Body ImageNCT04665557
Evaluating Dove Confident Me Single Session in Indonesia
A study testing Dove Confident Me Indonesia Single Session in people with Body Image, run by University of the West of England at 1 site in United Kingdom.
Trial summary
Negative body image is an important public health concern for young people due to its prevalence and detrimental impact on young people's health, education, and social life. Encouragingly, a number of interventions have been designed to improve adolescent body image in school settings, with promising results. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Image
- What is being tested?
- Dove Confident Me Indonesia Single Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,926 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 1 Jul 2022
- 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All participating schools must be state junior secondary schools.
- Students in grade 7 through 9 are eligible.
- Students must speak Bahasa Indonesia and must have moderate-high literacy. levels in Bahasa Indonesia - i.e., need to be able to read on their own.
- Students must have access to a device with online access (e.g., laptop or iPad).
Who cannot join
- Non-Bahasa Indonesia speaking students.
- Religious or private schools.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Appearance Research, UWE
Bristol, BS16 1QY
About this study
Official title: Evaluating "Dove Confident Me Indonesia"; A School-Based Single Session Intervention to Improve Body Image and Wellbeing Among Indonesian Adolescents
Negative body image is an important public health concern for young people due to its prevalence and detrimental impact on young people's health, education, and social life. Encouragingly, a number of interventions have been designed to improve adolescent body image in school settings, with promising results. However, the vast majority of studies testing these interventions are conducted in high-income, English speaking countries, despite increasingly recognition that negative body image is a global concern. As such, it is important to develop and disseminate interventions to foster positive body image among adolescents in low-to-middle income countries, too.
Research indicates high prevalence rates of negative body image among adolescents in many Asian countries. Indonesia - the focus of the present research - is an emerging middle-income country in South East Asia. A recent U-Report Poll (UNICEF, 2020) found almost 80% of the young people surveyed wanted to change something about their appearance, suggesting a degree of body dissatisfaction and approximately 50% stopped themselves from doing something that was important to them because of appearance concerns. Moreover, according to the same poll, over 90% of Indonesian adolescents surveyed reported to wanting to learn ways to improve their body image in school or online.
Read more
To date, no body image interventions have been adapted and trialled in Indonesia. Therefore, this project aims to evaluate the effectiveness as well as the acceptability and feasibility of a specially adapted version of Dove Confident Me Single Session among Indonesian adolescents that will be integrated into UNICEF's Life Skills Education curriculum. Notably, the session has been designed to be feasible to deliver in low-resource schools (e.g., that do not access to the internet or facilities to show videos or PowerPoint slides).
To assess the acceptability, feasibility, and effectiveness of the intervention, the study will compare the body image and well-being of students who take part in the programme to students who do not take part in any programme (classes as usual). Investigators will also gather in-depth feedback from students, and teachers via focus groups and surveys, in order to inform future improvement of the programme for wider implementation.
To undertake this project, the investigators will recruit students and teachers from approximately 10 state junior secondary schools in Indonesia via a local research agency. Students will complete questionnaire assessments of body image and well-being before and after programme period, and again 8 weeks later to assess longer-term benefits.
COVID response: In light of the ongoing pandemic, some research activities will take place online. Decisions on delivery format (online / in-person / hybrid) were made on the basis of continued risk assessments and considerations of local government guidelines.
Read the detailed description
Detailed COVID Response Description. Though the intervention was specifically designed to be delivered in person and avoided the use of technology to make it accessible to as many Indonesian adolescents as possible, circumstances with COVID-19 have meant that aspects of trial need to be conducted online to minimise undue harm and the spread of infection. Decisions on delivery format were based on regular risk assessments and considerations of local government guidelines. Accordingly, the internal pilot was conducted entirely online as most schools were exclusively offering remote learning and the risk in the area was high. In contrast, shortly following the commencement of the main trial, schools in Surabaya returned to 100% in person teaching (January 2022). Consequently, some research activities, including the lesson, took place in school while sticking to health and safety measures (e.g., social distancing, wearing masks, etc.).
Teacher training will include self-directed learning via UNICEF's teacher training e-module for Life Skills Curriculum which includes the intervention of focus on body image. Teachers will then attend two online training sessions with a member of the research team who is trained in delivering the intervention. These sessions will run through background knowledge about body image, propose how we expect the lesson to look, give the opportunity for teachers to ask questions, and explore common questions/statements from students.
