RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effectiveness of a Community-Based Intervention of Acceptance and Commitment Therapy for Type 2 Diabetes Management in a Rural and Underserved Community

Quick Facts

Study Start:2024-04-01
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06028503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosed diabetes (self-reported) and with an HbA1c ≥ 6.0 (using point-of-care device)
  2. 2. at least 18 years of age or older
  3. 3. able to speak English
  4. 4. able to provide informed consent and participate in the study
  5. 5. reliable access to a personal smartphone device 6) zip code is associated with a rural area.
  1. 1. Reported suicidal ideation at the initial visit
  2. 2. has evidence of acute psychosis that precludes informed consent
  3. 3. appears to be cognitively impaired to the extent that precludes informed consent
  4. 4. uses a heavy amount of alcohol or other substances
  5. 5. is deemed by the multidisciplinary study team has too medically complex for a more conservative treatment approach
  6. 6. has a pacemaker or other implanted electrical medical device
  7. 7. Pregnant (management of diabetes while pregnant may require additional medical oversight).
  8. 8. Under 18 years old (protocol was validated for adults)
  9. 9. Non-English-speaking individuals (protocol has not been translated and validated in other languages)

Contacts and Locations

Study Contact

Ryan J Marek, Ph.D.
CONTACT
(936)294-3614
rxm147@shsu.edu
Chelsea Ratcliff, Ph.D.
CONTACT
(936)294-4662
chelsea.ratcliff@shsu.edu

Study Locations (Sites)

Sam Houston State University College of Osteopathic Medicine
Conroe, Texas, 77304
United States

Collaborators and Investigators

Sponsor: Sam Houston State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Type 2 Diabetes