[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573367":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":27,"studyPopulation":16,"armGroups":28,"interventions":41,"overallOfficials":16,"centralContacts":50,"locations":57,"responsibleParty":71,"collaborators":16,"id":73,"slug":16,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":16,"enrollmentInfo":81,"targetDuration":16,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":16,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"West German Center of Diabetes and Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"body weight","body weight in kg","3 months",[14],{"measure":10,"description":11,"timeFrame":15},"12 months",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":22,"maskingDescription":16,"whoMasked":23},"TRIPLE",[24,25,26],"CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Background: Overweight and obesity are an increasing problem. Therefore, the Low-Insulin-Method was developed to support overweight and obese people in weight loss.\n\nMethod: In a randomized controlled clinical trial, the effect of the lifestyle intervention program 'Low-Insulin-Method', delivered by the Low-Insulin-App including low-carb diet, physical activity, self monitoring of weight, and self-monitoring of breath acetone (SMBA) is examined compared to a control group without information about ketosis level. Weight change will be compared after 3 and 12 months.\n\nObjective: The aim is to develop a training and counseling program for overweight or obese individuals with diabetes risk or type 2 diabetes, which can be used both for primary and for tertiary prevention of overweight-related diseases.",[29,36],{"label":30,"type":31,"description":32,"interventionNames":33},"Intervention group","EXPERIMENTAL","lifestyle intervention including information about ketosis level",[34,35],"Other: self-monitoring of breath acetone","Other: lifestyle-intervention via LIM-App",{"label":37,"type":38,"description":39,"interventionNames":40},"control group","ACTIVE_COMPARATOR","lifestyle intervention without information about ketosis level",[35],[42,46],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":16},"self-monitoring of breath acetone","Participants perform self-monitoring of braeth acetone in order to get information about their ketosis state.",[30],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":16},"lifestyle-intervention via LIM-App","Participants are offered a lifestyle intervention via LIM-App.",[30,37],[51],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Stephan Martin","CONTACT","049-2115660360","70","stephan.martin@uni-duesseldorf.de",[58],{"facility":5,"status":16,"city":59,"state":16,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Düsseldorf","40591","Germany","DE",{"type":64,"coordinates":65},"Point",[66,67],6.77927,51.22319,{"lat":67,"lon":66},[70],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},{"type":72,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100573367",false,"NCT06745362","Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone","WeR-LIM-SMBA","Inclusion Criteria:\n\n* Body Mass Index \\> 25kg\u002Fm2\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":82,"type":83},42,"ESTIMATED","INTERVENTIONAL",[86],"NA","The goal of this clinical trial is to learn if lifestyle intervention with information about ketosis state supports weight reduction in overweight adults.\n\nResearchers will compare an App-based lifestyle intervention with self-monitoring of breath acetone vs. lifestyle intervention alone.\n\nParticipants will:\n\nGet a lifestyle intervention via the LIM-App for 12 months. Report body weight.",[89],"Overweight and Obese Volunteers",[91,92,93],"lifestyle intervention","weight reduction","ketosis","NOT_YET_RECRUITING","2025-06-25",{"date":97,"type":98},"2025-06-29","ACTUAL",{"date":100,"type":83},"2026-01-01",{"date":102,"type":83},"2027-12-31",{"name":5,"class":6},1]