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Type 2 DiabetesABaCoNCT06445725

Acceptance Based Coping Skills for Diabetes Delivered By Promotores

A study testing Acceptance Based Coping (ABaCo) in people with Type 2 Diabetes, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this pilot clinical trial is to learn about the feasibility and acceptability of promotores (community health workers) delivering an educational intervention for Hispanic/Latino patients with type 2 diabetes. The main questions it aims to answer are: 1. 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)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
4 Mar 2024to 24 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Age 18-70
  • Diagnosis of Type 2 Diabetes (T2DM)
  • HbA1c of 7.5% or greater (may be taking oral agents or injectables for T2DM management)
  • Evidence of avoidance coping (prescreen of <48.4 on English or a <52 on the Spanish Acceptance and Action Diabetes Questionnaire) and/or poor self-management skills (prescreen below recommended frequencies in 2 or more sub-scales of the Summary of Diabetes Self-Care Activities)
  • Self-identifies as Hispanic/Latino
  • Receiving ongoing care at study site clinic
  • Preferred language is English or Spanish

Who cannot join

  • A medical condition or life circumstance that would contraindicate participation
  • Inability to read/comprehend the informed consent process or study instructions

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: Acceptance Based Coping (ABaCo) Skills Delivered By Promotores for Hispanic/Latino Patients With Type 2 Diabetes

The goal of this pilot clinical trial is to learn about the feasibility and acceptability of promotores (community health workers) delivering an educational intervention for Hispanic/Latino patients with type 2 diabetes.

The main questions it aims to answer are:

Read more
  1. What is the impact of the ABaCo program on participants' blood sugar management and quality of life?
  2. How well are we able to enroll participants and keep them in the ABaCo program?
  3. Is this telephone-based, educational ABaCo program acceptable?

Participants will be asked to:

  • Participate in four research visits: provide fingerstick blood samples before and after the program (at 6 months), and complete questionnaires at four times times during the program (before, twice during, and at 6 months).
  • Participate in the ABaCo program: join seven (7) individual phone call visits with promotores to review educational information about caring for diabetes while keeping connected to life values. Each phone call lasts approximately 45 minutes once per week for six (6) weeks, then a refresher visit is a month later.
Read the detailed description

This overall project aims to develop an acceptable and feasible Promotores-delivered intervention program for Hispanic/Latino patients with type 2 diabetes. Specifically, this study aims to conduct a mixed-methods, single arm pre-post intervention pilot trial (6 months) on the Acceptance Based Coping (ABaCo) program to

  • Evaluate feasibility (recruitment and retention) and acceptability (satisfaction)
  • Establish methods of assessing intervention fidelity
  • Engage multi-level partners
  • Estimate the magnitude of potential impact of ABaCo on selected mechanisms and outcomes.

Hypothesis: Participants receiving ABaCo will evidence clinically meaningful change from baseline to follow-up on glycemic management and quality of life (primary outcomes) and self-management skills and acceptance coping (secondary outcomes).

Procedures: Potential participants will be referred to study staff by the Promotores team at the University Health Robert B Green Campus Family Health Center. They will be contacted by study staff for a phone visit to conduct screening procedures. If eligible, they will be scheduled for an in-person visit at the Texas Diabetes Institute (TDI), where they will be consented, complete a fingerstick HbA1c test, and complete an initial assessment packet. Participants will then receive the intervention (telephone-delivered ABaCo skills program) delivered by one Promotor/a for 6 weeks and again at week 10 (booster visit). There will be phone-based assessments visit at week 6, and again at week 10. They will be invited to participate in an interview to provide feedback on their experiences in the program and study. A final in-person assessment at TDI will be conducted at 24 weeks (6 months) after baseline, including a fingerstick HbA1c test and a final assessment packet.

At the study conclusion, all engaged Promotores and clinical partners will also be invited to share their experiences via written and verbal feedback.

Conditions
Type 2 Diabetes
Being tested
Acceptance Based Coping (ABaCo)
Keywords
community health worker, acceptance and commitment therapy, task shifting, access to care
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)Behavioural

    The educational ABaCo protocol consists of core Acceptance \& Commitment Therapy (ACT) interventions, culturally and contextually-tailored for this population, and in accordance with clinician-led versions of ACT for diabetes to include (a) identification of patient values, (b) teaching acceptance and brief mindfulness skills, and (c) techniques for engaging in valued activities while coping with difficult experiences (e.g., sugar cravings, distress). It is delivered by a community health worker (promotor/a) over 6 consecutive weeks over the phone, followed by a booster call at week 10.

Study groups in NCT06445725
Study groupRoleWhat they receive
Acceptance Based Coping (ABaCo) Skills TrainingExperimentalParticipant-patients will receive care as usual in the Nosotros Promotores program at University Health Robert B Green Campus Family Health Center, including standardized procedures (e.g., home visits, phone calls and in-clinic visits), along with this protocol - individual telephone-delivered ABaCo skills intervention delivered by one Promotor/a for 10 weeks (6 weeks plus booster at 10 weeks).
Receives: Behavioral: Acceptance Based Coping (ABaCo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average blood glucose management (HbA1c)

    Glycated hemoglobin (HbA1c) is the average blood glucose levels in past 3 months (HbA1c); higher percentages reflect higher levels of blood glucose (worse blood glucose management).

