Health TrialsbyHealthPanel

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

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSam Houston State University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Acceptance and Commitment Therapy

    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

    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

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE)Experimental treatment 3 interventions
Group B: Continuous Glucose Monitoring + Lifestyle Education (CGM+LE)Experimental treatment 2 interventions
Group C: Lifestyle Education (LE)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in Hemoglobin A1C

Our goal is to determine if CGM and ACT can change HbA1c 3 months after the intervention and to determine if those reductions can be sustained one year after the intervention.

Time frame
1-year

Secondary outcomes

1

Body Mass Index

Body weight will be measured with the participant in light clothing without shoes. Body height will be measured to the nearest 0.1 cm without shoes using a calibrated stadiometer at screening only. Body weight and height will be used to calculate BMI (BMI = weight/height2 (kg/m2).

Time frame
1-year
2

Body Composition

Waist circumference will be measured at a level midway between the lower rib margin and iliac crest with the tape all around the body in a horizontal position, using a calibrated measuring tape.

Time frame
1-Year
3

Experiential Avoidance

We will assess experiential avoidance with the Acceptance and Action Questionnaire - 2 (AAQ-2) - The AAQ-2 is a reliable and valid self-report measure of psychological flexibility and experiential avoidance.

Time frame
1-Year
4

Depression

We will assess depression via the NIH Patient Report Outcomes Measures Information System (PROMIS) scale for depression. The NIH PROMIS measure for depression has eight items that reliably and validly assess the construct of depression.

Time frame
1-Year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sam Houston State University

Lead sponsor

Chelsea Ratcliff, Ph.D.

Collaborator

Owen Kelly, Ph.D.,RNutr

Collaborator

Oluwaseun Olaiya, DO

Collaborator

Michael Griffin, Ph.D.

Collaborator

Source ClinicalTrials.gov
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