Recruiting

ACT InterventionACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community

Sponsor:

Sam Houston State University

Code:

NCT06028503

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acceptance and Commitment Therapy

Abbott FreeStyle® Libre® 3

Generic Education

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Study ID

NCT06028503

Start date

Apr 1, 2024

Status verified date

May, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosed diabetes (self-reported) and with an HbA1c ≥ 6.0 (using point-of-care device)
2. at least 18 years of age or older
3. able to speak English
4. able to provide informed consent and participate in the study
5. reliable access to a personal smartphone device 6) zip code is associated with a rural area.

Exclusion Criteria:

1. Reported suicidal ideation at the initial visit
2. has evidence of acute psychosis that precludes informed consent
3. appears to be cognitively impaired to the extent that precludes informed consent
4. uses a heavy amount of alcohol or other substances
5. is deemed by the multidisciplinary study team has too medically complex for a more conservative treatment approach
6. has a pacemaker or other implanted electrical medical device
7. Pregnant (management of diabetes while pregnant may require additional medical oversight).
8. Under 18 years old (protocol was validated for adults)
9. Non-English-speaking individuals (protocol has not been translated and validated in other languages)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE)

Participants assigned to ACT+CGM+LE will have both of the above modules in addition to three ACT modules based on Gregg et al.8 and traditional ACT therapy19. Two facilitators will lead the ACT sessions: Dr. Marek or Dr. Ratcliff and one trained doctoral-level clinical psychology student under their direct supervision (i.e., one licensed provider paired with a student). We will run all sessions in a group format. Participants will be given breaks between modules and one long lunch break.

experimental: Continuous Glucose Monitoring + Lifestyle Education (CGM+LE)

Participants assigned to CGM+LE will attend the group LE workshop. CGM training will occur after the 5 hour lifestyle education delineated above (same content, but less informal discussion). This will include training on using blood glucose monitoring devices, setting up the App on the smartphone (including activating the hypoglycemic alarm) and how to apply the glucose sensors on the arm. If a sensor does fall off a participant, a member of the study team will provide a spare sensor to the participant. The glucose range for participants will be set at between 70 and 140 mg/dL, unless the study physician (Dr. Olaiya) determines otherwise. The CGM device will allow us to calculate the percentage of 'time in range' per day, peak glucose, nocturnal glucose and number of hypoglycemic events. The CGM training will be managed by Dr. Olaiya and/or Dr. Kelly, and a medical/dietetic students.

active comparator: Lifestyle Education (LE)

Interventions

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

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.

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 measure

Reduction in Hemoglobin A1C [ Time Frame: 1-year ]

Central Contacts and Locations

Central contacts

Ryan J Marek, Ph.D.

(936)294-3614 rxm147@shsu.edu

Chelsea Ratcliff, Ph.D.

(936)294-4662 chelsea.ratcliff@shsu.edu

Locations

Sam Houston State University College of Osteopathic Medicine

Recruiting

Conroe, Texas, United States, 77304

Contacts

Ryan J Marek, Ph.D.

936-294-3614 rxm147@shsu.edu

More Information

Sponsor

Sam Houston State University

Last update posted

May 15, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sam Houston State University on 2025-05-15.