Body ImageNCT04587726
Evaluating the Impact of Body Image Edutainment on Adolescent Girls' Body Image
A study testing Girl's room video in people with Body Image and Eating Disorder Symptom, run by University of the West of England at 1 site in United Kingdom.
Trial summary
Body image is one of the leading concerns for young people. These concerns may can have serious consequences, including anxiety, depression, risk taking behaviours, eating disorders and suicidal ideation. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Body Image, Eating Disorder Symptom
- What is being tested?
- Girl's room video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2020to 25 Sep 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 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking and literate
- Instagram/You Tube users
- 12-18 years
- Female north American citizens
- Not participated in academic or market research related to mental health or social media in the preceding 6 months
Who cannot join
- Not Instagram/YouTube users
- Identify as male
- Outside US
- No access to internet/online
- Participated in academic or market research related to mental health or social media in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dove Self-Esteem Project: Evaluating the Impact of Body Image Edutainment on Young People's Body Confidence and Self-esteem
Body image is one of the leading concerns for young people. These concerns may can have serious consequences, including anxiety, depression, risk taking behaviours, eating disorders and suicidal ideation.
An extensive body of research highlights the negative effects associated with viewing idealistic media among adolescents. More recently, research has looked at harnessing media and technology to develop and disseminate material that counteracts these harmful effects. Using 'edutainment' (entertainment with educational content) to develop and disseminate interventions is a novel avenue of research. Micro-interventions (brief, low intensity, self-administered interventions), offer an alternative to traditional, intense interventions that may be unsuitable for milder concerns. Body image micro-interventions have proven effective at providing immediate and short-term improvements in body image among women. To date, body image micro-interventions have been focused on adult samples, with little research exploring how this intervention model may cater to adolescents.
Read more
The aim of the present study is to conduct a randomised controlled trial to evaluate the efficacy of a brief body image video micro-intervention to improve body image and acceptance of appearance diversity among girls, in addition to appearance-related internalised racism among the Black subgroup of girls.
The body image video micro-intervention is a 3-minute episode from Girls Room; a mini-series developed to address risk factors for body image. The series was developed through a collaboration between Lena Waithe, Dove (Unilever) and the Centre for Appearance.
The comparison control group will watch a 3-minute episode from an equivalent popular series which does not contain any appearance-related content.
In addition to the outcomes of interest, post-video acceptability checks will also be assessed to determine viewers' enjoyment, engagement, and identification with the video, as well as their intent to re-engage and share.
To undertake this project, 1848 adolescent girls will be recruited via an external research agency. Female-identifying North American citizens, aged 12-18 years old will be recruited, stratified to include 50% Black and 50% non-Black adolescents. The participants will be randomised to watch either the Girls Room episode, or control episode, at either 25%, 50% or 100% length of exposure. Before watching the video, they will complete baseline measures of demographics, state body satisfaction, acceptance of diversity of appearance, and appearance-related internalised racism (Black girls only). They will then be exposed to the video, before completing the measures again (post-exposure), along with acceptability checks. Participants will then be provided with a debrief of study aims and a list of support sources.
Read the detailed description
Background
Body image is one of the leading concerns for young people. This is particularly concerning, given that body dissatisfaction is a key risk factor for serious mental and physical health issues, including anxiety, depression, risk taking behaviours, eating disorders and suicidal ideation.
An extensive body of research highlights the negative effects associated with viewing idealistic media among adolescents. More recently, research has looked at harnessing media and technology to develop and disseminate material that disrupts and counteracts these harmful effects. 'Edutainment', entertainment with educational content, is an effective method for delivering and modelling health promotion material in mainstream media. Further, it offers an alternative to traditional, intense interventions that are, at times, unnecessary or unsuitable for milder concerns.
Body image micro-interventions have proven effective at providing immediate and short-term improvements in body image among adult women, and research is beginning to explore their impact among young people. A recent study found that evidence-informed body image animations produced immediate and short-term improvements in children's body satisfaction, media literacy, and self-efficacy in addressing appearance teasing. However, these effects were less potent for older children (i.e., adolescents); which may be attributable to the use of cartoons, as opposed to real-life characters. The effects of viewing real-world depictions of positive body image attitudes and behaviours has yet to be evaluated.
