Recruiting

ABaCo

Sponsor:

Baylor College of Medicine

Code:

NCT07674628

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Acceptance Based Coping (ABaCo) Skills Program

Study Details

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.

Conditions

Type 2 Diabetes

Study ID

NCT07674628

Start date

Jul 16, 2026

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Acceptance Based Coping (ABaCo) Skills Program

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

no intervention: Diabetes Treatment as Usual (DTAU)

Participants randomized into the diabetes treatment as usual (DTAU) control condition will continue to receive DTAU in the military healthcare system.

Interventions

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 measure

  • Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS Global-10) [ Time Frame: Baseline, 6 weeks, 10 weeks, 24 weeks ]
  • Hba1c (Glycated hemoglobin) [ Time Frame: Baseline, 24 weeks ]

Central Contacts and Locations

Central contacts

Amanda Leal

240-673-8951amanda.leal3.ctr@health.mil

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Amanda Leal

240-673-8951amanda.leal3.ctr@health.mil

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-07-28.