Schools will be recruited for the study via email correspondence from the research agency in Indonesia and information sheets will be sent out to parents/guardians. Parents/guardians will provide informed consent to the school. Students will provide informed consent to the school and during the baseline assessment. Students will complete the surveys across three time points via Qualtrics on personal devices at home or at school. The acceptability focus groups with teachers and students from the intervention condition will take place via a video conferencing platform such as Zoom. The intervention will be delivered online via video conferencing platform.
To ensure this method of the trial is feasible, we need to ensure students have access to a device (laptop or iPad), have a stable internet connection and are familiar with video conferencing platforms for learning. To meet these demands, we will recruit in higher SES areas.
Further, given that we did not initially plan to conduct any aspects of the trial online, we ran an internal acceptability pilot. That is, we tested the feasibility and acceptability of key study elements - i.e., administering the surveys online across three timepoints and delivering the intervention online with two classes. Additionally, we conducted small focus groups with students to access their feedback on the intervention. If the data quality from the pilot is poor and the engagement in the lesson is low, we will suspend the trial until schools resume face to face learning and the COVID-19 risk is much lower (e.g., when there is widespread uptake of the vaccine).
- Conditions
- Body Image
- Being tested
- Dove Confident Me Indonesia Single Session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dove Confident Me Indonesia Single SessionBehavioural
Dove Confident Me Indonesia Single Session is an adaptation of Dove Confident Me Global Single Session, designed to be facilitated by schoolteachers or school counsellors. Dove Confident Me Indonesia includes four interactive activities (to be delivered in a single 90-minute session) as well as a homework challenge and commitment pledge. The programme incorporates three primary techniques to improve Indonesian adolescents' body confidence and self-esteem: (1) psychoeducation, (2) media literacy, and (3) cognitive dissonance as well as two secondary techniques: (4) self-affirmation and (5) cognitive reframing. As the curriculum was adapted to be delivered in Indonesian schools with limited resources, videos or PowerPoint presentations are not included. Instead, a detailed teacher guide and student worksheets are provided.
Due to COVID-19, the intervention will be delivered online via video conferencing platform.
| Study group | Role | What they receive |
|---|---|---|
| Dove Confident Me Indonesia - Single Session | Experimental | Dove Confident Me Indonesia Single Session is school-based, body image curriculum. Receives: Behavioral: Dove Confident Me Indonesia Single Session |
| Lessons As Usual Control | No intervention | School lessons as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body esteem
Body esteem will be assessed using the weight and appearance evaluation subscales of the Body Esteem Scale for Adolescents \& Adults (BESAA, Mendelson, Mendelson \& White, 2001). Responses to the 18 items are on a 5-point Likert-type scale. Once the appropriate items are reverse coded, scores will be averaged with higher scores indicating higher body esteem.
Measured: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention).
Secondary outcomes (4)
Change in internalisation of societal appearance ideals
Internalisation of societal appearance ideals will be assessed using the general subscale of the Sociocultural Attitudes Towards Appearance Questionnaire-3 (SATAQ-3; Thompson, Van Den Berg, Roehrig, Guarda, \& Heinberg, 2004). Scores will be averaged with higher scores indicating higher internalisation. Mean score range = 1-5.
Measured: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention).
Change in mood
Positive and negative affect will be measured using the Positive and Negative Affect Schedule (Crawford \& Henry, 2004). Scores on each subscale will be averaged; with higher scores indicating greater negative affect and positive affect respectively. Mean score range for each subscale = 1-5.
Measured: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention).
Change in tendency to engage in appearance comparisons
Two purpose-built items will assess participants' tendency to engage in appearance comparisons. Responses to both items will be on a 5-point Likert-type scale (1=Never to 5=Often). Scores will be averaged with higher scores indicating a greater tendency to engage in appearance comparisons.
Measured: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention).
Skin shade satisfaction
Three purpose-built items will assess participants' satisfaction with their skin shade (i.e., the precise colour of their skin). Responses to the initial two items will be on a 5-point Likert-type scale.
'How dissatisfied or satisfied you are with the colour of your skin?' is rated from 1=very dissatisfied to 5 = very satisfied. 'Which of the following statements do you agree with the most' - 1 = I would like my skin colour to be lighter, 2 = I would like my skin colour to stay the same and 3 = I would like my skin colour to be darker.
The final skin shade satisfaction item will use a visual representation of skin colours (1=darkest skin shade to 9=lightest skin shade). Participants will be asked which skin shade is most alike to their current skin colour, and then which skin shade is closest to their 'ideal' skin colour.
