Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 9:50 AM
Study NCT ID:
NCT07189559
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2025-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
School-Based Body Image Concerns Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention vs no intervention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 449}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-26', 'studyFirstSubmitDate': '2025-09-16', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Satisfaction', 'timeFrame': 'Basal, post.treatment, 8-week follow-up', 'description': '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.'}, {'measure': 'Internalization of Appearance Ideals', 'timeFrame': 'Basal, post-intervention, 8-week follow-up', 'description': '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.\n\nEach item is rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores indicate higher perceived sociocultural pressures'}, {'measure': 'Self-Objectification', 'timeFrame': 'Basal, post-intervention, 8-week follow-up', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['school-based intervention', 'adolescents', 'unrealistic appearance ideals', 'social media'], 'conditions': ['Wait List Control', 'Intervention Program']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nRandomization 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).\n\nThe 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.\n\nParticipants 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.\n\nThe "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.\n\nThe 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First or second year of upper secondary school\n\nExclusion Criteria:\n\n* They and their parents did not provide written informed consent'}, 'identificationModule': {'nctId': 'NCT07189559', 'briefTitle': 'School-Based Body Image Concerns Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Villa Garda Hospital'}, 'officialTitle': 'Digital Bodies: A Brief Intervention in Secondary Schools to Reduce Negative Body Image Among Adolescents in the Digital Age', 'orgStudyIdInfo': {'id': 'D.BODY/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Bodies intervention', 'description': '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.\n\nThe 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.\n\nThe 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.', 'interventionNames': ['Behavioral: Digital Bodies']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'No-intervention control group. To ensure that all students benefit from the intervention, the control group received the intervention after the 8 weeks.'}], 'interventions': [{'name': 'Digital Bodies', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Digital Bodies intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37138', 'city': 'Garda', 'state': 'Verona', 'country': 'Italy', 'facility': 'Villa Garda Hospital', 'geoPoint': {'lat': 45.57889, 'lon': 10.71763}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Villa Garda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head nutrition and endocrinology Villa Garda Hospital', 'investigatorFullName': 'Riccardo Dalle Grave', 'investigatorAffiliation': 'Villa Garda Hospital'}}}}