In collaboration with Dove (Unilever) and Lena Waithe (an Emmy-Award winning American screenwriter, producer and actress), body image experts from the Centre for Appearance Research (CAR) developed a series of brief videos that depict real-life characters addressing key risk factors for body image concerns.
This study aims to evaluate the acceptability and impact of viewing one 5-minute episode of Girls Room (Episode 1: One of One') on the body image of 13-18-year-old girls from the US. The research questions are as follows:
- Does watching Girls Room result in improved body image and acceptance of diversity of appearance among adolescent girls compared with watching an equivalent series that is popular among adolescent girls and typical of content on Instagram?
- Are these effects moderated by the ethnicity of the viewer (Black versus all other ethnicities)?
- Does watching Girls Room result in reduced appearance-related internalized racism among Black adolescent girls compared with watching an equivalent series that is popular and typical of content on Instagram?
Design
This study adopts an experimental pre-post 2 x 2 design, which includes following two independent variables:
- Ethnicity of viewer (2 Levels) i. Black ii. Non-Black (this will include all other ethnicities expect Black)
- Video condition (2 levels) i. Body image video (Girls Room) ii. Equivalent series that is popular among adolescent girls and typical of content on Instagram (Chicken Girls)
There are three outcome measures (dependent variables) of interest:
- State Body Image (primary outcome)
- State Acceptance of Diversity of Appearance (secondary outcome)
- State Appearance-related Internalized Racism- to be measured among Black girls only (secondary outcome)
There is also one moderator:
- Ethnicity of the viewer (Black vs. Non-Black)
Participants \& Recruitment
The current content is aimed at improving body image risk factors and increasing knowledge and protective factors prevalent amongst adolescent girls. Therefore, the research will utilise a representative sample of North American girls aged 12-18 years old. They will be stratified to be 50% Black and 50% other ethnicities, who are current users of Instagram or YouTube.
To achieve the agreed upon research objectives and in alignment with project timelines, the recruitment process will be out-sourced to an external professional recruitment agency. The agency's brief will outline the following inclusion criteria; female North American citizens, aged 12-18 years old; English speaking, not participated in academic or market research elated to mental health or social media in the preceding 6 months. Participants will be offered agency credit for their participation.
A sample size of 640 (160 girls per cell) is necessary for 80% power to detect a partial eta squared as low as 0.012, and based on the assumption that there will be a correlation between Time 1 (pre) and Time 2 (post) measures of 0.5.
Intervention
Girls Room, a body image mini-series, was developed in collaboration with Lena Waithe, Dove and CAR. Video content was informed by empirical evidence related to body image prevention and intervention. The series consists of five, 3-minute videos, with each video targeting a key risk factor for body image (see below). The five videos aired on Instagram TV (IGTV) in March 2020.
Procedure
Girls will not be briefed on the purpose of the study, the research questions, or their condition prior to or during study participation. However, they will be given sufficient information to provide informed consent. They will also be advised that they may be asked the same questions twice throughout the study. After completing the study, participants should be fully debriefed and provided with sources of support.
The online study will include validated, age-appropriate, self-report measures that assess demographics and the immediate impact of video exposure on adolescents' body image and associated risk and protective factors. Outcome assessments will be conducted at two time points, including immediately before (time one) and after video exposure (time two). Assessments and video exposure will occur within one session. The survey will be conducted online, at home, and should take no longer than 25 minutes for participants to complete.
Recruitment and survey dissemination will be conducted by a third-party research agency. The agency will contact eligible participants via their parents, with consent required by both parent and child. Following consent, the child will participate in a once-off survey that consists of four phases:
- Baseline assessments of demographics, body image, acceptance of appearance diversity, internalised racism (Black participants only)
- Randomisation into exposure condition
- Video exposure
- Post-exposure assessments of body image, acceptance of appearance diversity, internalised racism (Black participants only), acceptability checks (Enjoyment, Engagement, and Identification, Re-engagement, and Sharing)
Participants will then be provided with a debrief of study aims and a list of support sources.
