[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of the Balearic Islands\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":155},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,76,100,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100593264","implementation-of-a-diabetic-foot-prevention-strategy-in-primary-care-implanta-study-100593264",false,"NCT07004179","Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)","Implementation of a Diabetic Foot Prevention Strategy in Primary Care: Study Protocol for Two-arm Cluster Randomised Controlled Trial (iMplanta Study)","iMplanta","Inclusion Criteria:\n\n* Diagnosis of type 1 or type 2 diabetes mellitus.\n* Aged 18 years or older.\n* Attending nursing consultations at participating primary care centers during the study period.\n\nExclusion Criteria:\n\n* Patients with gestational diabetes.\n* Patients with diabetic foot ulcers prior to the start of the study.\n* Patients with lower limb amputations prior to the start of the study.","ALL","18 Years",{"count":20,"type":21},1520,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this two-arm cluster randomised controlled trial (RCT) is to evaluate the effectiveness of a new implementation strategy based on the ImM model for the Protocol of assistance to the person with diabetic foot (PAPDF) of the Balearic Islands Health Service in reducing complications of diabetic foot, compared to the current implementation strategy, in the primary care centers of Majorca. As secondary objectives we aim 1. To determine the reach of the implementation strategy in the GAPM primary care centers, 2.To compare the effectiveness of the PAPDF versus usual care in preventing diabetic foot complications, 3. To identify the number of healthcare professionals adhering to the implementation strategy and 4. To assess the sustainability of the implementation strategy over time.",[27,28],"Diabetic Foot Disease","Diabetic Foot Ulcer (DFU)",[30,31,32,33],"Diabetic foot","Implementation Sciencie","Prevention","Primary Care","NOT_YET_RECRUITING","2025-06-25",{"date":37,"type":38},"2025-06-29","ACTUAL",{"date":40,"type":21},"2025-09-01",{"date":42,"type":21},"2026-12-22",{"name":44,"class":45},"University of the Balearic Islands","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":46},"100583033","effectiveness-implementation-and-spillover-effects-of-a-culturally-adapted-dpp-in-spanish-primary-care-centers-100583033","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.",{"count":56,"type":21},139,[24],"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.",[60],"Prediabetes",[62,60,63,64,65,66,67],"Diabetes Prevention Program","Type 2 diabetes","Lifestyle","Disease prevention","Diet","Physical activity","2025-03-13",{"date":70,"type":38},"2025-03-14",{"date":72,"type":21},"2025-09",{"date":74,"type":21},"2028-03",{"name":44,"class":45},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100522085","effectiveness-of-a-guided-mobile-app-intervention-for-depression-and-anxiety-in-university-students-promes-u-study-100522085","NCT06078007","Effectiveness of a Guided Mobile App Intervention for Depression and Anxiety in University Students (PROMES-U Study)","Effectiveness of a Guided Mobile App Intervention for Depression and Anxiety in University Students: a Multicenter Randomized Controlled Trial (PROMES-U Study)","PROMES-U","Inclusion Criteria:\n\n* Eligible participants are all undergraduate students at the 6 participating universities and students followed in the PROMES-U observational study\n* Having 18 years of age or more\n* Having literacy in Spanish\n* Having access to a smartphone (Android or Apple)\n* With mild or moderate depression and\u002For anxiety symptoms screened (i.e., depression (5≤ (PHQ-9) ≤14); and\u002For anxiety (5≤ GAD-7 ≤14).\n\nExclusion Criteria:\n\n* Moderately severe or severe depression and\u002For anxiety (i.e., PHQ-9≥15 and\u002For GAD-7≥15)\n* High suicide risk\n* A history of severe psychiatric disorder (e.g., bipolar, psychosis)\n* Being on mental health treatment (i.e., medication, psychotherapy or other intervention)\n\nStudents with high suicide risk will receive a clinical alert recommending them to visit a specialist and a list of available mental health resources.",{"count":85,"type":21},600,[24],"Background: Symptoms of depression and anxiety are prevalent among Spanish university students. Minimally guided online interventions have shown promise in reducing symptomatology and preventing increased mental distress. There is a need to evaluate the effectiveness of guided preventive mental health interventions for depression and anxiety in university students.\n\nMethods: two-arm multicenter randomized controlled trial (RCT), addressed to undergraduate students from 6 public universities with symptoms of depression and\u002For anxiety. Students will be evaluated through an online survey assessing mental health problems, use of mental health services, sociodemographic variables, self-perceived health, childhood and adolescent adversities, recent stressful events, social networks, personality and university experiences. A total of 600 students will be randomly assigned to: intervention group (guided E-health prevention intervention) or control group (treatment as usual with self-monitoring). The intervention, in app format, is based on principles of cognitive behavioral therapy, includes weekly feedback based on content and participation from a psychologist and self-monitoring. Assessments will take place post-intervention (up to 6 weeks), at 6 months and 12 months after randomization. The primary outcome will be the reduction of depressive or anxiety symptoms post-intervention, assessed with the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) and the Patient Health Questionnaire-Anxiety and Depression Scale (PHQ-ADS). Secondary outcomes of the RCT will be mental wellbeing, academic stress, comorbid symptoms, and adherence. Analyses will be conducted on an intention-to-treat and per protocol basis.