NCT07674628 · Baylor College of Medicine
SALUD-M: Acceptance Based Coping Skills for Hispanic/Latinx Military Patients With Type 2 Diabetes
(SALUD-M)
What this study is about
People of Hispanic or Latino/a/x ("H/L") 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.
View original scientific description
People of Hispanic or Latino/a/x ("H/L") 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. Therefore, this study aims to overcome these barriers and improve healthcare and health outcomes for H/L 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/L 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. The ultimate goal of this study is to establish a helpful, easy-to-access, widely available program for H/L 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.
Interventions
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/each lesson) with a booster lesson at week 10.
Primary outcome measures
Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS Global-10)
Time frame: Baseline, 6 weeks, 10 weeks, 24 weeks
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.
Hba1c (Glycated hemoglobin)
Time frame: Baseline, 24 weeks
Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 \<48.4 \[published mean\] on the Acceptance and Action Diabetes Questionnaire) or poor self-management skills (score \< published mean on 2+ subscales of the Summary of Diabetes Self-Care, Activities)
- Self-described as Hispanic/Latino/Latina/Latinx
- Preferred language of English or Spanish, (g) receiving care at the study site clinic.
Exclusion criteria
- End-stage renal disease (on dialysis)
- A medical condition or life circumstance that would contraindicate participation
- Proliferative diabetic retinopathy precluding participation
- Inability to read/comprehend the informed consent process or study instructions
- Pregnant or planning to become pregnant in the next 6 months.
Where
- San Antonio, Texas
Collaborators
American Diabetes Association, Henry M. Jackson Foundation for the Advancement of Military Medicine, Brooke Army Medical Center, 59th Medical Wing
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations