protocolSection identificationModule nctId: NCT06387719, orgStudyIdInfo id: PREC-BED Study, briefTitle: Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity, acronym: PREC-BED, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-21, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Fundació Sant Joan de Déu, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule briefSummary: BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED., conditionsModule conditions: Binge-Eating Disorder, conditions: Obesity, conditions: Eating Disorders, conditions: BED, conditions: Other Specified Feeding or Eating Disorder, conditions: Eating Disorder Nos, conditions: Emotion Regulation, conditions: Food Addiction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic resonance imaging, outcomesModule primaryOutcomes measure: Neuroimaging assessment, primaryOutcomes measure: Neuroimaging assessment, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Waist perimeter, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: HDL cholesterol, secondaryOutcomes measure: Developmental Tanner stage, secondaryOutcomes measure: Adherence to Mediterranean diet, secondaryOutcomes measure: Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis., secondaryOutcomes measure: Functioning, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Emotion Regulation, secondaryOutcomes measure: Eating symptomatology, secondaryOutcomes measure: Eating symptomatology, secondaryOutcomes measure: Temperamental tendencies for sensitivity to punishment and sensitivity to reward., secondaryOutcomes measure: Food Addiction, secondaryOutcomes measure: Food intake, secondaryOutcomes measure: General Intelligence, secondaryOutcomes measure: Attention ability, secondaryOutcomes measure: Visuo-constructional ability and visual memory, secondaryOutcomes measure: Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed., secondaryOutcomes measure: Executive function: working memory ability, secondaryOutcomes measure: Executive function: decision-making abilities reward based, secondaryOutcomes measure: Executive function: ability to inhibit cognitive interference, secondaryOutcomes measure: Executive function: planning and strategic organisation, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Sant Joan de Déu, status: RECRUITING, city: Esplugues De Llobregat, state: Barcelona, zip: 08950, country: Spain, contacts name: ESTHER VIA VIRGILI, role: CONTACT, phone: 34 + 673342094, email: esther.via@sjd.es, contacts name: ESTHER VIA VIRGILI, role: PRINCIPAL_INVESTIGATOR, contacts name: EDUARDO SERRANO, role: SUB_INVESTIGATOR, contacts name: RAQUEL CECILIA, role: SUB_INVESTIGATOR, contacts name: SILVIA MARÍN, role: SUB_INVESTIGATOR, contacts name: MARINA LLOBET, role: SUB_INVESTIGATOR, contacts name: LAURA MARITZA ASTIASUAINZARRA VILLA, role: SUB_INVESTIGATOR, contacts name: LILIANA SZEGHALMI, role: SUB_INVESTIGATOR, contacts name: ANTONIO PÉREZ, role: SUB_INVESTIGATOR, contacts name: MATTHIEU GILSON, role: SUB_INVESTIGATOR, contacts name: MANEL VILA-VIDAL, role: SUB_INVESTIGATOR, contacts name: GUIDO FRANK, role: SUB_INVESTIGATOR, contacts name: CHRISTIAN STEPHAN OTTO, role: SUB_INVESTIGATOR, geoPoint lat: 41.37732, lon: 2.08809, hasResults: False