[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640987":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":44,"responsibleParty":64,"collaborators":33,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":33,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":33,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":47,"whyStopped":33,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"taVNS Plus Lifestyle Intervention","EXPERIMENTAL","Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle intervention for 12 weeks.",[13],"Device: transcutaneous auricular vagus nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Stimulation plus Lifestyle Intervention","SHAM_COMPARATOR","Participants will receive sham stimulation in addition to standardized lifestyle intervention for 12 weeks",[19],"Device: Sham",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","transcutaneous auricular vagus nerve stimulation","Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle Intervention for 12 weeks. Active stimulation will be delivered to the left cymba conchae using an intermittent waveform (15 seconds on, 5 seconds off) at 20 Hz with a pulse width of 0.2 ms. Stimulation intensity will be titrated from 0 mA to a level that produces mild tingling without obvious discomfort, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes per session, 5 days per week, for 12 weeks.",[9],[27],"Lifestyle Intervention",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham","Participants will receive sham stimulation in addition to lifestyle Intervention for 12 weeks. Sham stimulation will be applied to the left tail of the helix using the same waveform parameters, stimulation intensity titration, and treatment schedule as the active group, namely twice daily for 30 minutes per session, 5 days per week, for 12 weeks.",[15],[27],null,[35,40],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Yan Bi, MD, PhD","CONTACT","6-25-83-105302","biyan@nju.edu.cn",{"name":41,"role":37,"phone":33,"phoneExt":42,"email":43},"Tian Wei Gu, MD, PhD","(86) 25-831066","gtw0235@163.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School","RECRUITING","Nanjing","Jiangsu","210008","China","CN",{"type":54,"coordinates":55},"Point",[56,57],118.77778,32.06167,{"lat":57,"lon":56},[60,62],{"name":61,"role":37,"phone":38,"phoneExt":33,"email":39},"Yan Bi, MD,PhD",{"name":41,"role":37,"phone":63,"phoneExt":42,"email":43},"(86) 25-83106666",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Yan Bi","Chief Physician","100640987","transcutaneous-auricular-vagus-nerve-stimulation-for-poor-weight-loss-response-to-lifestyle-intervention-100640987",false,"NCT07630597","Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Lifestyle Intervention","Transcutaneous Auricular Vagus Nerve Stimulation as an Adjunctive Treatment for Overweight\u002FObese Patients With Poor Weight Loss Response to Lifestyle Intervention: A Single-Center, Randomized, Sham-Controlled Pilot Study","Inclusion Criteria:\n\n1. Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period;\n2. Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period;\n3. Current body mass index (BMI) ≥28 kg\u002Fm², or BMI ≥24 kg\u002Fm² with at least one weight-related comorbidity (e.g., hypertension or fatty liver disease);\n4. Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of diseases that may substantially affect body weight homeostasis, including Cushing's syndrome, uncontrolled thyroid disease (thyroid-stimulating hormone \\>6.0 mIU\u002FL or \\\u003C0.4 mIU\u002FL), malignancy, or similar conditions;\n2. Use within the past 3 months of medications that may significantly affect body weight, including glucocorticoids and antipsychotic agents;\n3. Skin infection or damage involving the auricular area;\n4. Women planning pregnancy in the near future;\n5. Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.","ALL","18 Years","50 Years",{"count":79,"type":80},24,"ESTIMATED","INTERVENTIONAL",[83],"NA","This single-center, randomized, single-blind, sham-controlled pilot study aims to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight\u002Fobese patients who show a poor weight loss response to lifestyle intervention. Participants who achieve no more than 5% weight loss after 12 weeks of lifestyle intervention will be randomized to receive either taVNS plus lifestyle intervention or sham stimulation plus lifestyle intervention for an additional 12 weeks. The primary objective is to compare the percent change in body weight from baseline between the two groups after 12 weeks of intervention. Secondary objectives include evaluation of changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.",[86],"Obesity & Overweight",[86,88,27,89],"Transcutaneous Auricular Vagus Nerve Stimulation","Non-responders","2026-06-01",{"date":92,"type":93},"2026-06-05","ACTUAL",{"date":95,"type":93},"2026-05-08",{"date":97,"type":80},"2027-03-31",{"name":5,"class":6},1]