\n\nDiscussion: The results of the PROMES-U RCT will provide valuable information on a guided preventive online intervention that could be delivered in the campus context. In addition, results will provide information on the positive impact of the intervention on other relevant factors involved in mental health among university students.",[89,90],"Depressive Symptoms","Anxiety","RECRUITING","2024-10-29",{"date":94,"type":38},"2024-10-31",{"date":96,"type":38},"2024-10-25",{"date":98,"type":21},"2025-11",{"name":44,"class":45},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":111,"phases":4,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":46},"100553637","influence-of-social-determinants-on-lifestyle-modification-adherence-in-people-with-prediabetes-100553637","NCT06488677","Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes","Influence of Social Determinants on Lifestyle Modification Adherence in People With Prediabetes: A Sequential Explanatory Mixed-Methods Study","Inclusion Criteria:\n\n* participants of the PREDIPHONE trial assigned to the intervention group and who complete the 9-month intervention period\n\nExclusion Criteria:\n\n* Participants from the control group or those who withdrew from the trial.","20 Years","75 Years",{"count":110,"type":21},40,"OBSERVATIONAL","A sequential explanatory mixed-methods study analyzing the influence of social determinants on adherence to healthy lifestyle recommendations in individuals with prediabetes.",[114],"PreDiabetes",[116,117,60,118],"Healthy lifestyle","Social determinants of health","Therapeutic adherence and compliance","2024-07-03",{"date":121,"type":38},"2024-07-05",{"date":123,"type":21},"2024-06-30",{"date":125,"type":21},"2024-12-30",{"name":44,"class":45},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":46},"100546716","peer-led-intervention-for-individuals-with-major-depression-100546716","NCT06398561","Peer-led Intervention for Individuals With Major Depression.","SUPEERmood","Selection and withdrawal of subjects\n\nInclusion criteria:\n\n* People over 18 years of age.\n* Attending consultations with any of the professionals in the USM mental health network.\n* Having an active diagnostic label of Major Depressive Disorder, according to ICD or DSM criteria in the Primary Care e-SIAP program or meeting MINI TRAS criteria after individual interview for Major Depressive Episode.\n\nExclusion criteria\n\n* People who present mental health disorders associated with a depressive disorder and who are in the acute phase of the disease.\n* People who are not under active follow-up with any of the professionals of the USM.\n* People with mobility problems and \u002F or displacement to the health center.\n* People suffering from another disease affecting the CNS (organic brain pathology or who have suffered a severe head injury, onset dementia or any other neurodegenerative disease, etc.).\n* People with presence of uncontrolled serious medical, infectious or degenerative disease, which may interfere with affective symptomatology.\n* People with significant risk of suicide according to medical criteria, assessed through follow-up interviews conducted by mental health professionals of reference.\n* People with any medical, psychological and\u002For social problem that could seriously interfere with the patient's participation in the study.\n* People who are legally incapacitated to make health decisions.","85 Years",{"count":136,"type":21},70,[24],"Objective: To evaluate the efficacy of an adjuvant intervention based on a peer support program in the reduction of depressive symptomatology versus an online intervention in people with major depression in Primary Care Mental Health Units in Mallorca.\n\nDesign: Randomized clinical trial of two branches in a Mental Health Unit of Mallorca, where one branch will receive an adjuvant intervention based on a peer support program (Active Patient Program) and another branch (control) will receive information and exercises aimed at improving their mental health through the COGITO App, designed and validated for this purpose.\n\nScope and study subjects: The scope of the study will be the consultations of the Mental Health Unit (MHU) of Primary Care in Mallorca. The study subjects will be patients of these units who meet the criteria for Major Depression. The mental health professionals of the MHU will be in charge of recruiting participants who meet the inclusion and exclusion criteria. The required sample will be 70 subjects, 35 in each branch.\n\nVariables: The main dependent variable is depressive symptomatology, measured through the Beck Depression Inventory (BDI-II). As secondary variables, quality of life and adherence to treatment will be included.\n\nData analysis: All analyses will be carried out using the SPSS statistical program. An intention-to-treat (ITT) analysis will be performed. The efficacy of the intervention (reduction of depressive symptoms (BDI-II)) will be assessed by a general linear model (ANOVA) at 6 weeks, 6 and 12 months, adjusted for baseline values.",[140],"Depressive Disorder, Major",[142,143,144,145,146,147],"peer-leader","promotion","mental health","depression","peer to peer","health education","2024-07-02",{"date":119,"type":38},{"date":151,"type":38},"2024-05-10",{"date":153,"type":21},"2027-09-30",{"name":44,"class":45},""]