    Measured: 0, 24 weeks

  2. Quality of life: Patient Reported Outcomes Measurement Information System Global-10

    PROMIS-10 consists of 10 items that assess physical and mental health, functioning, emotional distress, interference, overall quality of life. There are two subscales - Global Physical Health and Global Mental Health. The raw score range for both subscales is 4 to 20, but raw scores are converted to T-scores with a range of 20-80. Higher scores indicate better health. Strong psychometrics.

    Measured: 0, 6, 10, 24 weeks

Secondary outcomes (5)

  1. Diabetes Acceptance: Acceptance & Action Diabetes Questionnaire (AADQ)

    11 Likert-type items (1-7): acceptance of distressing diabetes thoughts/feelings and their interference. The range of possible scores is 11-77; higher scores indicate greater non-acceptance of diabetes. Good internal consistency, construct and discriminant validity.

    Measured: 0, 6, 10, 24 weeks

  2. Diabetes Acceptance: Diabetes Acceptance Scale (DAS)

    DAS is a recently-developed 20-item measure with Likert scale items (1-3) that identifies patients struggling to accept diabetes. Items 11 - 20 are reversed scored. The lowest possible score is 0, and the highest possible score is 60. Higher scores indicate greater diabetes acceptance. It will be used with the AADQ in pilot testing to inform best measures for next trial.

    Measured: 0, 6, 10, 24 weeks

  3. Self-management: Summary of Diabetes Self-Care Activities

    11-item scale assesses five different self-care regimen areas: Diet, exercise, blood-glucose testing, foot care, and smoking. The items are measured by days of the week on a scale of 0-7. The total score range is 0 -77. Higher scores indicate better self-care.

    For the general diet score, the mean is taken for items 1 and 2. For specific diet, the mean for items 3 and 4 is taken, with item 4 being scored reversed.

    For exercise scoring the mean is taken for items 5 and 6. Blood glucose is scored by taking the mean for items 7 and 8. While foot care is measured by taking the mean of items 9 and 10. Smoking is measured by item 11 and the number of cigarettes smoked per day.

    Established, standardized.

    Measured: 0, 6, 10, 24 weeks

  4. Diabetes Distress: Diabetes Distress Scale

    17 Likert-type scale items (1-6) measure diabetes-related distress with subscales of Emotional Burden, Physician Distress, Regimen Distress, and Interpersonal Distress. Total scores range from 17 -102, but an average score is calculated to determine level of distress, with higher scores indicating greater distress. An average score of < 2 reflects little to no distress, an average score between 2. and 2.9 reflects moderate distress, and an average score of > 3 reflects high distress. Strong psychometrics.

    Measured: 0, 6, 10, 24 weeks

  5. Emotional Distress: Patient Health Questionnaire-4

    4-item Likert scale measure (0-3). It is an ultra-brief screener that assesses anxiety and depression. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). A total score greater than or equal to 3 on the first two questions suggests anxiety, while a total score greater than or equal to 3 on the last two questions suggests depression. Good psychometric properties.

    Measured: 0, 6, 10, 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2024
  2. Study start4 Mar 2024
  3. Primary completion24 Mar 2025
  4. Study completion24 Mar 2025

Resources

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
Not applicable
Intervention model
Single group
Model description
single arm, pre-post, mixed-methods pilot study
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06445725
Sponsor's protocol ID
H-54317
Other IDs
7K23DK123398
Acronym
ABaCo
Status last verified
Aug 2025
First submitted
18 Apr 2024
Last updated
26 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Based on ethical considerations, the following data produced during the project will be preserved and shared: deidentified standardized survey data; clinical data (i.e., lab values); recruitment and retention counts; qualitative data (aggregated matrix of interview responses). To facilitate the interpretation of the data, metadata, including protocols and public data collection instruments, will be available and associated with the relevant datasets.

Publications

  • Gregg JA, Callaghan GM, Hayes SC, Glenn-Lawson JL. Improving diabetes self-management through acceptance, mindfulness, and values: a randomized controlled trial. J Consult Clin Psychol. 2007 Apr;75(2):336-43. doi: 10.1037/0022-006X.75.2.336.

    PubMed 17469891

  • Schmitt A, Reimer A, Kulzer B, Icks A, Paust R, Roelver KM, Kaltheuner M, Ehrmann D, Krichbaum M, Haak T, Hermanns N. Measurement of psychological adjustment to diabetes with the diabetes acceptance scale. J Diabetes Complications. 2018 Apr;32(4):384-392. doi: 10.1016/j.jdiacomp.2018.01.005. Epub 2018 Jan 31.

    PubMed 29439862

  • Barnett ML, Lau AS, Miranda J. Lay Health Worker Involvement in Evidence-Based Treatment Delivery: A Conceptual Model to Address Disparities in Care. Annu Rev Clin Psychol. 2018 May 7;14:185-208. doi: 10.1146/annurev-clinpsy-050817-084825. Epub 2018 Jan 31.

    PubMed 29401043

  • Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.

    PubMed 32175717

  • American Diabetes Association. Standards of Medical Care in Diabetes-2018 Abridged for Primary Care Providers. Clin Diabetes. 2018 Jan;36(1):14-37. doi: 10.2337/cd17-0119. No abstract available.

    PubMed 29382975

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance Based Coping (ABaCo) 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 26 Aug 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average blood glucose management (HbA1c) (time frame: 0, 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?

On the ClinicalTrials.gov record for NCT06445725, which also lists 5 linked publications.

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 26 Aug 2025.

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