- Conditions
- Body Image, Eating Disorder Symptom
- Being tested
- Girl's room video, Control video - Chicken Girls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Girl's room videoBehavioural
Girls Room, a body image mini-series, developed in collaboration with Lena Waithe, Dove and CAR.
Video content was informed by empirical evidence related to body image prevention and intervention. The series consists of five, 3-minute videos.
The videos follow the lives of a 5 best friends, and each video targets a key risk factor for body image:
- Appearance comparison
- Body appreciation
- Body talk
- Body functionality
- Appearance teasing \& bullying
- Appearance focus
The five videos aired on Instagram TV (IGTV) in March 2020.
Control video - Chicken GirlsOther
Chicken Girl's Episode - appearance neutral episode matched for target audience and video length
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Girl's room video |
| Control Group | Active comparator | Not described Receives: Other: Control video - Chicken Girls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State body satisfaction
Measured via Visual Analogue Scales (Richardson \& Paxton, 2010; McLean, Paxton \& Wetherheim, 2016). 6-items for the measure, VAS scales (min 0 max 100), along with 12 filler items and 4 attention checks.
Measured: Immediately pre-intervention and immediately post-intervention (change)
Secondary outcomes (3)
Change in Acceptance of appearance diversity
Adapted measure (based on Masnari et al., 2013; Parnell et al., under review; Matheson et al., in press). 4 different characters are shown, with 9-items for each presented on a VAS scale (opposite anchors e.g. mean-nice, sad-happy, unpopular-popular) , as well as attention checks throughout (every 3 items).
Measured: Immediately pre-intervention and immediately post-intervention (change)
Change in Internalised Racism (Black sample only)
Measured via VAS scales adapted from the Alteration of Physical Appearance (APA) and Hair Change (HC) subscales of the Internalized Racial Oppression Scale for Black Individuals (Bailey et al., 2011). 3 of the 8 items are removed as they refer to behaviours/perceptions of others, rather than attitudes about their own appearance. Attention checks are included every 4th item
Measured: Immediately pre-intervention and immediately post-intervention (change)
Intervention acceptability
Measured on 12 VAS scales (min 0, max 100), assessing enjoyment, engagement, identification, and intent to re-engage and share. 2 attention checks are included.
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start6 Oct 2020
- Primary completion28 May 2021
- Study completion25 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Collaborators
- Unilever R&D
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587726
- Sponsor's protocol ID
- 6423321
- Status last verified
- Aug 2022
- First submitted
- 23 Sep 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dove Self-Esteem Project: Evaluating the Impact of Body Image Edutainment on Young People's Body Confidence and Self-esteem
- ClinicalTrials.gov ID
- NCT04587726
- Acronym / sponsor ID
- 6423321
- Conditions
- Body Image, Eating Disorder Symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Collaborators
- Unilever R&D
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 14 Oct 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.
Body image is one of the leading concerns for young people. These concerns may can have serious consequences, including anxiety, depression, risk taking behaviours, eating disorders and suicidal ideation.
An extensive body of research highlights the negative effects associated with viewing idealistic media among adolescents. More recently, research has looked at harnessing media and technology to develop and disseminate material that counteracts these harmful effects. Using 'edutainment' (entertainment with educational content) to develop and disseminate interventions is a novel avenue of research. Micro-interventions (brief, low intensity, self-administered interventions), offer an alternative to traditional, intense interventions that may be unsuitable for milder concerns. Body image micro-interventions have proven effective at providing immediate and short-term improvements in body image among women. To date, body image micro-interventions have been focused on adult samples, with little research exploring how this intervention model may cater to adolescents.
The aim of the present study is to conduct a randomised controlled trial to evaluate the efficacy of a brief body image video micro-intervention to improve body image and acceptance of appearance diversity among girls, in addition to appearance-related internalised racism among the Black subgroup of girls.
The body image video micro-intervention is a 3-minute episode from Girls Room; a mini-series developed to address risk factors for body image. The series was developed through a collaboration between Lena Waithe, Dove (Unilever) and the Centre for Appearance.
The comparison control group will watch a 3-minute episode from an equivalent popular series which does not contain any appearance-related content.
