Body ImageEarly Phase 1NCT06546241
Celebrandome: Preliminary Study
A Early Phase 1 study testing Celebrandome in people with Body Image and Self Esteem, run by Arizona State University at 1 site in United States.
Trial summary
The Dove Self Esteem Project, has provided our research team with funding to develop a 60- minute workshop for Hispanic/Latinx Youth between the ages of 11 to 16 years old that builds body confidence. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Image, Self Esteem
- What is being tested?
- Celebrandome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 31 Dec 2023
- Phase
- Early Phase 1
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth who are 11 to 16 years of age
- Youth who identify as Hispanic/Latino/Latinx
- Youth who are fluent in English
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Celebrándome: A Body Confidence Program for Hispanic/Latinx Youth
The Dove Self Esteem Project, has provided our research team with funding to develop a 60- minute workshop for Hispanic/Latinx Youth between the ages of 11 to 16 years old that builds body confidence. This workshop was developed based on prior curriculum the investigator has developed for The Dove Self Esteem Project and designed with two teachers and several adolescent children.
The aims of the current study are to: 1) examine the efficacy of the workshop, and 2.) evaluate the extent to which children like the curriculum and find it useful. Children will be randomized to control group or intervention group; however, the control group will eventually go through the workshop after 2 surveys. It is hypothesized that children in the intervention group will report higher body satisfaction scores, greater self- esteem, more awareness of body talk and less engagement in appearance comparisons relative to the control group. It is hypothesized that children will report liking the workshop, finding it useful and engaging.
- Conditions
- Body Image, Self Esteem
- Being tested
- Celebrandome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelebrandomeBehavioural
Also called Body Confidence Single Session
This intervention is based on existing cognitive dissonance body confidence programs for youth such as Amazing Me, Free Being Me, and Body Project. Consistent with these programs, workshops are entirely experiential getting you to discuss appearance ideals and why they are problematic, pressures they experience to conform to appearance ideals, ways to combat pressures, they compare pictures that are normal versus digitally altered and discuss ways this is problematic, they discuss body talk statements they hear all the time and how this promotes appearance ideals, they practice ways to combat body talk statements. They develop positive affirmation statements. In addition and unique to this curriculum, all activities highlight cultural ideals and how youth can receive different messages related to different appearance ideals and they unique stress and pressures this creates.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Hispanic/Latinx youth between the ages of 11 to 16 will participate in a 60 minute workshop aimed and increasing body image satisfaction and self esteem. Participants randomized to the intervention group are scheduled immediately to receive the intervention. The intervention is delivered in a group format with groups consisting of no more than 20 youth. Receives: Behavioral: Celebrandome |
| Wait-List Control Group | No intervention | The control group is a waitlist control group. Participants in the control group complete a survey, wait for 2 to 3 weeks, then are eligible to sign up for the workshop. During the wait-list period they complete 2 surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline - Body Image Self Esteem (Body Esteem Scale; Mendelson & White, 1982)
This measure assesses the extent youth like their appearance and the extent they dislike their appearance. Higher scores indicate more self esteem. Instructions are "Right now, please tell us how much this represents you." Items are on a Likert scale from 0 (never) to 4 (Always).
Measured: This measure is administered immediately before the intervention.
Post - Body Image Self Esteem (Body Esteem Scale; Mendelson & White, 1982)
This measure assesses the extent youth like their appearance and the extent they dislike their appearance. Higher scores indicate more self esteem. Instructions are "Right now, please tell us how much this represents you." Items are on a Likert scale from 0 (never) to 4 (Always).
Measured: This measure is administered immediately after the intervention.
Baseline - General Self Esteem (Rosenberg Self-Esteem Scale - Child Version; -Rosenberg, 1965)
This measure assesses the extent to which a person like themselves or feels competent. Higher scores indicate more higher self esteem. Instructions are "Right now, please tell us how much this represents you." Items are on a Likert scale from 0 (I strongly agree ) to 3 (I strongly disagree).
Measured: This measure is administered immediately before the intervention.
Post - General Self Esteem (Rosenberg Self-Esteem Scale - Child Version; Rosenberg, 1965)
This measure assesses the extent to which a person like themselves or feels competent. Higher scores indicate more higher self esteem. Instructions are "Right now, please tell us how much this represents you." Items are on a Likert scale from 0 (I strongly agree ) to 3 (I strongly disagree).
Measured: This measure is administered immediately after the intervention.
