Wait List ControlNCT07189559
School-Based Body Image Concerns Prevention
A study testing Digital Bodies in people with Wait List Control and Intervention Program, run by Villa Garda Hospital at 1 site in Italy.
Trial summary
The present study, sought to adapt Digital Bodies (a single-session intervention promoted in the United Kingdom (Bell et al., 2022) for the Italian school context and to assess its effectiveness as a single-session intervention aimed at challenging unrealistic appearance ideals and appearance-related pressures within… Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Wait List Control, Intervention Program
- What is being tested?
- Digital Bodies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteItaly
- Study dates
- 6 Nov 2024to 29 May 2025
- 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- First or second year of upper secondary school
Who cannot join
- They and their parents did not provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Bodies: A Brief Intervention in Secondary Schools to Reduce Negative Body Image Among Adolescents in the Digital Age
The present study, sought to adapt Digital Bodies (a single-session intervention promoted in the United Kingdom (Bell et al., 2022) for the Italian school context and to assess its effectiveness as a single-session intervention aimed at challenging unrealistic appearance ideals and appearance-related pressures within social media environments. The study includes a cluster randomized controlled trial with two assessment points (baseline, post-intervention and 8-week follow-up) comparing the "Digital Bodies" program to a no-intervention control group. To ensure that all students benefit from the intervention, the control group received the intervention after the 8 weeks.
Read the detailed description
The investigators conducted a cluster randomized controlled trial with two assessment points (baseline, post-intervention and 8-week follow-up) comparing the "Digital Bodies" program to a no-intervention control group. To ensure that all students benefit from the intervention, the control group received the intervention after the 8 weeks.
Randomization was performed at the school level, not the student level. This is known as cluster randomization, and it aims to avoid "contamination effects" (Smolak \& Levine, 2001).
The research protocol was approved by the GHC Institutional Review Board (Protocol No. 0025GHCIRB). Written informed consent was obtained from each participant and their parent(s) or legal guardian(s), authorizing the collection and anonymized use of data for research purposes.
Participants Four hundred and forty-nine eligible participants were recruited from December 2024 to May 2025. Secondary school administrators were approached either by phone or email and received an information letter describing the key elements of the prevention program. Participation required the school principal-or a designated representative-to provide written confirmation through a signed agreement. Eligible participants were students in their first or second year of upper secondary school who, along with their parents, provided written informed consent. Students who did not complete the baseline questionnaire and the case report form were excluded from the analysis but were still permitted to participate in the intervention itself.
The "Digital Bodies" Program and Study Implementation The Digital Bodies intervention, adapted from an English study that demonstrated its effectiveness (Bell et al., 2022), consists of a one-hour interactive session. The session begins with a brief self-affirmation exercise, in which participants are asked to describe something important to them and explain why. When used at the start of the intervention, this technique can help reduce participants' initial resistance to health-promotion messages.
The core of the intervention involves the use of cognitive dissonance techniques and the development of critical literacy skills to encourage adolescents to critically reflect on appearance ideals, as well as to foster the skills needed to challenge such ideals.
The content focuses on (i) the socially constructed nature of body ideals across time and culture, with particular attention to social media spaces, (ii) the deconstruction of myths surrounding the "perfect body" (e.g., image editing, idealization), again with a focus on social media environments, and (iii) the role of adolescents in creating, perpetuating, and reinforcing these ideals through digital technologies, including social media.
The session concludes with an implementation-intentions exercise, where participants develop specific behavioral plans describing how they would act in three situations in which appearance ideals are most salient, to challenge or resist them.
- Conditions
- Wait List Control, Intervention Program
- Being tested
- Digital Bodies
- Keywords
- school-based intervention, adolescents, unrealistic appearance ideals, social media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital BodiesBehavioural
The Digital Bodies intervention consists of a one-hour interactive session. The core of the intervention involves the use of cognitive dissonance techniques and the development of critical literacy skills to encourage adolescents to critically reflect on appearance ideals, as well as to foster the skills needed to challenge such ideals.
| Study group | Role | What they receive |
|---|---|---|
| Digital Bodies intervention | Experimental | The Digital Bodies intervention consists of a one-hour interactive session. The session begins with a brief self-affirmation exercise, in which participants are asked to describe something important to them and explain why.
The core of the intervention involves the use of cognitive dissonance techniques and the development of critical literacy skills to encourage adolescents to critically reflect on appearance ideals, as well as to foster the skills needed to challenge such ideals.
