Status:
RECRUITING
ACT Intervention for Type 2 Diabetes Management for Rural and Underserved Community
Lead Sponsor:
Sam Houston State University
Collaborating Sponsors:
Chelsea Ratcliff, Ph.D.
Owen Kelly, Ph.D.,RNutr
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Gluco...
Detailed Description
ADA guidelines highlight the essential role of nutrition therapy and/or diabetes self-management education (DSME) programs in diabetes management. A recent NHANES analysis which included 2365 people w...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06028503
Start Date
April 1 2024
End Date
August 31 2027
Last Update
May 15 2025
Active Locations (1)
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1
Sam Houston State University College of Osteopathic Medicine
Conroe, Texas, United States, 77304