[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07019649":3,"trial-entities:NCT07019649":97,"trial-summary:NCT07019649":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":81,"locations":83,"central_contacts":93,"overall_officials":94,"references":95,"see_also_links":96},"NCT07019649","2225114-1","Randomized Pilot Trial of AYUDA Program for Younger Latinx Adults With Type 2 Diabetes","Tailoring Initial Type 2 Diabetes Care to Meet the Needs of Younger Latinx Adults: A Randomized Pilot Study","ENROLLING_BY_INVITATION","2026-12","2025-05","2025-06-13","2025-06-18","Kaiser Permanente","OTHER",false,"The study will evaluate the feasibility, acceptability, and effectiveness of AYUDA (Assisting Younger Adults with Diabetes), a 12-week culturally text message program for Latinx adults newly diagnosed with type 2 diabetes who are caregivers to a child under 18 years old within Kaiser Permanente Northern California.","After designing the AYUDA program with input from the people it is meant to help, we are conducting a randomized pilot study. This study will test the program with younger Latinx adults who have recently been diagnosed with type 2 diabetes and who are also caregivers for dependent children.\n\nAYUDA is a health system specifically designed for this group, focusing on their life stage as young adults and their cultural background. The study will evaluate how well AYUDA helps participants reach important early blood sugar control goals, which can lead to better health over time and reduce complications.",[19],"Diabetes Mellitus, Type 2",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},204,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","AYUDA Program","Participants randomized to the intervention arm will be enrolled in the AYUDA program, where they will receive text messages twice a week over 12 weeks containing diabetes education and self-management resources, including links to resources available to all KPNC members.",[31],[35],{"measure":36,"description":37,"timeFrame":38},"Differences between study arms in HbA1c change 6-months following enrollment","Change in HbA1c will be assessed using HbA1c values obtained through routine care, with the most recent HbA1c preceding study enrollment and the HbA1c value closest to 6-months following enrollment used to assess HbA1c change.","6-months following enrollment",[40,43,46,49,52,55,59,61,63],{"measure":41,"description":42,"timeFrame":38},"Healthcare contact","Differences in healthcare contact with members of the T2D diabetes care team, including care manager, PCPs, educators.",{"measure":44,"description":45,"timeFrame":38},"Completion of recommended HbA1c monitoring","Completing HbA1c labs",{"measure":47,"description":48,"timeFrame":38},"T2D-related medication initiation","Initiation of T2D-related medication",{"measure":50,"description":51,"timeFrame":38},"T2D-related medication adherence","Adherence to T2D-related medication",{"measure":53,"description":54,"timeFrame":38},"Use of remote glucose monitoring to measure glucose levels","Use of a remote glucose monitoring to measure glucose levels",{"measure":56,"description":57,"timeFrame":58},"Participant-reported measures: Diabetes distress","Assessed at study enrollment and 6-months following enrollment","Study enrollment and 6-months following enrollment",{"measure":60,"description":57,"timeFrame":58},"Participant-reported measures: Motivation and locus of control",{"measure":62,"description":57,"timeFrame":58},"Participant-reported measures: Care Experience",{"measure":64,"description":57,"timeFrame":58},"Participant-reported measures: Children's Behaviors","ALL","18 Years","44 Years",true,{"inclusion":70,"exclusion":77,"raw_text":80},[71,72,73,74,75,76],"KPNC member, age \\>18 and age \\\u003C45 with","New clinical diagnosis of T2D within the prior 6 months","Caregiver to at least one child \\\u003C18 years of age at time of diabetes diagnosis","Identifies at Latino\u002Fa\u002Fx","Can receive text messages","Proficient (written and spoken) in English or Spanish",[78,79],"Pregnant women","Type 1 Diabetes","Inclusion Criteria:\n\n* KPNC member, age \\>18 and age \\\u003C45 with\n* New clinical diagnosis of T2D within the prior 6 months\n* Caregiver to at least one child \\\u003C18 years of age at time of diabetes diagnosis\n* Identifies at Latino\u002Fa\u002Fx\n* Can receive text messages\n* Proficient (written and spoken) in English or Spanish\n\nExclusion Criteria:\n\n* Pregnant women\n* Type 1 Diabetes",[82],"ADULT",[84],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Kaiser Permanente Northern California","Pleasanton","California","94588","United States",{"lat":91,"lon":92},37.66243,-121.87468,[],[],[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":102,"prompt_version":102},null]