The content focuses on (i) the socially constructed nature of body ideals across time and culture, with particular attention to social media spaces, (ii) the deconstruction of myths surrounding the "perfect body" (e.g., image editing, idealization), again with a focus on social media environments, and (iii) the role of adolescents in creating, perpetuating, and reinforcing these ideals through digital technologies, including social media. Receives: Behavioral: Digital Bodies |
| Waitlist control | No intervention | No-intervention control group. To ensure that all students benefit from the intervention, the control group received the intervention after the 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Satisfaction
Body satisfaction was measured using the Body Satisfaction Scale (BSS) (Bird et al., 2013). The scale comprises five items (e.g., "Do you feel satisfied with your appearance?"), rated on a 5-point Likert scale (1 = never, 5 = very often). Total scores range from 1 to 25, with higher values indicating greater body satisfaction. The items were translated into Italian and back-translated by a professional bilingual.
Measured: Basal, post.treatment, 8-week follow-up
Internalization of Appearance Ideals
Internalization of appearance ideals was assessed using the Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ-4R). The SATAQ-4R, in both its male and female forms, consists of seven conceptually coherent subscales. Three of these capture aspects of internalization. The remaining four subscales assess perceived sociocultural pressures: from family, peers, significant others, and the media.
Each item is rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores indicate higher perceived sociocultural pressures
Measured: Basal, post-intervention, 8-week follow-up
Self-Objectification
Self-objectification was evaluated with the Likert Self-Objectification Questionnaire (LSOQ) (Wollast et al., 2021). Participants ranked 10 body attributes according to their importance for self-concept (1 = not at all important, 11 = very important). Five attributes reflect appearance (e.g., sexual appeal, physical attractiveness), while five reflect competence (e.g., health, strength). Scores are calculated by subtracting the sum of the appearance attributes from the sum of the competence attributes (range= -25 to 25). Higher scores reflect a greater emphasis on the importance of appearance-based physical attributes over competency-based attributes, that is, high levels of self-objectification.
Measured: Basal, post-intervention, 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start6 Nov 2024
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wait List ControlStudies 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
- Intervention vs no intervention
- Masking
- None (open label)
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Garda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Dalle Grave, Villa Garda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189559
- Sponsor's protocol ID
- D.BODY/2025
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 2 Oct 2025
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Bodies: A Brief Intervention in Secondary Schools to Reduce Negative Body Image Among Adolescents in the Digital Age
- ClinicalTrials.gov ID
- NCT07189559
- Acronym / sponsor ID
- D.BODY/2025
- Conditions
- Wait List Control, Intervention Program
- Keywords
- school-based intervention, adolescents, unrealistic appearance ideals, social media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- Villa Garda HospitalUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 24 Sep 2025 (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 present study, sought to adapt Digital Bodies (a single-session intervention promoted in the United Kingdom (Bell et al., 2022) for the Italian school context and to assess its effectiveness as a single-session intervention aimed at challenging unrealistic appearance ideals and appearance-related pressures within social media environments. The study includes a cluster randomized controlled trial with two assessment points (baseline, post-intervention and 8-week follow-up) comparing the "Digital Bodies" program to a no-intervention control group. To ensure that all students benefit from the intervention, the control group received the intervention after the 8 weeks.
Detailed description
The investigators conducted a cluster randomized controlled trial with two assessment points (baseline, post-intervention and 8-week follow-up) comparing the "Digital Bodies" program to a no-intervention control group. To ensure that all students benefit from the intervention, the control group received the intervention after the 8 weeks.
Randomization was performed at the school level, not the student level. This is known as cluster randomization, and it aims to avoid "contamination effects" (Smolak \& Levine, 2001).
The research protocol was approved by the GHC Institutional Review Board (Protocol No. 0025GHCIRB). Written informed consent was obtained from each participant and their parent(s) or legal guardian(s), authorizing the collection and anonymized use of data for research purposes.
Participants Four hundred and forty-nine eligible participants were recruited from December 2024 to May 2025. Secondary school administrators were approached either by phone or email and received an information letter describing the key elements of the prevention program. Participation required the school principal-or a designated representative-to provide written confirmation through a signed agreement. Eligible participants were students in their first or second year of upper secondary school who, along with their parents, provided written informed consent. Students who did not complete the baseline questionnaire and the case report form were excluded from the analysis but were still permitted to participate in the intervention itself.
