NCT06028503 · Sam Houston State University
ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community
What this study is about
The purpose of this project is to examine the feasibility/acceptability of a one-day Acceptance and Commitment Therapy + Lifestyle Education group intervention paired with 12-weeks of Continuous Glucose Monitoring for patients with type 2 diabetes (T2D) living in rural communities. This study is being designed as a randomly assigned control trial (RCT) comparing ACT+LE+CGM to LE+CGM to LE.
View original scientific description
The purpose of this project is to examine the feasibility/acceptability of a one-day Acceptance and Commitment Therapy + Lifestyle Education group intervention paired with 12-weeks of Continuous Glucose Monitoring for patients with type 2 diabetes (T2D) living in rural communities. This study is being designed as a randomized control trial (RCT) comparing ACT+LE+CGM to LE+CGM to LE. The ultimate goal of this line of research is that a community-wide intervention of Acceptance and Commitment Therapy (ACT) with Continuous Glucose Monitoring (CGM) and Lifestyle Education (LE) will improve T2D outcomes in rural communities compared to CGM and LE, or LE alone. Our goal is to develop a scalable and sustainable program for diabetes management in rural areas that enables individual self-management and does not require extensive healthcare resources in an existing medical desert.
Interventions
BEHAVIORAL
Acceptance and Commitment Therapy
Approximately 3 hours of ACT will be administered based on Gregg et al.;s (2007) protocol: 1. What is ACT? 2. Coping and Stress Management 3. Acceptance and Action
DEVICE
Abbott FreeStyle® Libre® 3
The Abbott FreeStyle® Libre® 3 (FDA approved) consists of a single use disposable electrochemical sensing unit which is placed on the upper arm and an App for smart phones where the participant can view their glucose data, including their current glucose reading, their 'trend arrow' so participants can see how glucose is changing, and their glucose history. The FreeStyle system does not require user calibration. A sensor log will be maintained for accountability of all sensors received as well as used sensors (including the lot/serial number, expiration date, and the date). Sensors will be stored at manufacturers recommendations.
OTHER
Generic Education
Participants will be given information about how lifestyle choices, including daily dietary choices, affect blood sugar for people with T2D, and best practices related to checking blood sugar and carbohydrate counting if participants are on insulin therapy. These sessions will also include education on diabetes nutrition guidelines and improving self-management through better food and lifestyle choices.
Primary outcome measures
Reduction in Hemoglobin A1C
Time frame: 1-year
Our goal is to determine if CGM and ACT can change HbA1c 3 months after the intervention and to determine if those reductions can be sustained one year after the intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosed diabetes (self-reported) and with an HbA1c ≥ 6.0 (using point-of-care device)
- at least 18 years of age or older
- able to speak English
- able to provide informed consent and participate in the study
- reliable access to a personal smartphone device 6) zip code is associated with a rural area.
Exclusion criteria
- Reported suicidal ideation at the initial visit
- has evidence of acute psychosis that precludes informed consent
- appears to be cognitively impaired to the extent that precludes informed consent
- uses a heavy amount of alcohol or other substances
- is deemed by the multidisciplinary study team has too medically complex for a more conservative treatment approach
- has a pacemaker or other implanted electrical medical device
- Pregnant (management of diabetes while pregnant may require additional medical oversight).
- Under 18 years old (protocol was validated for adults)
- Non-English-speaking individuals (protocol has not been translated and validated in other languages)
Where
- Conroe, Texas
Collaborators
Chelsea Ratcliff, Ph.D., Owen Kelly, Ph.D.,RNutr, Oluwaseun Olaiya, DO, Michael Griffin, Ph.D.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 15, 2025 · Source of record for eligibility and locations