[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641925":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":69,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":31,"enrollmentInfo":85,"targetDuration":31,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":101,"whyStopped":31,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Twente","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","ACTIVE_COMPARATOR","Lifestyle program (control group)",[13],"Behavioral: Lifestyle program",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2","EXPERIMENTAL","Lifestyle program + coach",[19],"Device: Lifestyle program + coach",{"label":21,"type":16,"description":22,"interventionNames":23},"Arm 3","Lifestyle program + coach + CGM",[24],"Device: Lifestyle program + coach + CGM",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","Lifestyle program","Participants are asked to work on improving their lifestyle. They have access to an online community throughout the study, where they can get in touch with other participants within their research-arm. Participants are also asked to attend twelve online group sessions, during which a lifestyle coach will explain more about nutrition, physical activity, sleep, stress, social aspects, challenges and setbacks, and long-term maintenance.",[9],null,{"type":33,"name":17,"description":34,"armGroupLabels":35,"otherNames":31},"DEVICE","Idem to arm one, supplemented with a virtual AI lifestyle coach. The AI lifestyle coach can process all the information about the participant that was provided at baseline. This information is compiled into a participant profile, which the AI lifestyle coach uses to initiate personalised conversations with the participant. During these conversations, the AI lifestyle coach supports the participant through a structured coaching cycle of three phases: preparation (reflecting on what matters and co-creating a personalised plan), coaching (day-to-day support to work on the plan), and evaluation (reviewing progress and adjusting or renewing the plan). The coach draws on an evidence-based knowledge base of lifestyle interventions to recommend appropriate, evidence-informed actions. The use of the AI lifestyle coach is an additional topic to the online group sessions.",[15],{"type":33,"name":22,"description":37,"armGroupLabels":38,"otherNames":31},"Idem to arm two, but participants are also asked to wear an CGM four times for two consecutive weeks. The glucose values information collected by the CGM is used by the AI lifestyle coach to make conversations with the participant even more personalized. The use of CGMs is an additional topic to the online group sessions.",[21],[40],{"name":41,"affiliation":5,"role":42},"Goos D. Laverman, Prof. Dr.","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":31,"email":48},"Lotte G.P. Peters, MSc","CONTACT","+31534891403","lotte.peters@utwente.nl",{"name":50,"role":46,"phone":51,"phoneExt":31,"email":52},"Anouk Middelweerd, Dr","+31534897486","a.middelweerd@utwente.nl",[54],{"facility":5,"status":31,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Enschede","Overijssel","7500 AE","Netherlands","NL",{"type":61,"coordinates":62},"Point",[63,64],6.89583,52.21833,{"lat":64,"lon":63},[67,68],{"name":45,"role":46,"phone":47,"phoneExt":31,"email":48},{"name":45,"role":42,"phone":31,"phoneExt":31,"email":31},{"type":42,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Lotte Peters","MSc",[73],{"name":74,"class":6},"TNO","100641925","an-online-lifestyle-program-with-an-ai-lifestyle-coach-and-continues-glucose-monitoring-in-type-2-diabetes-100641925",false,"NCT07661381","An Online Lifestyle Program With an AI Lifestyle Coach and Continues Glucose Monitoring in Type 2 Diabetes.","\"An Online Personalised Lifestyle Program With a Virtual AI Lifestyle Coach in Combination With Continues Glucose Monitoring for People With Type 2 Diabetes.\"","PREVAIL","Inclusion Criteria:\n\n* Age: ≥18 years\n* HbA1c: ≥53 mmol\u002Fmol (7 - 12%)\n* Signed informed consent form and willing to comply with the study procedures\n* Persons who are naïve for participation in a lifestyle program for the past two years\n* Being digitally competent\n* Mastering the Dutch language\n* Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years)\n\nExclusion Criteria:\n\n* Medication use: any other glucose-lowering medication than metformin\n* Comorbidities or medical conditions requiring a special diet that conflicts with the study\n* Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight)\n* Circumstances that lead to unreliable HbA1c values, such as blood donation\n* Pregnant or lactating women","ALL","18 Years",{"count":86,"type":87},160,"ESTIMATED","INTERVENTIONAL",[90],"NA","The aim of this study is to evaluate the feasibility and effectiveness of a remote personalised lifestyle program in individuals with T2D. Outcomes will be assessed at the start and after 3, 6, and 12 months with two follow-up measurements (18 and 24 months) to determine whether participation in this re-mote lifestyle program leads to improvements in health and diabetes-related outcomes.",[93],"Diabetes Type 2",[95,96,97,98,99,100],"Lifestyle intervention","Artificial intelligence","Remote study","Dietary intake","Continuous glucose monitoring","Lifestyle coach","NOT_YET_RECRUITING","2026-06-22",{"date":104,"type":105},"2026-06-25","ACTUAL",{"date":107,"type":87},"2026-09",{"date":109,"type":87},"2028-12",{"name":5,"class":6},1]