[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05502016":3,"trial-entities:NCT05502016":15,"trial-summary:NCT05502016":15},{"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":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":15,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":59,"locations":62,"central_contacts":78,"overall_officials":85,"references":89,"see_also_links":90},"NCT05502016","263202","Family Model DSME in FBOs in the RMI","Family Model Diabetes Self-Management Education in Faith-Based Organizations in the Republic of the Marshall Islands","RECRUITING","2027-01-31","2025-12","2025-12-08","2023-06-30","University of Arkansas","OTHER",null,"Health disparities in the Republic of the Marshall Islands are striking, with extremely high rates of type 2 diabetes. Documented prevalence of type 2 diabetes in the Marshall Islands ranges from 20%-50%.This is significantly higher than the global (8.5%) and United States (11%) prevalence. Diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. Diabetes self-management education and support is critical for persons with diabetes. This study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in Marshallese by trained community health workers. The study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. The primary study outcome will be glycemic control as measured by HbA1c. Secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. Survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. The control arm of the study will have two pre-intervention data collections before beginning the intervention. Data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.",[18],"Diabetes Mellitus, Type 2",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[23],"NA",{"count":25,"type":26},288,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Family Model Diabetes Self-Management Education and Support","Participants assigned to this arm receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.",[33],"Intervention",{"type":29,"name":35,"description":36,"armGroupLabels":37},"Family Model Diabetes Self-Management Education and Support (Wait-list)","Participants assigned to this arm will wait approximately 12 weeks to receive an intervention that includes a culturally adapted family model diabetes self-management education and support with at least one participating family member in a faith-based organization setting.",[38],"Wait-list Control",[40],{"measure":41,"description":42,"timeFrame":43},"Glycemic control, measured by change in mean HbA1c (%) from baseline","Point of care tests will be utilized to calculate HbA1c levels for each participant. The primary outcome measure is change in mean HbA1c (%) from baseline to immediate post-intervention, 4 months post-intervention, and 12 months post-intervention. Analyses will be adjusted for baseline HbA1c, sex, age, education, marital status, employment status, use of diabetes medications, and clustering of participants within churches.","Baseline, Immediate post-intervention, 4 months post-intervention, 12 months post-intervention",[],"ALL","18 Years",true,{"inclusion":49,"exclusion":54,"raw_text":58},[50,51,52,53],"self-reported Marshallese","18 years of age or older","have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)","have at least one family member willing to take part in the study",[55,56,57],"has received diabetes self-management education in the past five years","has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder","plans to move out of the geographic region","Inclusion Criteria:\n\n* self-reported Marshallese\n* 18 years of age or older\n* have type 2 diabetes (defined as having HbA1c equal to or greater than 6.5%)\n* have at least one family member willing to take part in the study\n\nExclusion Criteria:\n\n* has received diabetes self-management education in the past five years\n* has a condition that makes it unlikely that the participant will be able to follow the protocol, such as terminal illness, non-ambulatory, severe mental illness, severely impaired vision or hearing, eating disorder\n* plans to move out of the geographic region",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":64,"status":8,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":75},"UAMS Institute for Community Health Innovation","Springdale","Arkansas","72764","United States",[70],{"name":71,"role":72,"phone":73,"email":74},"Alix Montoya-Beltran","CONTACT","479-713-8000","amontoyabeltran@uams.edu",{"lat":76,"lon":77},36.18674,-94.12881,[79,82],{"name":80,"role":72,"phone":73,"email":81},"Betsy O'Connor, MA","geoconnor@uams.edu",{"name":83,"role":72,"phone":73,"email":84},"Brett Rowland, MA","mbrowland@uams.edu",[86],{"name":87,"affiliation":13,"role":88},"Pearl McElfish, PhD","PRINCIPAL_INVESTIGATOR",[],[]]