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

NCT ID: NCT06028503

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-08-31

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.

Detailed Description

ADA guidelines highlight the essential role of nutrition therapy and/or diabetes self-management education (DSME) programs in diabetes management. A recent NHANES analysis which included 2365 people with diabetes indicated that only 32% are considered in good control of diabetes (HbA1c 6.5-6.9%). In the rural community at higher risk of diabetes, conventional lifestyle intervention approaches to diabetes management (e.g., Look AHEAD) or prevention, are not sustainable as they are resource intense. In medical deserts such as rural areas, there is a need for alternative strategies. To add, a mechanism that can impact lack of behavioral adherence is experiential avoidance. Experiential avoidance describes avoiding or escaping behaviors that cause B. distress, anxiety, shame, guilt, pain, and others. Acceptance and Commitment Therapy (ACT) targets experiential avoidance, which many believe prevents engagement in health behavior change. ACT has demonstrated efficacy in numerous psychological and biomedical diseases, including depression and anxiety, migraines, chronic pain, inflammatory bowel disease, weight loss, and T2D. ACT helps patients to overcome avoidance of health behaviors by promoting acceptance of negative feelings and thoughts and by encouraging them to engage in behaviors that align well with their values. Although dietary data suggest people with diabetes may be making self-perceived positive dietary changes, experiential avoidance likely prohibits sustained food behavior change and better self-management.

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.

Specific aims:

Aim 1: To implement and adapt (to include CGM monitoring) an abbreviated (one day session) ACT protocol for T2D8 that we can administer at the group level to rural individuals. By the end of the one-day workshop, participants should understand how to use acceptance skills (e.g., mindfulness, cognitive defusion from negative thoughts) to engage in committed action towards T2D management and adherence. Two clinical psychologists, with input from the multidisciplinary team, will adapt the protocol and participant worksheets from existing brief ACT interventions for T2D.

Aim 2: To conduct a pilot single-blind randomized control trial of an adapted ACT for T2D, in combination with CGM and LE, to evaluate the feasibility, acceptability and initial efficacy of this protocol at a among in rural individuals. Therefore, this study will compare the efficacy of ACT+CGM+LE to CGM+LE, or LE alone, on hemoglobin HbA1c in 60 people with T2D recruited from a rural population.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acceptance and Commitment Therapy

Intervention Type: BEHAVIORAL

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

Intervention Type: DEVICE

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

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Abbott FreeStyle® Libre® 3

Intervention Type: DEVICE

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

Intervention Type: OTHER

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.

Lifestyle Education (LE)

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.

Group Type: ACTIVE_COMPARATOR

Generic Education

Intervention Type: OTHER

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.

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chelsea Ratcliff, Ph.D.

UNKNOWN

Sponsor Role: collaborator

Owen Kelly, Ph.D.,RNutr

UNKNOWN

Sponsor Role: collaborator

Oluwaseun Olaiya, DO

UNKNOWN

Sponsor Role: collaborator

Michael Griffin, Ph.D.

UNKNOWN

Sponsor Role: collaborator

Sam Houston State University

OTHER

Sponsor Role: lead

Responsible Party

Ryan J Marek, Ph.D.

Assistant Professor of Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sam Houston State University College of Osteopathic Medicine

Conroe, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan J Marek, Ph.D.

Role: CONTACT

rxm147@shsu.edu

(936)294-3614

Chelsea Ratcliff, Ph.D.

Role: CONTACT

chelsea.ratcliff@shsu.edu

(936)294-4662

Facility Contacts

Ryan J Marek, Ph.D.

Role: primary

rxm147@shsu.edu

936-294-3614

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

IRB-2023-194

Identifier Type: -

Identifier Source: org_study_id