[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548844":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":49,"locations":58,"responsibleParty":91,"collaborators":37,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":37,"enrollmentInfo":103,"targetDuration":37,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":37,"overallStatus":61,"whyStopped":37,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Beneficência Portuguesa de São Paulo","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Brazilian Diabetes Prevention Program (hybrid - a mix of in-person and remote support)","EXPERIMENTAL","The PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include healthy eating, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals.\n\nSpecifically, in this arm, PROVEN-DIA is delivered through a hybrid model combining in-person individual and group sessions with remote support contacts provided by trained Lifestyle Counselors and Lifestyle Coaches.",[13],"Behavioral: PROVEN-DIA Hybrid Lifestyle Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Brazilian Diabetes Prevention Program - TeleHealth (remote care)","The PROVEN-DIA program is a structured lifestyle change initiative organized into modules that include nutrition, physical activity, sleep, stress management, and self-care. Based on materials developed by the Brazilian Ministry of Health, including the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, the program considers participants' health status, lifestyle habits, and readiness to change in order to establish individualized lifestyle goals.\n\nSpecifically, in this arm, PROVEN-DIA is delivered exclusively through telehealth using videoconferencing and other remote communication technologies.",[18],"Behavioral: TelePROVEN-DIA Lifestyle Intervention",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Group","ACTIVE_COMPARATOR","Participants allocated to the usual care control group receive the same lifestyle guidance content as the intervention groups, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. However, this guidance is not delivered through a structured behavior change program. Individual visits are scheduled every six months according to a standardized study protocol.",[24],"Behavioral: Usual Care Lifestyle Guidance",[26,33,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","PROVEN-DIA Hybrid Lifestyle Intervention","A structured lifestyle intervention delivered through a hybrid model combining face-to-face and remote interactions over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change",[9],[32],"PROVEN-Dia",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Usual Care Lifestyle Guidance","Lifestyle guidance based on the Dietary Guidelines for the Brazilian Population and the Physical Activity Guidelines for the Brazilian Population, including recommendations regarding healthy eating, physical activity, sleep, stress management, alcohol consumption, and smoking behavior. Guidance is delivered during scheduled follow-up visits without structured behavioral counseling, goal-setting procedures, self-monitoring support, ongoing support contacts, or group education sessions.",[20],null,{"type":27,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"TelePROVEN-DIA Lifestyle Intervention","A structured lifestyle intervention delivered entirely through telehealth over 36 months. The program includes 17 individual counseling sessions, 15 structured support contacts, and 6 group education sessions designed to improve diet quality, physical activity, sleep quality, stress management, alcohol consumption, smoking behavior, and self-care practices through behavior change strategies tailored to participants' readiness to change.",[15],[43],"TelePROVEN-Dia",[45],{"name":46,"affiliation":47,"role":48},"Angela C Bersch-Ferreira, PhD","Hospital Beneficência Portuguesa de São Paulo","PRINCIPAL_INVESTIGATOR",[50,54],{"name":46,"role":51,"phone":52,"phoneExt":37,"email":53},"CONTACT","(55 11) 988295600","angelacbferreira@gmail.com",{"name":55,"role":51,"phone":56,"phoneExt":37,"email":57},"Raira Pagano","5511954729698","raira.pagano@bp.org.br",[59,77],{"facility":60,"status":61,"city":62,"state":63,"zip":37,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Hospital de Clínicas de Goiás - UFG","RECRUITING","Goiânia","Goiás","Brazil","BR",{"type":67,"coordinates":68},"Point",[69,70],-49.25389,-16.67861,{"lat":70,"lon":69},[73],{"name":74,"role":51,"phone":75,"phoneExt":37,"email":76},"Ana Paula Perillo, PhD","55 (62) 98414-6969","anapaulaperillo@ufg.br",{"facility":78,"status":61,"city":79,"state":80,"zip":37,"country":64,"countryCode":65,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Universidade