The "Digital Bodies" Program and Study Implementation The Digital Bodies intervention, adapted from an English study that demonstrated its effectiveness (Bell et al., 2022), consists of a one-hour interactive session. The session begins with a brief self-affirmation exercise, in which participants are asked to describe something important to them and explain why. When used at the start of the intervention, this technique can help reduce participants' initial resistance to health-promotion messages.
The core of the intervention involves the use of cognitive dissonance techniques and the development of critical literacy skills to encourage adolescents to critically reflect on appearance ideals, as well as to foster the skills needed to challenge such ideals.
The content focuses on (i) the socially constructed nature of body ideals across time and culture, with particular attention to social media spaces, (ii) the deconstruction of myths surrounding the "perfect body" (e.g., image editing, idealization), again with a focus on social media environments, and (iii) the role of adolescents in creating, perpetuating, and reinforcing these ideals through digital technologies, including social media.
The session concludes with an implementation-intentions exercise, where participants develop specific behavioral plans describing how they would act in three situations in which appearance ideals are most salient, to challenge or resist them.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention vs no intervention
| Arm | Type | Receives |
|---|---|---|
| Digital Bodies intervention | Experimental | Behavioral: Digital BodiesThe Digital Bodies intervention consists of a one-hour interactive session. The session begins with a brief self-affirmation exercise, in which participants are asked to describe something important to them and explain why. The core of the intervention involves the use of cognitive dissonance techniques and the development of critical literacy skills to encourage adolescents to critically reflect on appearance ideals, as well as to foster the skills needed to challenge such ideals. The content focuses on (i) the socially constructed nature of body ideals across time and culture, with particular attention to social media spaces, (ii) the deconstruction of myths surrounding the "perfect body" (e.g., image editing, idealization), again with a focus on social media environments, and (iii) the role of adolescents in creating, perpetuating, and reinforcing these ideals through digital technologies, including social media. |
| Waitlist control | No intervention | –No-intervention control group. To ensure that all students benefit from the intervention, the control group received the intervention after the 8 weeks. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- First or second year of upper secondary school
Key exclusion criteria (1 listed)
- They and their parents did not provide written informed consent
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 |
|---|---|---|
| Digital BodiesThe Digital Bodies intervention consists of a one-hour interactive session. The core of the intervention involves the use of cognitive dissonance techniques and the development of critical literacy skills to encourage adolescents to critically reflect on appearance ideals, as well as to foster the skills needed to challenge such ideals. | Behavioural | Digital Bodies intervention |
Primary outcome
Body Satisfaction
Time frame: Basal, post.treatment, 8-week follow-up
Body satisfaction was measured using the Body Satisfaction Scale (BSS) (Bird et al., 2013). The scale comprises five items (e.g., "Do you feel satisfied with your appearance?"), rated on a 5-point Likert scale (1 = never, 5 = very often). Total scores range from 1 to 25, with higher values indicating greater body satisfaction. The items were translated into Italian and back-translated by a professional bilingual.
Internalization of Appearance Ideals
Time frame: Basal, post-intervention, 8-week follow-up
Internalization of appearance ideals was assessed using the Sociocultural Attitudes Towards Appearance Questionnaire (SATAQ-4R). The SATAQ-4R, in both its male and female forms, consists of seven conceptually coherent subscales. Three of these capture aspects of internalization. The remaining four subscales assess perceived sociocultural pressures: from family, peers, significant others, and the media. Each item is rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores indicate higher perceived sociocultural pressures
Self-Objectification
Time frame: Basal, post-intervention, 8-week follow-up
Self-objectification was evaluated with the Likert Self-Objectification Questionnaire (LSOQ) (Wollast et al., 2021). Participants ranked 10 body attributes according to their importance for self-concept (1 = not at all important, 11 = very important). Five attributes reflect appearance (e.g., sexual appeal, physical attractiveness), while five reflect competence (e.g., health, strength). Scores are calculated by subtracting the sum of the appearance attributes from the sum of the competence attributes (range= -25 to 25). Higher scores reflect a greater emphasis on the importance of appearance-based physical attributes over competency-based attributes, that is, high levels of self-objectification.
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 2 Oct 2025.
- 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.
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 Digital Bodies in people with Wait List Control and Intervention Program, run by Villa Garda Hospital at 1 site in Italy.
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 1 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 2 Oct 2025. 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 Italy. 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?
Body Satisfaction (time frame: Basal, post.treatment, 8-week follow-up). The study lists 3 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 2 Oct 2025.