In addition to the outcomes of interest, post-video acceptability checks will also be assessed to determine viewers' enjoyment, engagement, and identification with the video, as well as their intent to re-engage and share.
To undertake this project, 1848 adolescent girls will be recruited via an external research agency. Female-identifying North American citizens, aged 12-18 years old will be recruited, stratified to include 50% Black and 50% non-Black adolescents. The participants will be randomised to watch either the Girls Room episode, or control episode, at either 25%, 50% or 100% length of exposure. Before watching the video, they will complete baseline measures of demographics, state body satisfaction, acceptance of diversity of appearance, and appearance-related internalised racism (Black girls only). They will then be exposed to the video, before completing the measures again (post-exposure), along with acceptability checks. Participants will then be provided with a debrief of study aims and a list of support sources.
Detailed description
Background
Body image is one of the leading concerns for young people. This is particularly concerning, given that body dissatisfaction is a key risk factor for serious mental and physical health issues, including anxiety, depression, risk taking behaviours, eating disorders and suicidal ideation.
An extensive body of research highlights the negative effects associated with viewing idealistic media among adolescents. More recently, research has looked at harnessing media and technology to develop and disseminate material that disrupts and counteracts these harmful effects. 'Edutainment', entertainment with educational content, is an effective method for delivering and modelling health promotion material in mainstream media. Further, it offers an alternative to traditional, intense interventions that are, at times, unnecessary or unsuitable for milder concerns.
Body image micro-interventions have proven effective at providing immediate and short-term improvements in body image among adult women, and research is beginning to explore their impact among young people. A recent study found that evidence-informed body image animations produced immediate and short-term improvements in children's body satisfaction, media literacy, and self-efficacy in addressing appearance teasing. However, these effects were less potent for older children (i.e., adolescents); which may be attributable to the use of cartoons, as opposed to real-life characters. The effects of viewing real-world depictions of positive body image attitudes and behaviours has yet to be evaluated.
In collaboration with Dove (Unilever) and Lena Waithe (an Emmy-Award winning American screenwriter, producer and actress), body image experts from the Centre for Appearance Research (CAR) developed a series of brief videos that depict real-life characters addressing key risk factors for body image concerns.
This study aims to evaluate the acceptability and impact of viewing one 5-minute episode of Girls Room (Episode 1: One of One') on the body image of 13-18-year-old girls from the US. The research questions are as follows:
- Does watching Girls Room result in improved body image and acceptance of diversity of appearance among adolescent girls compared with watching an equivalent series that is popular among adolescent girls and typical of content on Instagram?
- Are these effects moderated by the ethnicity of the viewer (Black versus all other ethnicities)?
- Does watching Girls Room result in reduced appearance-related internalized racism among Black adolescent girls compared with watching an equivalent series that is popular and typical of content on Instagram?
Design
This study adopts an experimental pre-post 2 x 2 design, which includes following two independent variables:
- Ethnicity of viewer (2 Levels) i. Black ii. Non-Black (this will include all other ethnicities expect Black)
- Video condition (2 levels) i. Body image video (Girls Room) ii. Equivalent series that is popular among adolescent girls and typical of content on Instagram (Chicken Girls)
There are three outcome measures (dependent variables) of interest:
- State Body Image (primary outcome)
- State Acceptance of Diversity of Appearance (secondary outcome)
- State Appearance-related Internalized Racism- to be measured among Black girls only (secondary outcome)
There is also one moderator:
- Ethnicity of the viewer (Black vs. Non-Black)
Participants \& Recruitment
The current content is aimed at improving body image risk factors and increasing knowledge and protective factors prevalent amongst adolescent girls. Therefore, the research will utilise a representative sample of North American girls aged 12-18 years old. They will be stratified to be 50% Black and 50% other ethnicities, who are current users of Instagram or YouTube.
To achieve the agreed upon research objectives and in alignment with project timelines, the recruitment process will be out-sourced to an external professional recruitment agency. The agency's brief will outline the following inclusion criteria; female North American citizens, aged 12-18 years old; English speaking, not participated in academic or market research elated to mental health or social media in the preceding 6 months. Participants will be offered agency credit for their participation.
