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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 15, 2025 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Aug 31, 2025 to Aug 31, 2026
    • Study completion date: Aug 31, 2026 to Aug 31, 2027
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  3. Notable Start date: Jan 15, 2024 to Apr 1, 2024v3
  4. Notable Start date: Sep 1, 2023 to Jan 15, 2024v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06028503
Lead Sponsor Sam Houston State University
Collaborators: Chelsea Ratcliff, Ph.D., Owen Kelly, Ph.D.,RNutr, Oluwaseun Olaiya, DO, Michael Griffin, Ph.D.
Conditions
(from sponsor)
Type 2 Diabetes
Related terms Diabetes Mellitus, Type 2
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov