Body ImageNCT05383807
Evaluating a Social Media-Based Intervention to Reduce Body Dissatisfaction Among Young Indonesian Women
A study testing Warna-Warni Waktu in people with Body Image, run by University of the West of England at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Image
- What is being tested?
- Warna-Warni Waktu
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Sep 2021to 12 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- identifying as a girl
- aged between 15 and 19 years old
- own their own mobile phone
- access Facebook or Instagram daily.
Who cannot join
- follow the Girl Effect brand ('Springster') on any social media site
- have ever accessed the Springster website
- if under 18 years of age, do not have the written consent from a parent or guardian.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of a Social Media-Based Intervention ("Warna-Warni Waktu") to Reduce Body Dissatisfaction Among Young Indonesian Women: Parallel Randomized Controlled Trial
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.
Read more
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:
- 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.
- Each video in the Warna-Warni Waktu series elicits immediate state-based improvements in body satisfaction and mood.
- 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.
Read the detailed 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.
- Conditions
- Body Image
- Being tested
- Warna-Warni Waktu
- Keywords
- body dissatisfaction, body satisfaction, positive body image
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warna-Warni WaktuBehavioural
Six videos and eighteen reinforcer activities
| Study group | Role | What they receive |
|---|---|---|
| Warna-Warni Waktu intervention | Experimental | Participants in this condition are asked to view six, approximately five-minute videos (each with a number of associated short, interactive reinforcer activities), at a pace of one video per day, for 6 days. Receives: Behavioral: Warna-Warni Waktu |
| Waitlist control condition | No intervention | These participants are not contacted during the intervention timeframe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body esteem
Body esteem (body satisfaction) is assessed using the Body Esteem Scale for Adolescents \& Adults (Mendelson, Mendelson \& White, 2001), newly validated among Indonesian adolescents prior to the trial. Once the appropriate items are reverse coded, scores on all items are averaged; with higher scores indicating higher body esteem.
Measured: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)
Secondary outcomes (5)
Change in internalisation of societal appearance ideals
Internalisation of societal appearance ideals is assessed using The Sociocultural Attitudes Towards Appearance Questionnaire-3 (SATAQ-3): General Subscale (Thompson, van de Berg, Roehrig, Guarda, \& Heinberg, 2004), newly validated among Indonesian adolescents prior to the trial. Scores are averaged, with higher scores indicating higher internalisation.
Measured: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)
Change in mood
Positive and negative mood is measured using the Positive and Negative Affect Schedule for Children (Laurent, Catanzaro, Joiner, Rudolph, Potter, Lambert, Osborne, \& Gathright, 1999), newly validated among Indonesian adolescents prior to the trial. Scores on each subscale are averaged; with higher scores indicating greater negative affect and positive affect respectively.
Measured: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)
Change in skin shade satisfaction
Single-item, purpose built measure to assess satisfaction with skin shade.
Measured: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)
Change in state body satisfaction
State body satisfaction is measured using a 101-point visual analogue scale (Heinberg \& Thompson, 1995)
Measured: Immediately before and after watching each of the six intervention videos.
Change in state mood
State mood is measured using a 101-point visual analogue scale (Heinberg \& Thompson, 1995)
Measured: Immediately before and after watching each of the six intervention videos.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start13 Sep 2021
- Primary completion12 Dec 2021
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body ImageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D, University of Hawaii, Universitas Indonesia
- Responsible party
- Sponsor
- Investigators
- Kirsty Garbett, MSc, Principal investigator, University of the West of England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383807
- Sponsor's protocol ID
- PRR1-10.2196/33596
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garbett KM, Haywood S, Craddock N, Gentili C, Nasution K, Saraswati LA, Medise BE, White P, Diedrichs PC, Williamson H. Evaluating the Efficacy of a Social Media-Based Intervention (Warna-Warni Waktu) to Improve Body Image Among Young Indonesian Women: Parallel Randomized Controlled Trial. J Med Internet Res. 2023 Apr 3;25:e42499. doi: 10.2196/42499.
PubMed 37010911
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Social Media-Based Intervention ("Warna-Warni Waktu") to Reduce Body Dissatisfaction Among Young Indonesian Women: Parallel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05383807
- Acronym / sponsor ID
- PRR1-10.2196/33596
- Conditions
- Body Image
- Keywords
- body dissatisfaction, body satisfaction, positive body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Collaborators
- Unilever R&D, University of Hawaii, Universitas Indonesia
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Each video in the Warna-Warni Waktu series elicits immediate state-based improvements in body satisfaction and mood.
- 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warna-Warni Waktu intervention | Experimental | Behavioral: Warna-Warni WaktuParticipants in this condition are asked to view six, approximately five-minute videos (each with a number of associated short, interactive reinforcer activities), at a pace of one video per day, for 6 days. |
| Waitlist control condition | No intervention | –These participants are not contacted during the intervention timeframe. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- identifying as a girl
- aged between 15 and 19 years old
- own their own mobile phone
- access Facebook or Instagram daily.
Key exclusion criteria (3 listed)
- follow the Girl Effect brand ('Springster') on any social media site
- have ever accessed the Springster website
- if under 18 years of age, do not have the written consent from a parent or guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warna-Warni WaktuSix videos and eighteen reinforcer activities | Behavioural | Warna-Warni Waktu intervention |
Primary outcome
Change in body esteem
Time frame: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)
Body esteem (body satisfaction) is assessed using the Body Esteem Scale for Adolescents \& Adults (Mendelson, Mendelson \& White, 2001), newly validated among Indonesian adolescents prior to the trial. Once the appropriate items are reverse coded, scores on all items are averaged; with higher scores indicating higher body esteem.
5 secondary outcomes
Change in internalisation of societal appearance ideals
Time frame: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)
Change in mood
Time frame: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)
Change in skin shade satisfaction
Time frame: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)
Change in state body satisfaction
Time frame: Immediately before and after watching each of the six intervention videos.
Change in state mood
Time frame: Immediately before and after watching each of the six intervention videos.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 37010911Garbett KM, Haywood S, Craddock N, Gentili C, Nasution K, Saraswati LA, Medise BE, White P, Diedrichs PC, Williamson H. Evaluating the Efficacy of a Social Media-Based Intervention (Warna-Warni Waktu) to Improve Body Image Among Young Indonesian Women: Parallel Randomized Controlled Trial. J Med Internet Res. 2023 Apr 3;25:e42499. doi: 10.2196/42499.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsty Garbett, MSc principal investigator
University of the West of England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warna-Warni Waktu in people with Body Image, run by University of the West of England at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body esteem (time frame: baseline; post-intervention (1 day after the intervention is complete); follow-up (4 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05383807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.