[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583033":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":56,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of the Balearic Islands","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Adapted Diabetes Prevention Program","EXPERIMENTAL","12-month group-based behavioural program on lifestyle changes",[13],"Behavioral: Adapted Diabetes Prevention Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","ACTIVE_COMPARATOR","Usual care according to national guidelines",[19],"Behavioral: Usual Care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Participants assigned to this group will participate in a group-based behavioural change program to improve diet and increase physical activity levels during 12 months.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care","Participants assigned to this groups will receive usual care according to national guidelines",[15],[31],{"name":32,"affiliation":33,"role":34},"Miquel Bennasar-Veny, PhD","University of the Baleric Islands","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+34 971172367","miquel.bennasar@uib.es",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Gerència d'Atenció Primària de Mallorca","Palma de Mallorca","Balearic Islands","07002","Spain","ES",{"type":49,"coordinates":50},"Point",[51,52],2.65024,39.56939,{"lat":52,"lon":51},[55],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[59],{"name":60,"class":61},"Instituto de Salud Carlos III","OTHER_GOV","100583033","effectiveness-implementation-and-spillover-effects-of-a-culturally-adapted-dpp-in-spanish-primary-care-centers-100583033",false,"NCT06871059","Effectiveness, Implementation and Spillover Effects of a Culturally Adapted DPP in Spanish Primary Care Centers","Effectiveness, Implementation and Spillover Effects of a Culturally Adapted Diabetes Prevention Program in Spanish Primary Care Centers: a Cluster Randomized Hybrid Type II Trial","ALADIM","Inclusion Criteria:\n\nAge ≥18 years; body mass index (BMI) of ≥25 kg\u002Fm2 (≥23 kg\u002Fm2, if Asian); fasting plasma glucose (FPG) between 1010 and 125 mg\u002FdL, or plasma glucose of 140 to 199 mg\u002Fdl measured 2 hours after a 75 g glucose load, or HbA1c between 5.7% and 6.4%, or with a documented history of gestational diabetes mellitus during a previous pregnancy.\n\nExclusion Criteria:\n\nPrevious diagnosis of type 1 or type 2 diabetes; current use of antidiabetic medications; pregnancy at time of enrollment; terminal illness; institutionalization; dementia or significant cognitive impairment; major surgery or hospitalization in the previous 3 months; presence of any medical or psychological condition limiting participation; and concomitant active participation in another clinical trial.","ALL","18 Years",{"count":73,"type":74},139,"ESTIMATED","INTERVENTIONAL",[77],"NA","The ALADIM trial is a hybrid type II effectiveness-implementation cluster-randomized controlled, parallel, two arm, superiority trial. The clusters consist of 10 Primary Care Centers (PCCs) of Mallorca (Balearic Islands, Spain), which are randomly assigned to either the intervention or the control group in a 1:1 ratio. The intervention group (5 PCCs) receives training and supporting material to facilitate the implementation of the adapted DPP and effectively deliver the program over a 12-month period. The control group (5 PCCs) continues providing usual care, in line with standard healthcare practices. Effectiveness outcomes are assessed at participant level according to a cluster-randomized controlled design with data collection at baseline, 6-month and 12-month during the intervention period, and at 18-month follow-up to evaluate mid-term effects post-intervention. Implementation outcomes are assessed at PCC level throughout the study period. Prior to the hybrid trial, the DPP will be culturally and contextually adapted to the Spanish Primary Care setting.\n\nThe DPP will be culturally adapted using the Intervention Mapping ADAPT (IM-ADAPT) approach. Simultaneously, the implementation strategy will be designed using the Implementation Mapping approach.",[80],"Prediabetes",[82,80,83,84,85,86,87],"Diabetes Prevention Program","Type 2 diabetes","Lifestyle","Disease prevention","Diet","Physical activity","NOT_YET_RECRUITING","2025-03-13",{"date":91,"type":92},"2025-03-14","ACTUAL",{"date":94,"type":74},"2025-09",{"date":96,"type":74},"2028-03",{"name":5,"class":6},1]