Measured: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Mar 2021
- Primary completion4 Apr 2022
- Study completion1 Jul 2022
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
- Model description
- Two-arm parallel clustered randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,926 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia, University of Hawaii, UNICEF, Unilever R&D
- Responsible party
- Sponsor
- Investigators
- Nadia Craddock, PhD, Principal investigator, Centre for Appearance Research, UWE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665557
- Sponsor's protocol ID
- DSEP_UNICEF_INDO
- Other IDs
- HAS-HSS-18-098
- Status last verified
- Jul 2023
- First submitted
- 29 Sep 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This needs to be a shared decision based on a memorandum of understanding between the University of Indonesia and the University of the West of England. This is not yet finalised.
Publications
Craddock N, Garbett KM, Haywood S, Nasution K, White P, Saraswati LA, Rizkiah C, Medise BE, Diedrichs PC. 'Dove Confident Me Indonesia: Single Session': study protocol for a randomised controlled trial to evaluate a school-based body image intervention among Indonesian adolescents. BMC Public Health. 2021 Nov 16;21(1):2102. doi: 10.1186/s12889-021-11770-0.
PubMed 34784916
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating "Dove Confident Me Indonesia"; A School-Based Single Session Intervention to Improve Body Image and Wellbeing Among Indonesian Adolescents
- ClinicalTrials.gov ID
- NCT04665557
- Acronym / sponsor ID
- DSEP_UNICEF_INDO
- Conditions
- Body Image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,926 participants (actual)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Collaborators
- Universitas Indonesia, University of Hawaii, UNICEF, Unilever R&D
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 11 Dec 2020 (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.
Negative body image is an important public health concern for young people due to its prevalence and detrimental impact on young people's health, education, and social life. Encouragingly, a number of interventions have been designed to improve adolescent body image in school settings, with promising results. However, the vast majority of studies testing these interventions are conducted in high-income, English speaking countries, despite increasingly recognition that negative body image is a global concern. As such, it is important to develop and disseminate interventions to foster positive body image among adolescents in low-to-middle income countries, too.
Research indicates high prevalence rates of negative body image among adolescents in many Asian countries. Indonesia - the focus of the present research - is an emerging middle-income country in South East Asia. A recent U-Report Poll (UNICEF, 2020) found almost 80% of the young people surveyed wanted to change something about their appearance, suggesting a degree of body dissatisfaction and approximately 50% stopped themselves from doing something that was important to them because of appearance concerns. Moreover, according to the same poll, over 90% of Indonesian adolescents surveyed reported to wanting to learn ways to improve their body image in school or online.
To date, no body image interventions have been adapted and trialled in Indonesia. Therefore, this project aims to evaluate the effectiveness as well as the acceptability and feasibility of a specially adapted version of Dove Confident Me Single Session among Indonesian adolescents that will be integrated into UNICEF's Life Skills Education curriculum. Notably, the session has been designed to be feasible to deliver in low-resource schools (e.g., that do not access to the internet or facilities to show videos or PowerPoint slides).
To assess the acceptability, feasibility, and effectiveness of the intervention, the study will compare the body image and well-being of students who take part in the programme to students who do not take part in any programme (classes as usual). Investigators will also gather in-depth feedback from students, and teachers via focus groups and surveys, in order to inform future improvement of the programme for wider implementation.
To undertake this project, the investigators will recruit students and teachers from approximately 10 state junior secondary schools in Indonesia via a local research agency. Students will complete questionnaire assessments of body image and well-being before and after programme period, and again 8 weeks later to assess longer-term benefits.
COVID response: In light of the ongoing pandemic, some research activities will take place online. Decisions on delivery format (online / in-person / hybrid) were made on the basis of continued risk assessments and considerations of local government guidelines.
Detailed description
Detailed COVID Response Description. Though the intervention was specifically designed to be delivered in person and avoided the use of technology to make it accessible to as many Indonesian adolescents as possible, circumstances with COVID-19 have meant that aspects of trial need to be conducted online to minimise undue harm and the spread of infection. Decisions on delivery format were based on regular risk assessments and considerations of local government guidelines. Accordingly, the internal pilot was conducted entirely online as most schools were exclusively offering remote learning and the risk in the area was high. In contrast, shortly following the commencement of the main trial, schools in Surabaya returned to 100% in person teaching (January 2022). Consequently, some research activities, including the lesson, took place in school while sticking to health and safety measures (e.g., social distancing, wearing masks, etc.).
Teacher training will include self-directed learning via UNICEF's teacher training e-module for Life Skills Curriculum which includes the intervention of focus on body image. Teachers will then attend two online training sessions with a member of the research team who is trained in delivering the intervention. These sessions will run through background knowledge about body image, propose how we expect the lesson to look, give the opportunity for teachers to ask questions, and explore common questions/statements from students.
