SALUD-M: Acceptance Based Coping Skills for Hispanic/Latinx Military Patients With Type 2 Diabetes
SALUD-M
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
2 other identifiers
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jul 2026
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
June 29, 2026
CompletedStudy Start
First participant enrolled
July 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
July 28, 2026
July 1, 2026
8 months
June 23, 2026
July 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Hba1c (Glycated hemoglobin)
Average blood glucose levels in past 3 months; higher percentages reflect higher levels (worse glycemic control).
Baseline, 24 weeks
Secondary Outcomes (3)
Diabetes Distress Scale
Baseline, 6 weeks, 10 weeks, 24 weeks
Summary of Diabetes Self-Care Activities
Baseline, 6 weeks, 10 weeks, 24 weeks
Acceptance & Action Diabetes Questionnaire
Baseline, 6 weeks, 10 weeks, 24 weeks
Other Outcomes (3)
Acceptability of the intervention: participant interviews & satisfaction ratings
10 weeks (post-intervention)
Self-Compassion Scale - Short Form
Baseline, 6 weeks, 10 weeks, 6 months
Three-Item Loneliness Scale (UCLA-3)
Baseline, 6 weeks, 10 weeks, 6 months
Study Arms (2)
Acceptance Based Coping (ABaCo) Skills Program
EXPERIMENTALParticipants randomized to the active intervention will undergo individual virtual classes once a week for 6 weeks (\~30mins), a booster (review) class at week 10, and one follow-up class at 6 months post enrollment, for a total of 7 virtual calls. These virtual visits will be with a health coach trained and supervised in providing the ABaCo skills training program. All participants will continue to receive DTAU through the military healthcare system. ABaCo Weekly Topic Overview: Week 1:Understanding avoidance coping; identifying valued life areas Week 2: Building social support; using assertive communication Week 3: Accepting difficult thoughts \& feelings; making meaningful choices Week 4: Noticing \& letting go of unhealthy patterns; developing new life stories Week 5: Connecting to what matters in the present; committing to values Week 6: Reinforcing changes
Diabetes Treatment as Usual (DTAU)
NO INTERVENTIONParticipants randomized into the diabetes treatment as usual (DTAU) control condition will continue to receive DTAU in the military healthcare system.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- American Diabetes Associationcollaborator
- Henry M. Jackson Foundation for the Advancement of Military Medicinecollaborator
- Brooke Army Medical Centercollaborator
- 59th Medical Wingcollaborator
Study Sites (1)
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn E Kanzler, PsyD
Baylor College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 23, 2026
First Posted
June 29, 2026
Study Start
July 16, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
July 28, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available beginning 3 months and ending 5 years after publication of the primary outcomes.
- Access Criteria
- Study sponsors, study personnel and collaborators, as well as external researchers who provide a methodologically sound proposal with analyses that achieve the aims in the approved proposal.
Based on ethical considerations, the de-identified data produced during the project will be preserved with the intention of sharing with appropriate requestors: standardized survey data; clinical data (i.e., demographics, lab values); quantitative implementation data (e.g., counts for recruitment, retention, referrals); qualitative data (aggregated matrix of interview responses by participants and clinicians/ administrators). Any information that is published, reported, or otherwise released will be in aggregate/summary form and will not contain any personal identifiers. None of the 18 HIPAA identifiers will be released. To facilitate the interpretation of the data, metadata, including protocols and public data collection instruments, will be shared and associated with the relevant datasets.