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NCT Number: NCT07674628

SALUD-M: Acceptance Based Coping Skills for Hispanic/Latinx Military Patients With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location status: Recruiting

Location contact

Amanda Leal

CONTACT

[email protected]

240-673-8951

About this study

Hispanic/Latino/a/x ("H/L") 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.

This 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/L 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/L military patients with T2DM.

The study aims are to: (1) Examine the effectiveness of ABaCo delivered by a health coach to military H/L 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.

If 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/L military patients with T2DM; and identify implementation factors informing future scalability and sustainability of ABaCo at military treatment facilities.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acceptance Based Coping (ABaCo) Skills Program

Behavioral

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.

Other names: ABaCo, ABaCo+DTAU

Primary outcomes

  1. 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.

  2. Hba1c (Glycated hemoglobin)

    Time frame: Baseline, 24 weeks

    Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control).

Secondary outcomes

  1. Diabetes Distress Scale

    Time frame: Baseline, 6 weeks, 10 weeks, 24 weeks

    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.

  2. Summary of Diabetes Self-Care Activities

    Time frame: Baseline, 6 weeks, 10 weeks, 24 weeks

    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.

  3. Acceptance & Action Diabetes Questionnaire

    Time frame: Baseline, 6 weeks, 10 weeks, 24 weeks

    11 Likert-type items (10 in Spanish), validated in English and Spanish, assess acceptance of distressing diabetes thoughts/feelings and their interference. Scores range from 11 to 55, with higher scores indicating poorer diabetes acceptance/greater experiential diabetes-related avoidance.

Other outcomes

  1. Acceptability of the intervention: participant interviews & satisfaction ratings

    Time frame: 10 weeks (post-intervention)

    Semistructured interviews include 3 Likert-type scale items previously used by the research team to assess participant satisfaction: ease of learning, overall satisfaction, and likelihood of recommending. Scores range from 0-10 with higher scores indicating greater acceptability.

  2. Self-Compassion Scale - Short Form

    Time frame: Baseline, 6 weeks, 10 weeks, 6 months

    12 Likert scale items assess self-compassion with scores ranging from 12-60; higher scores represent greater self-compassion.

  3. Three-Item Loneliness Scale (UCLA-3)

    Time frame: Baseline, 6 weeks, 10 weeks, 6 months

    3-item Likert scale measuring loneliness; scores range from 3-9, with higher scores indicating greater loneliness.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Leal

CONTACT

[email protected]

240-673-8951

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • 59th Medical Wing
  • American Diabetes Association
  • Brooke Army Medical Center
  • Henry M. Jackson Foundation for the Advancement of Military Medicine

Registry information

Official study title

Supporting Access for Latinx Underserved in Diabetes Management (SALUD-M): An Equity-Driven Study of Acceptance Based Coping Skills for Hispanic/Latinx Military Patients With Type 2 Diabetes Mellitus

Acronym: SALUD-M

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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