A sample size of 640 (160 girls per cell) is necessary for 80% power to detect a partial eta squared as low as 0.012, and based on the assumption that there will be a correlation between Time 1 (pre) and Time 2 (post) measures of 0.5.
Intervention
Girls Room, a body image mini-series, was developed in collaboration with Lena Waithe, Dove and CAR. Video content was informed by empirical evidence related to body image prevention and intervention. The series consists of five, 3-minute videos, with each video targeting a key risk factor for body image (see below). The five videos aired on Instagram TV (IGTV) in March 2020.
Procedure
Girls will not be briefed on the purpose of the study, the research questions, or their condition prior to or during study participation. However, they will be given sufficient information to provide informed consent. They will also be advised that they may be asked the same questions twice throughout the study. After completing the study, participants should be fully debriefed and provided with sources of support.
The online study will include validated, age-appropriate, self-report measures that assess demographics and the immediate impact of video exposure on adolescents' body image and associated risk and protective factors. Outcome assessments will be conducted at two time points, including immediately before (time one) and after video exposure (time two). Assessments and video exposure will occur within one session. The survey will be conducted online, at home, and should take no longer than 25 minutes for participants to complete.
Recruitment and survey dissemination will be conducted by a third-party research agency. The agency will contact eligible participants via their parents, with consent required by both parent and child. Following consent, the child will participate in a once-off survey that consists of four phases:
- Baseline assessments of demographics, body image, acceptance of appearance diversity, internalised racism (Black participants only)
- Randomisation into exposure condition
- Video exposure
- Post-exposure assessments of body image, acceptance of appearance diversity, internalised racism (Black participants only), acceptability checks (Enjoyment, Engagement, and Identification, Re-engagement, and Sharing)
Participants will then be provided with a debrief of study aims and a list of support sources.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Girl's room video |
| Control Group | Active comparator | Other: Control video - Chicken Girls |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- English speaking and literate
- Instagram/You Tube users
- 12-18 years
- Female north American citizens
- Not participated in academic or market research related to mental health or social media in the preceding 6 months
Key exclusion criteria (5 listed)
- Not Instagram/YouTube users
- Identify as male
- Outside US
- No access to internet/online
- Participated in academic or market research related to mental health or social media in the past 6 months
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 |
|---|---|---|
| Girl's room videoGirls Room, a body image mini-series, developed in collaboration with Lena Waithe, Dove and CAR. Video content was informed by empirical evidence related to body image prevention and intervention. The series consists of five, 3-minute videos. The videos follow the lives of a 5 best friends, and each video targets a key risk factor for body image: 1. Appearance comparison 2. Body appreciation 3. Body talk 4. Body functionality 5. Appearance teasing \& bullying 6. Appearance focus The five videos aired on Instagram TV (IGTV) in March 2020. | Behavioural | Intervention Group |
| Control video - Chicken GirlsChicken Girl's Episode - appearance neutral episode matched for target audience and video length | Other | Control Group |
Primary outcome
Change in State body satisfaction
Time frame: Immediately pre-intervention and immediately post-intervention (change)
Measured via Visual Analogue Scales (Richardson \& Paxton, 2010; McLean, Paxton \& Wetherheim, 2016). 6-items for the measure, VAS scales (min 0 max 100), along with 12 filler items and 4 attention checks.
3 secondary outcomes
Change in Acceptance of appearance diversity
Time frame: Immediately pre-intervention and immediately post-intervention (change)
Change in Internalised Racism (Black sample only)
Time frame: Immediately pre-intervention and immediately post-intervention (change)
Intervention acceptability
Time frame: Immediately post-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 4 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Body Image
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingObservational study
Glucose Levels and Outcomes in Women - Mid Pregnancy
Pregnancy
Enrolling by invitation
Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
Hyperkyphosis, Adolescent
Not yet recruiting
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.
Eating Disorders, Body Image Dissatisfaction
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Girl's room video in people with Body Image and Eating Disorder Symptom, 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 5 inclusion and 5 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 4 Aug 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 State body satisfaction (time frame: Immediately pre-intervention and immediately post-intervention (change)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2022.