nctId: NCT06387719 id: PREC-BED Study briefTitle: Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity acronym: PREC-BED overallStatus: RECRUITING date: 2023-07-21 date: 2025-03 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: Fundació Sant Joan de Déu class: OTHER name: Instituto de Salud Carlos III 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. 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 studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 102 type: ESTIMATED name: Magnetic resonance imaging measure: Neuroimaging assessment measure: Neuroimaging assessment measure: Height measure: Weight measure: Waist perimeter measure: BMI measure: Blood pressure measure: Fasting glucose measure: Triglycerides measure: HDL cholesterol measure: Developmental Tanner stage measure: Adherence to Mediterranean diet measure: Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis. measure: Functioning measure: Depression measure: Anxiety measure: Emotion Regulation measure: Eating symptomatology measure: Eating symptomatology measure: Temperamental tendencies for sensitivity to punishment and sensitivity to reward. measure: Food Addiction measure: Food intake measure: General Intelligence measure: Attention ability measure: Visuo-constructional ability and visual memory measure: Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed. measure: Executive function: working memory ability measure: Executive function: decision-making abilities reward based measure: Executive function: ability to inhibit cognitive interference measure: Executive function: planning and strategic organisation sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: Hospital Sant Joan de Déu status: RECRUITING city: Esplugues De Llobregat state: Barcelona zip: 08950 country: Spain name: ESTHER VIA VIRGILI role: CONTACT phone: 34 + 673342094 email: esther.via@sjd.es name: ESTHER VIA VIRGILI role: PRINCIPAL_INVESTIGATOR name: EDUARDO SERRANO role: SUB_INVESTIGATOR name: RAQUEL CECILIA role: SUB_INVESTIGATOR name: SILVIA MARÍN role: SUB_INVESTIGATOR name: MARINA LLOBET role: SUB_INVESTIGATOR name: LAURA MARITZA ASTIASUAINZARRA VILLA role: SUB_INVESTIGATOR name: LILIANA SZEGHALMI role: SUB_INVESTIGATOR name: ANTONIO PÉREZ role: SUB_INVESTIGATOR name: MATTHIEU GILSON role: SUB_INVESTIGATOR name: MANEL VILA-VIDAL role: SUB_INVESTIGATOR name: GUIDO FRANK role: SUB_INVESTIGATOR name: CHRISTIAN STEPHAN OTTO role: SUB_INVESTIGATOR lat: 41.37732 lon: 2.08809 hasResults: False