[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649874":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":65,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":98,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Pamukkale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Body-Based Regulation Group","EXPERIMENTAL","Participants assigned to this arm will receive an 8-week body-based regulation program delivered by a physiotherapist. The intervention aims to improve body awareness, autonomic regulation, and emotional regulation. Outcome assessments will be conducted at baseline and at the end of the intervention.",[13],"Behavioral: Body-Based Regulation Program",{"label":15,"type":10,"description":16,"interventionNames":17},"Mind-Based Regulation Group","Participants assigned to this arm will receive an 8-week mind-based regulation program consisting of structured psychoeducation and cognitive-emotional awareness practices. Outcome assessments will be conducted at baseline and at the end of the intervention.",[18],"Behavioral: Mind-Based Regulation Program",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Body-Based Regulation Program","Participants will receive an 8-week structured body-based regulation program administered by a physiotherapist. The program consists of 16 supervised face-to-face sessions (twice weekly, 60 minutes each) including breathing awareness exercises, body awareness-based yoga practices, non-invasive manual auricular stimulation, and restorative relaxation techniques. The intervention is designed to improve body awareness, autonomic nervous system regulation, and emotional regulation.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Mind-Based Regulation Program","Participants will receive an 8-week structured psychoeducation and cognitive-emotional awareness program developed by a clinical psychologist. The intervention aims to improve awareness of the relationships among stress, emotions, automatic thoughts, and eating behavior, recognize emotional eating triggers, develop balanced cognitive responses, and strengthen adaptive coping strategies. The program includes face-to-face sessions during weeks 1, 4, and 8, standardized digital educational materials, weekly online follow-up meetings, and self-monitoring exercises. No yoga, breathing exercises, relaxation exercises, or body-based practices are included.",[15],[31],{"name":32,"affiliation":33,"role":34},"Raziye ŞAVKIN, PhD","Pamukkale University, Faculty of Physiotherapy and Rehabilitation","STUDY_CHAIR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Raziye ŞAVKIN, Assoc. Prof.","CONTACT","+902582964253","rkirkoluk@pau.edu.tr",[42],{"facility":43,"status":25,"city":44,"state":25,"zip":25,"country":45,"countryCode":25,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Pamukkale University, Faculty of Physiotherapy and Rehabilitation, Exercise and Obesity Unit","Denizli","Turkey (Türkiye)",{"type":47,"coordinates":48},"Point",[49,50],29.0875,37.77417,{"lat":50,"lon":49},[53,55,58,61,63],{"name":54,"role":38,"phone":39,"phoneExt":25,"email":40},"Raziye Şavkın, Assoc. Prof.",{"name":56,"role":57,"phone":25,"phoneExt":25,"email":25},"Duygu Mert, PT","PRINCIPAL_INVESTIGATOR",{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Burak Bulcu, Licensed Clinical Psychologist","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":25,"phoneExt":25,"email":25},"Mehtap Mert, PT, MSc",{"name":64,"role":60,"phone":25,"phoneExt":25,"email":25},"Ummuhan Baş Aslan, Prof",{"type":57,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Raziye Şavkın","Assoc. Prof.","100649874","body-based-and-mind-based-regulation-in-overweight-and-obese-women-100649874",false,"NCT07738263","Body-Based and Mind-Based Regulation in Overweight and Obese Women","Effects of Body-Based and Mind-Based Regulation Approaches on Heart Rate Variability, Emotional Eating, and Psychological Indicators in Overweight and Obese Women: An Evaluator-Blinded Randomized Trial","Inclusion Criteria:\n\n* Female participants.\n* Age between 18 and 60 years.\n* Body mass index (BMI) between 27.0 and 39.9 kg\u002Fm².\n* No regular participation in yoga, meditation, breathing exercises, structured relaxation programs, or similar mind-body practices within the previous 3 months.\n* No initiation of a structured weight-loss program within the previous 3 months.\n* Able to attend weekly intervention sessions, modules, and study assessments.\n* Willing to refrain from starting any new exercise, yoga, meditation, diet, or weight-loss program during the study.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* BMI ≥40 kg\u002Fm².\n* Uncontrolled hypertension or severe cardiovascular disease.\n* Cardiac arrhythmia, pacemaker, or other cardiac conditions that may affect heart rate variability (HRV).\n* Regular use of beta-blockers, antiarrhythmic agents, or other medications that substantially affect HRV (including medications affecting heart rate\u002Frhythm, anticholinergic drugs, tricyclic antidepressants, and stimulant\u002Fsympathomimetic medications).\n* Neurological disease.\n* Uncontrolled thyroid disease or uncontrolled metabolic\u002Fendocrine disorders.\n* Pregnancy or breastfeeding.\n* History of bariatric surgery.\n* Initiation of weight-loss medication or GLP-1 receptor agonist therapy within the previous 6 months.\n* Current or clinically diagnosed anorexia nervosa, bulimia nervosa, binge eating disorder, or other eating disorders requiring active treatment (emotional eating alone is not an exclusion criterion).\n* Psychological or psychiatric conditions that would interfere with safe participation.\n* Diagnosed obstructive sleep apnea or untreated severe sleep disorders.\n* Regular tobacco or nicotine product use within the previous 3 months.\n* Musculoskeletal conditions preventing participation in the intervention.\n* Cardiopulmonary or orthopedic limitations that make exercise unsafe.","FEMALE","18 Years","60 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study will compare two regulation-based approaches in women with overweight or obesity. The first approach is a body-based regulation program including breathing awareness, body-awareness-based yoga practices, non-invasive manual auricular stimulation, and restorative relaxation. The second approach is a mind-based regulation program including structured psychoeducation and cognitive-emotional awareness activities focused on stress, emotions, automatic thoughts, and emotional eating.\n\nParticipants will be women aged 18 to 60 years with a body mass index between 27.0 and 39.9 kg\u002Fm². Eligible participants will be randomly assigned to one of the two intervention groups. Both programs will last 8 weeks.\n\nThe main aim of the study is to examine and compare the preliminary effects of these two approaches on heart rate variability, especially RMSSD, which is an indicator of cardiac vagal regulation. The study will also assess emotional eating, self-compassion, mindfulness, body measurements, body composition, adherence to the program, and possible adverse events. Assessments will be performed at baseline and after the 8-week intervention by an evaluator who is blinded to group allocation.",[86],"Overweight and\u002For Obesity",[88,89,90,91,92,93,94,95,96,97],"obesity","overweight","Heart Rate Variability","Emotional Eating","Body-Based Regulation","Mind-Based Regulation","Autonomic Nervous System","Psychological Well-Being","women","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-07-30",{"date":101,"type":102},"2026-07-31","ACTUAL",{"date":104,"type":80},"2026-09",{"date":106,"type":80},"2027-05",{"name":5,"class":6},1]