Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Sam Houston State University College of Osteopathic Medicine
RECRUITING
Conroe
Contact Information
Primary
Ryan J Marek, Ph.D.
rxm147@shsu.edu
(936)294-3614
Backup
Chelsea Ratcliff, Ph.D.
chelsea.ratcliff@shsu.edu
(936)294-4662
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 60
Treatments
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)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Oluwaseun Olaiya, DO, Michael Griffin, Ph.D., Chelsea Ratcliff, Ph.D., Owen Kelly, Ph.D.,RNutr
Leads: Sam Houston State University

This content was sourced from clinicaltrials.gov