Federal de Viçosa","Viçosa","Minas Gerais",{"type":67,"coordinates":82},[83,84],-42.88194,-20.75389,{"lat":84,"lon":83},[87],{"name":88,"role":51,"phone":89,"phoneExt":37,"email":90},"Josefina Bressan, PhD","55 31 98606-3903","jbrm@ufv.br",{"type":92,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100548844","effectiveness-of-the-brazilian-diabetes-prevention-program-100548844",false,"NCT06426277","Effectiveness of the Brazilian Diabetes Prevention Program","Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)","PROVEN-DIA","Inclusion Criteria\n\n* Be 18 years or older (no maximum age for being eligible)\n* Have a body mass index (BMI) between 18,5 and 34,9kg\u002Fm²\n* Have, at least, one electronic device (includes any of the following devices):\n\n  * Computer\n  * Laptop\u002Fnotebook\n  * Tablet\n  * Smartphone\n* Have access to internet (broadband, 3G, 4G, 5G, among others) Without previous nutritional counseling (within the 6 months prior to recruitment\u002Frandomization\u002Fintervention) Without supervision by a Physical Education Professional (Personal Trainer) in the past 6 months\n* Living near the research center (at maximum 60 minutes)\n* Diagnosis of prediabetes defined as two HbA1c measurements between 5.7% and 6.4% collected 7 to 90 days apart.\n\nExclusion Criteria:\n\n* Diagnosis of Diabetes Mellitus (including current or recent use, within three months, of glucose-lowering medication)\n* Underlying disease likely to limit life expectancy and\u002For increase the risk of interventions influencing the risk of developing T2D\n* Diagnosis of Renal Disease\n* Diagnosis of Pulmonary Disease\n* Gastrointestinal Disease\n* Secondary prevention for Cardiovascular Disease\n* Endocrine Diseases\n* Weight loss exceeding 10% in the last 6 months (except postpartum-related)\n* Uncontrolled Hypertension\n* Diagnosis of Polycystic Ovary Syndrome (self-reported)\n* Patients undergoing treatment for Tuberculosis (except those using isoniazid \\[INH\\] as prophylaxis)\n* Presence of diseases that may severely reduce life expectancy or the ability to participate in the study\n* Pregnant or breastfeeding women\n* Severe psychiatric disorders that, in the opinion of the clinical team, hinder participation in the program\n* Acute or chronic excessive alcohol consumption\n* Congestive Heart Failure (CHF) with a New York Heart Association Functional Class (NYHA) \\> 2\n* Need for referral to a cardiologist according to the Physical Activity Readiness Questionnaire (PAR-Q)\n* Current or recent participation (within the last six months) in another clinical trial that impacts the interventions and\u002For is associated with the study outcomes (in case of doubt, contact the coordinating center)\n* Likely relocation away from the research collaborating center within the next 3 years\n* Another household member is a participant or a team member of the PROVEN-DIA study\n* Unwillingness to accept treatment assignment by randomization and\u002For refusal to participate in the study (signing the Informed Consent Form)\n* Continuous use of the following medications:\n\nCorticosteroids other than topical, ophthalmic, or inhaled preparations Antineoplastic agents Psychoactive agents Other medications.\n\n• Participant from the pilot Randomized Clinical Trial (Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia), NCT05689658)","ALL","18 Years",{"count":104,"type":105},1305,"ESTIMATED","INTERVENTIONAL",[108],"NA","The aim of this multicenter, randomized controlled trial is to assess the effectiveness of the Brazilian Diabetes Prevention Program (delivered face-to-face or via e-health) in preventing type 2 diabetes (T2D) in at least 1,305 adults at high risk of T2D over a 3-year follow-up period. Our outcomes include the incidence of T2D, body weight (kg), BMI, glycemic biomarkers, use of antidiabetic drugs, the proportion of individuals achieving controlled glycemia or HbA1c levels without medication, diet quality, moderate-to-vigorous physical activity (min\u002Fweek), prevalence of physical inactivity, sleep quality, perceived stress, alcohol consumption, smoking, and quality of life. In addition, social, cultural, educational, and geographical factors at the community level will be analyzed throughout the follow-up to determine their association with the incidence of T2D.",[111,112],"Prediabetic State","Pre Diabetes","2026-06-22",{"date":115,"type":116},"2026-06-25","ACTUAL",{"date":118,"type":116},"2024-12-01",{"date":120,"type":105},"2029-12-31",{"name":5,"class":6},2]