link. Before watching video one in the
Warna-Warni Waktu series, participants will complete state measures of body satisfaction and
affect. State measures of body satisfaction and affect will be asked again, immediately after
the video. Next, participants will be 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 will be sent a link to complete the
second assessment. As with the baseline assessment, participants will be given 24 hours to
complete this assessment, with reminder messages sent to non-completers after the first eight
hours. The same process will be executed for the third and final assessment, one month later
on Day 37.
Following the third assessment, all participants will be 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 will be provided with a link to the
Warna-Warni Waktu video series to watch if desired.
