[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554171":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":44,"centralContacts":45,"locations":44,"responsibleParty":51,"collaborators":44,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":44,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":81,"whyStopped":44,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":44},{"fullName":5,"class":6},"G. d'Annunzio University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"(1)TAU","ACTIVE_COMPARATOR","treatment-as-usual for weight loss (TAU)",[13],"Behavioral: treatment-as-usual",{"label":15,"type":10,"description":16,"interventionNames":17},"(2)TAU+GSH","combined TAU and guided self-help for improving eating behaviors (TAU+GSH)",[18],"Behavioral: combined TAU and guided self-help",{"label":20,"type":10,"description":21,"interventionNames":22},"(3)TAU+GSH+BF","combined TAU, GSH, and biofeedback (TAU+GSH+BF)",[23],"Behavioral: combined TAU, GSH, and biofeedback",[25,32,38],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","treatment-as-usual","life style modification intervention for weight loss",[9],[31],"TAU",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"combined TAU and guided self-help","combined TAU and guided self-help for improving eating behaviors",[15],[37],"TAU+GSH",{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"combined TAU, GSH, and biofeedback","combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation",[20],[43],"TAU+GSH+BF",null,[46],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},"CHIARA CONTI, PhD","CONTACT","+3908713555338","cconti@unich.it",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","CHIARA CONTI","Associate professor","100554171","integrative-intervention-strategies-for-binge-eating-in-patients-with-overweight-or-obesity-100554171",false,"NCT06495619","Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity","Effectiveness of Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity: A Multidisciplinary Approach","BE-side","Inclusion Criteria:(1) age 18-65 years; (2) BMI≥25 kg\u002Fm2; (3) ability to read and write in Italian; (4) Binge Eating Disorder (BED) or subthreshold BED status.\n\n\\-\n\nExclusion Criteria: (1) current treatment for BE with a registered psychologist; (2) severe psychiatric disorders; (4) cognitive impairment; (5) pregnancy; (6) severe medical comorbidity.\n\n\\-","ALL","18 Years","65 Years",{"count":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71],"NA","The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight\u002Fobesity and binge eating (BE):\n\n1. treatment-as-usual for weight loss (TAU);\n2. combined TAU and guided self-help for improving eating behaviors (TAU+GSH);\n3. combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs).\n\nThe secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers.\n\nThe TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.",[74,75],"Binge Eating","Overweight and Obesity",[74,77,78,79,80],"Overweight","Obesity","Guided Self-Help","Biofeedback","NOT_YET_RECRUITING","2024-07-03",{"date":84,"type":85},"2024-07-11","ACTUAL",{"date":87,"type":68},"2024-08-01",{"date":89,"type":68},"2025-06-30",{"name":5,"class":6}]