Secondary outcomes (6)
Baseline - Appearance Conversations Scale (Jones, Vigfusdottir, & Lee, 2004).
This measure assesses the extent a youth talks about appearance with friends. Instructions are "how often do you talk about the following things with your friends?" Items are on a Likert scale form 0 (never) to 4 (very often), with higher scores indicating higher frequency of engaging in appearance conversations.
Measured: This measure is administered immediately before the intervention.
Post - Appearance Conversations Scale (Jones, Vigfusdottir, & Lee, 2004).
This measure assesses the extent a youth talks about appearance with friends. Instructions are "how often do you talk about the following things with your friends?" Items are on a Likert scale form 0 (never) to 4 (very often), with higher scores indicating higher frequency of engaging in appearance conversations.
Measured: This measure is administered immediately after the intervention.
Baseline - Pressures to Conform to Appearance Ideals (Sociocultural Pressures Scale; Diedrichs, Atkinson, Steer, 2015)
Assesses how often children feel pressure from friends, family or the media to change different aspects of their appearance. Instructions are "please circle how often you do this..." Items are on a Likert scale from 0 (none) to 4 (a lot), with higher scores indicating more feeling more pressure.
Measured: This measure is administered immediately before the intervention.
Post - Pressures to Conform to Appearance Ideals (Sociocultural Pressures Scale; Diedrichs, Atkinson, Steer, 2015)
Assesses how often children feel pressure from friends, family or the media to change different aspects of their appearance. Instructions are "please circle how often you do this..." Items are on a Likert scale from 0 (none) to 4 (a lot), with higher scores indicating more feeling more pressure.
Measured: This measure is administered immediately after the intervention.
Baseline - Appearance Comparisons (Social Comparison to Models and Peers Scale; Jones, 2001)
Assesses how often children compare themselves to kids their age or celebrities/people in the media. Instructions are "lease circle how often you do this..." Items are on a Likert scale from 0 (never) to 4 (a lot), with higher scores indicating more engagement in appearance comparisons.
Measured: This measure is administered immediately before the intervention.
Post - Appearance Comparisons (Social Comparison to Models and Peers Scale; Jones, 2001)
Assesses how often children compare themselves to kids their age or celebrities/people in the media. Instructions are "lease circle how often you do this..." Items are on a Likert scale from 0 (never) to 4 (a lot), with higher scores indicating more engagement in appearance comparisons.
Measured: This measure is administered immediately 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 posted9 Aug 2024
- Study start26 Apr 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to the intervention or wait-list control group. The intervention group will complete a baseline survey, receive the 60 minute workshop, and completes a post-intervention survey. The control group receives a survey, waits, completes a baseline survey, then receives the 60 minute workshop, and completes a post-intervention survey.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Dove Self Esteem Project, Unilever Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546241
- Sponsor's protocol ID
- STUDY00017437
- Status last verified
- Aug 2024
- First submitted
- 30 Mar 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pending IRB approval, researchers can contact the PI to obtain the de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celebrándome: A Body Confidence Program for Hispanic/Latinx Youth
- ClinicalTrials.gov ID
- NCT06546241
- Acronym / sponsor ID
- STUDY00017437
- Conditions
- Body Image, Self Esteem
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Dove Self Esteem Project, Unilever Inc
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Aug 2024 (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 Dove Self Esteem Project, has provided our research team with funding to develop a 60- minute workshop for Hispanic/Latinx Youth between the ages of 11 to 16 years old that builds body confidence. This workshop was developed based on prior curriculum the investigator has developed for The Dove Self Esteem Project and designed with two teachers and several adolescent children.
