[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07674628":3,"trial-entities:NCT07674628":120,"trial-summary:NCT07674628":124},{"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":40,"primary_purpose":41,"phases":42,"enrollment_info":44,"interventions":47,"primary_outcomes":56,"secondary_outcomes":65,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":15,"eligibility_criteria":78,"std_ages":93,"locations":96,"central_contacts":112,"overall_officials":114,"references":118,"see_also_links":119},"NCT07674628","K08012023KH","SALUD-M: Acceptance Based Coping Skills for Hispanic\u002FLatinx Military Patients With Type 2 Diabetes","Supporting Access for Latinx Underserved in Diabetes Management (SALUD-M): An Equity-Driven Study of Acceptance Based Coping Skills for Hispanic\u002FLatinx Military Patients With Type 2 Diabetes Mellitus","RECRUITING","2027-06-30","2026-07","2026-07-28","2026-07-16","Baylor College of Medicine","OTHER",false,"People of Hispanic or Latino\u002Fa\u002Fx (\"H\u002FL\") ethnicity, including US military servicemembers, Veterans, and their families, experience a higher prevalence of type 2 diabetes and more challenges managing diabetes than non-Hispanic White populations. Uncontrolled diabetes is linked with lower quality of life, diabetes-related emotional distress, and severe medical problems. There are many reasons for this difference, including lack of culturally appropriate and bilingual Spanish healthcare services. Additionally, military patients may have additional barrier accessing behavioral health care, which an important part of treatment for many people with diabetes, such as stigma and unique schedule challenges.\n\nTherefore, this study aims to overcome these barriers and improve healthcare and health outcomes for H\u002FL military patients. The investigators will test a values-based behavior change program, delivered using video telehealth by a bilingual English-Spanish language health coach. The 10-week Acceptance Based Coping (ABaCo) skills program includes 7 virtually-delivered lessons and was developed by the study team in partnership with civilian community health workers and patients. This study will test the helpfulness of ABaCo delivered by a health coach fluent in English and Spanish to military H\u002FL patients. This randomized controlled trial will examine changes in physical and mental health over 6 months for those who receive ABaCo, compared to those who receive usual healthcare. This project will also identify steps for implementing the ABaCo program in other military treatment facilities.\n\nThe ultimate goal of this study is to establish a helpful, easy-to-access, widely available program for H\u002FL military patients with type 2 diabetes that improves quality of life and blood sugar control, and lowers distress about diabetes. This study will also identify best approaches to providing ABaCo in military treatment facilities, providing lessons learned to other large healthcare systems.","Hispanic\u002FLatino\u002Fa\u002Fx (\"H\u002FL\") populations, including US military and Veteran patients, experience a higher prevalence of type 2 diabetes mellitus (T2DM) and more challenges with glycemic control than non-Hispanic White populations. Poor glycemic control is linked with lower quality of life, diabetes-related distress and devastating medical complications. Contributors to this health disparity are multifaceted and include a lack of culturally appropriate and language-concordant healthcare. Additionally, in military populations, significant schedule demands and stigma about behavioral health care and may preclude optimal diabetes treatment.\n\nThis study will address these barriers by testing a values-based behavior change program, delivered by a bilingual English-Spanish health coach, to enhance diabetes care for H\u002FL military patients. The 10-week Acceptance Based Coping (ABaCo) skills program includes 7 virtually-delivered lessons and was developed by the study team in partnership with civilian community health workers and patients and could improve care for H\u002FL military patients with T2DM.\n\nThe study aims are to: (1) Examine the effectiveness of ABaCo delivered by a health coach to military H\u002FL patients through a randomized controlled trial and (2) Identify barriers and facilitators to implementation at the patient and clinic levels and assess the acceptability and feasibility of implementing ABaCo in a military treatment facility.\n\nIf successful, this study will establish an accessible and effective self-management-enhancement program that improves quality of life, psychological health and glycemic control for H\u002FL military patients with T2DM; and identify implementation factors informing future scalability and sustainability of ABaCo at military treatment facilities.",[19],"Type 2 Diabetes",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"type 2 diabetes","acceptance","Latino","Hispanic","Latinx","military","health coach","paraprofessional","virtual","telehealth","acceptance and committment therapy","diabetes distress","blood glucose","HbA1c","veteran","military treatment facility","randomized controlled trial","quality of life","values","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[43],"NA",{"count":45,"type":46},100,"ESTIMATED",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"BEHAVIORAL","Acceptance Based Coping (ABaCo) Skills Program","The ABaCo program is a brief, bilingual and culturally appropriate educational program delivered virtually, based on the principles of Focused Acceptance and Commitment Therapy (ACT). ACT, a type of behavior therapy, empowers patients to engage in values-consistent activities, even in the context of great distress or adversity. ACT facilitates behavior change and good health outcomes by focusing on patient values and targeting avoidance coping (i.e., \"experiential avoidance\"). Thus, the ABaCo program was designed to help patients increase acceptance of difficult thoughts, feelings and experiences (e.g., cravings, diabetes-related distress, etc), ultimately helping them to care for their diabetes in a personally meaningful way, aligned with their valued life areas. ABaCo is delivered virtually over 6 consecutive weeks (1hr\u002Feach lesson) with a booster lesson at week 