Type 2 DiabetesSALUD-MNCT07674628
SALUD-M: Acceptance Based Coping Skills for Hispanic/Latinx Military Patients With Type 2 Diabetes
A study testing Acceptance Based Coping (ABaCo) Skills Program in people with Type 2 Diabetes, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Acceptance Based Coping (ABaCo) Skills Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
Amanda Leal, 240-673-8951, amanda.leal3.ctr@health.mil
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Acceptance Based Coping (ABaCo) Skills Program
- Keywords
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance Based Coping (ABaCo) Skills ProgramBehavioural
Also called ABaCo, ABaCo+DTAU
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance Based Coping (ABaCo) Skills Program | Experimental | Participants 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 Receives: Behavioral: Acceptance Based Coping (ABaCo) Skills Program |
| Diabetes Treatment as Usual (DTAU) | No intervention | Participants randomized into the diabetes treatment as usual (DTAU) control condition will continue to receive DTAU in the military healthcare system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, 24 weeks
Secondary outcomes (3)
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.
Measured: Baseline, 6 weeks, 10 weeks, 24 weeks
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.
Measured: Baseline, 6 weeks, 10 weeks, 24 weeks
Acceptance & Action Diabetes Questionnaire
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.
Measured: Baseline, 6 weeks, 10 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start16 Jul 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association, Henry M. Jackson Foundation for the Advancement of Military Medicine, Brooke Army Medical Center, 59th Medical Wing
- Responsible party
- Principal investigator, Kathryn E. Kanzler, Baylor College of Medicine
- Investigators
- Kathryn E Kanzler, PsyD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674628
- Sponsor's protocol ID
- K08012023KH
- Other IDs
- 7-23-ICTSBMH-0
- Acronym
- SALUD-M
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07674628
- Acronym / sponsor ID
- SALUD-M / K08012023KH
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, acceptance, Latino, Hispanic, Latinx, military, health coach, paraprofessional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- American Diabetes Association, Henry M. Jackson Foundation for the Advancement of Military Medicine, Brooke Army Medical Center, 59th Medical Wing
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance Based Coping (ABaCo) Skills Program | Experimental | Behavioral: Acceptance Based Coping (ABaCo) Skills ProgramParticipants 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 intervention | –Participants randomized into the diabetes treatment as usual (DTAU) control condition will continue to receive DTAU in the military healthcare system. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance Based Coping (ABaCo) Skills ProgramAlso: ABaCo, ABaCo+DTAUThe 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. | Behavioural | Acceptance Based Coping (ABaCo) Skills Program |
Primary outcome
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).
3 secondary outcomes
Diabetes Distress Scale
Time frame: Baseline, 6 weeks, 10 weeks, 24 weeks
Summary of Diabetes Self-Care Activities
Time frame: Baseline, 6 weeks, 10 weeks, 24 weeks
Acceptance & Action Diabetes Questionnaire
Time frame: Baseline, 6 weeks, 10 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn E Kanzler, PsyD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance Based Coping (ABaCo) Skills Program in people with Type 2 Diabetes, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Leal (240-673-8951, amanda.leal3.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS Global-10) (time frame: Baseline, 6 weeks, 10 weeks, 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.