RecruitingNot ApplicableNCT06028503

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


Sponsor

Sam Houston State University

Enrollment

60 participants

Start Date

Apr 1, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether Acceptance and Commitment Therapy (ACT) — a type of mindfulness-based talk therapy — delivered via a smartphone app can help people with type 2 diabetes in rural and underserved communities better manage their condition. The study focuses on emotional coping and behavior change to support blood sugar control. **You may be eligible if...** - You are 18 or older and live in a rural area (based on your zip code) - You have been diagnosed with type 2 diabetes with an HbA1c of 6.0 or higher - You can speak English and have reliable access to a smartphone **You may NOT be eligible if...** - You reported thoughts of suicide at your initial visit - You have signs of serious mental illness (acute psychosis) or significant cognitive impairment - You use alcohol or substances heavily - You are pregnant - You have a pacemaker or other implanted electrical medical device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAcceptance 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

DEVICEAbbott 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.

OTHERGeneric 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.


Locations(1)

Sam Houston State University College of Osteopathic Medicine

Conroe, Texas, United States

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NCT06028503


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