10.",[50],[54,55],"ABaCo","ABaCo+DTAU",[57,61],{"measure":58,"description":59,"timeFrame":60},"Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS Global-10)","10 Likert-scale items validated in English and Spanish assess global health-related quality of life in two areas: Physical and Global Mental Health, including functioning, emotional distress, interference, and overall quality of life, from Excellent to Poor. Scores range from 4-20 and are typically converted to T-scores; higher scores represent better health related quality of life.","Baseline, 6 weeks, 10 weeks, 24 weeks",{"measure":62,"description":63,"timeFrame":64},"Hba1c (Glycated hemoglobin)","Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control).","Baseline, 24 weeks",[66,69,72],{"measure":67,"description":68,"timeFrame":60},"Diabetes Distress Scale","17 Likert-type scale validated in English and Spanish; diabetes-related distress with subscales Emotional Burden, Physician Distress, Regimen Distress, Interpersonal Distress. The final score and subscale scores are calculated as averages (means) ranging from 1-6; higher scores indicate greater diabetes distress.",{"measure":70,"description":71,"timeFrame":60},"Summary of Diabetes Self-Care Activities","12-item Likert-type scale validated in English and Spanish, measuring engagement in recent self-care activities: medication adherence, glucose testing, diet, exercise, foot care, smoking, and general diabetes self-care. The SDSCA can be scored multiple ways; study investigators developed a composite score representing engagement in self-care activities over the past 7 days. Scores are averaged and range from 0 to 7; higher scores indicate a greater frequency of engagement in self-care activities.",{"measure":73,"description":74,"timeFrame":60},"Acceptance & Action Diabetes Questionnaire","11 Likert-type items (10 in Spanish), validated in English and Spanish, assess acceptance of distressing diabetes thoughts\u002Ffeelings and their interference. Scores range from 11 to 55, with higher scores indicating poorer diabetes acceptance\u002Fgreater experiential diabetes-related avoidance.","ALL","18 Years","70 Years",{"inclusion":79,"exclusion":86,"raw_text":92},[80,81,82,83,84,85],"Patients ages 18-70","Diagnosis of T2DM","Current HbA1c (drawn within 6 months) of 7% or greater (may be taking oral agents or injectables for diabetes control)","Evidence of avoidance coping (score \\\u003C48.4 \\[published mean\\] on the Acceptance and Action Diabetes Questionnaire) or poor self-management skills (score \\\u003C published mean on 2+ subscales of the Summary of Diabetes Self-Care, Activities)","Self-described as Hispanic\u002FLatino\u002FLatina\u002FLatinx","Preferred language of English or Spanish, (g) receiving care at the study site clinic.",[87,88,89,90,91],"End-stage renal disease (on dialysis)","A medical condition or life circumstance that would contraindicate participation","Proliferative diabetic retinopathy precluding participation","Inability to read\u002Fcomprehend the informed consent process or study instructions","Pregnant or planning to become pregnant in the next 6 months.","Inclusion Criteria:\n\n* Patients ages 18-70\n* Diagnosis of T2DM\n* Current HbA1c (drawn within 6 months) of 7% or greater (may be taking oral agents or injectables for diabetes control)\n* Evidence of avoidance coping (score \\\u003C48.4 \\[published mean\\] on the Acceptance and Action Diabetes Questionnaire) or poor self-management skills (score \\\u003C published mean on 2+ subscales of the Summary of Diabetes Self-Care, Activities)\n* Self-described as Hispanic\u002FLatino\u002FLatina\u002FLatinx\n* Preferred language of English or Spanish, (g) receiving care at the study site clinic.\n\nExclusion Criteria:\n\n* End-stage renal disease (on dialysis)\n* A medical condition or life circumstance that would contraindicate participation\n* Proliferative diabetic retinopathy precluding participation\n* Inability to read\u002Fcomprehend the informed consent process or study instructions\n* Pregnant or planning to become pregnant in the next 6 months.",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":109},"Brooke Army Medical Center","San Antonio","Texas","78234","United States",[104],{"name":105,"role":106,"phone":107,"email":108},"Amanda Leal","CONTACT","240-673-8951","amanda.leal3.ctr@health.mil",{"lat":110,"lon":111},29.42412,-98.49363,[113],{"name":105,"role":106,"phone":107,"email":108},[115],{"name":116,"affiliation":13,"role":117},"Kathryn E Kanzler, PsyD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":121,"biomarkers":123},[122],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":125,"summary":126,"prompt_version":134},true,{"design":127,"status":128,"heading":6,"summary":129,"follow_up":127,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"Not specified.","completed","{\n   \"SALUD-M: Acceptance Based Coping Skills for Hispanic\u002FLatinx Military Patients With Type 2 Diabetes\",\n   \"This study is testing a program called Acceptance Based Coping (ABaCo) Skills to help Hispanic\u002FLatinx military patients with Type 2 Diabetes manage their condition better. The ABaCo program is a short, online, and culturally appropriate educational program based on a type of therapy called Focused Acceptance and Commitment Therapy (ACT). It aims to help you engage in activities that align with your values, even when facing challenges with diabetes.\\n\\nYou may be able to join if you are 18-70 years old, have Type 2 Diabetes, and your HbA1c (a measure of blood sugar control) is 7% or higher. The study is looking to enroll about 100 participants. Researchers will measure your overall health and well-being (using PROMIS Global-10) and your HbA1c levels to see how well the program works.\",\n  \"design\": \"This is an interventional study planning to enroll 100 participants. It is testing a behavioral program called Acceptance Based Coping (ABaCo) Skills.\",\n  \"commitments\": \"You would participate in a 10-week program with 7 virtual lessons. Your health and HbA1c will be measured at the start, 6 weeks, 10 weeks, and 24 weeks.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for 24 weeks after starting the program, with measurements taken at different time points.\",\n}",221,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]