ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community
Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community
Sam Houston State University
60 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria9
- 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)
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Interventions
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
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06028503