Schools will be recruited for the study via email correspondence from the research agency in Indonesia and information sheets will be sent out to parents/guardians. Parents/guardians will provide informed consent to the school. Students will provide informed consent to the school and during the baseline assessment. Students will complete the surveys across three time points via Qualtrics on personal devices at home or at school. The acceptability focus groups with teachers and students from the intervention condition will take place via a video conferencing platform such as Zoom. The intervention will be delivered online via video conferencing platform.
To ensure this method of the trial is feasible, we need to ensure students have access to a device (laptop or iPad), have a stable internet connection and are familiar with video conferencing platforms for learning. To meet these demands, we will recruit in higher SES areas.
Further, given that we did not initially plan to conduct any aspects of the trial online, we ran an internal acceptability pilot. That is, we tested the feasibility and acceptability of key study elements - i.e., administering the surveys online across three timepoints and delivering the intervention online with two classes. Additionally, we conducted small focus groups with students to access their feedback on the intervention. If the data quality from the pilot is poor and the engagement in the lesson is low, we will suspend the trial until schools resume face to face learning and the COVID-19 risk is much lower (e.g., when there is widespread uptake of the vaccine).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel clustered randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dove Confident Me Indonesia - Single Session | Experimental | Behavioral: Dove Confident Me Indonesia Single SessionDove Confident Me Indonesia Single Session is school-based, body image curriculum. |
| Lessons As Usual Control | No intervention | –School lessons as usual. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- All participating schools must be state junior secondary schools.
- Students in grade 7 through 9 are eligible.
- Students must speak Bahasa Indonesia and must have moderate-high literacy. levels in Bahasa Indonesia - i.e., need to be able to read on their own.
- Students must have access to a device with online access (e.g., laptop or iPad).
Key exclusion criteria (2 listed)
- Non-Bahasa Indonesia speaking students.
- Religious or private schools.
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 |
|---|---|---|
| Dove Confident Me Indonesia Single SessionDove Confident Me Indonesia Single Session is an adaptation of Dove Confident Me Global Single Session, designed to be facilitated by schoolteachers or school counsellors. Dove Confident Me Indonesia includes four interactive activities (to be delivered in a single 90-minute session) as well as a homework challenge and commitment pledge. The programme incorporates three primary techniques to improve Indonesian adolescents' body confidence and self-esteem: (1) psychoeducation, (2) media literacy, and (3) cognitive dissonance as well as two secondary techniques: (4) self-affirmation and (5) cognitive reframing. As the curriculum was adapted to be delivered in Indonesian schools with limited resources, videos or PowerPoint presentations are not included. Instead, a detailed teacher guide and student worksheets are provided. Due to COVID-19, the intervention will be delivered online via video conferencing platform. | Behavioural | Dove Confident Me Indonesia - Single Session |
Primary outcome
Change in body esteem
Time frame: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention).
Body esteem will be assessed using the weight and appearance evaluation subscales of the Body Esteem Scale for Adolescents \& Adults (BESAA, Mendelson, Mendelson \& White, 2001). Responses to the 18 items are on a 5-point Likert-type scale. Once the appropriate items are reverse coded, scores will be averaged with higher scores indicating higher body esteem.
4 secondary outcomes
Change in internalisation of societal appearance ideals
Time frame: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention).
Change in mood
Time frame: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention).
Change in tendency to engage in appearance comparisons
Time frame: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention).
Skin shade satisfaction
Time frame: Baseline; post intervention (1 week after the intervention) and follow-up (8 weeks after the intervention)
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 25 Jul 2023.
- Derived from this study: PubMed 34784916Craddock N, Garbett KM, Haywood S, Nasution K, White P, Saraswati LA, Rizkiah C, Medise BE, Diedrichs PC. 'Dove Confident Me Indonesia: Single Session': study protocol for a randomised controlled trial to evaluate a school-based body image intervention among Indonesian adolescents. BMC Public Health. 2021 Nov 16;21(1):2102. doi: 10.1186/s12889-021-11770-0.
- Individual participant dataSharing planned: Undecided. This needs to be a shared decision based on a memorandum of understanding between the University of Indonesia and the University of the West of England. This is not yet finalised.
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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.
Nadia Craddock, PhD principal investigator
Centre for Appearance Research, UWE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dove Confident Me Indonesia Single Session 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 2 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 25 Jul 2023. 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 week after the intervention) and follow-up (8 weeks after the intervention).). 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 NCT04665557, 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 25 Jul 2023.