The aims of the current study are to: 1) examine the efficacy of the workshop, and 2.) evaluate the extent to which children like the curriculum and find it useful. Children will be randomized to control group or intervention group; however, the control group will eventually go through the workshop after 2 surveys. It is hypothesized that children in the intervention group will report higher body satisfaction scores, greater self- esteem, more awareness of body talk and less engagement in appearance comparisons relative to the control group. It is hypothesized that children will report liking the workshop, finding it useful and engaging.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized to the intervention or wait-list control group. The intervention group will complete a baseline survey, receive the 60 minute workshop, and completes a post-intervention survey. The control group receives a survey, waits, completes a baseline survey, then receives the 60 minute workshop, and completes a post-intervention survey.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: CelebrandomeHispanic/Latinx youth between the ages of 11 to 16 will participate in a 60 minute workshop aimed and increasing body image satisfaction and self esteem. Participants randomized to the intervention group are scheduled immediately to receive the intervention. The intervention is delivered in a group format with groups consisting of no more than 20 youth. |
| Wait-List Control Group | No intervention | –The control group is a waitlist control group. Participants in the control group complete a survey, wait for 2 to 3 weeks, then are eligible to sign up for the workshop. During the wait-list period they complete 2 surveys. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Youth who are 11 to 16 years of age
- Youth who identify as Hispanic/Latino/Latinx
- Youth who are fluent in English
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| CelebrandomeAlso: Body Confidence Single SessionThis intervention is based on existing cognitive dissonance body confidence programs for youth such as Amazing Me, Free Being Me, and Body Project. Consistent with these programs, workshops are entirely experiential getting you to discuss appearance ideals and why they are problematic, pressures they experience to conform to appearance ideals, ways to combat pressures, they compare pictures that are normal versus digitally altered and discuss ways this is problematic, they discuss body talk statements they hear all the time and how this promotes appearance ideals, they practice ways to combat body talk statements. They develop positive affirmation statements. In addition and unique to this curriculum, all activities highlight cultural ideals and how youth can receive different messages related to different appearance ideals and they unique stress and pressures this creates. | Behavioural | Intervention Group |
Primary outcome
Baseline - Body Image Self Esteem (Body Esteem Scale; Mendelson & White, 1982)
Time frame: This measure is administered immediately before the intervention.
This measure assesses the extent youth like their appearance and the extent they dislike their appearance. Higher scores indicate more self esteem. Instructions are "Right now, please tell us how much this represents you." Items are on a Likert scale from 0 (never) to 4 (Always).
Post - Body Image Self Esteem (Body Esteem Scale; Mendelson & White, 1982)
Time frame: This measure is administered immediately after the intervention.
This measure assesses the extent youth like their appearance and the extent they dislike their appearance. Higher scores indicate more self esteem. Instructions are "Right now, please tell us how much this represents you." Items are on a Likert scale from 0 (never) to 4 (Always).
Baseline - General Self Esteem (Rosenberg Self-Esteem Scale - Child Version; -Rosenberg, 1965)
Time frame: This measure is administered immediately before the intervention.
This measure assesses the extent to which a person like themselves or feels competent. Higher scores indicate more higher self esteem. Instructions are "Right now, please tell us how much this represents you." Items are on a Likert scale from 0 (I strongly agree ) to 3 (I strongly disagree).
Post - General Self Esteem (Rosenberg Self-Esteem Scale - Child Version; Rosenberg, 1965)
Time frame: This measure is administered immediately after the intervention.
This measure assesses the extent to which a person like themselves or feels competent. Higher scores indicate more higher self esteem. Instructions are "Right now, please tell us how much this represents you." Items are on a Likert scale from 0 (I strongly agree ) to 3 (I strongly disagree).
6 secondary outcomes
Baseline - Appearance Conversations Scale (Jones, Vigfusdottir, & Lee, 2004).
Time frame: This measure is administered immediately before the intervention.
Post - Appearance Conversations Scale (Jones, Vigfusdottir, & Lee, 2004).
Time frame: This measure is administered immediately after the intervention.
Baseline - Pressures to Conform to Appearance Ideals (Sociocultural Pressures Scale; Diedrichs, Atkinson, Steer, 2015)
Time frame: This measure is administered immediately before the intervention.
Post - Pressures to Conform to Appearance Ideals (Sociocultural Pressures Scale; Diedrichs, Atkinson, Steer, 2015)
Time frame: This measure is administered immediately after the intervention.
Baseline - Appearance Comparisons (Social Comparison to Models and Peers Scale; Jones, 2001)
Time frame: This measure is administered immediately before the intervention.
Post - Appearance Comparisons (Social Comparison to Models and Peers Scale; Jones, 2001)
Time frame: This measure is administered immediately 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 9 Aug 2024.
- Individual participant dataSharing planned: No. Pending IRB approval, researchers can contact the PI to obtain the de-identified data.
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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.
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 Early Phase 1 study testing Celebrandome in people with Body Image and Self Esteem, run by Arizona State University at 1 site in United States.
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 3 inclusion and 1 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 9 Aug 2024. 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 States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Baseline - Body Image Self Esteem (Body Esteem Scale; Mendelson & White, 1982) (time frame: This measure is administered immediately before the intervention.). The study lists 4 primary outcomes in all. 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 9 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.