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
1 other identifier
interventional
60
1 country
1
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 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Apr 2024
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
May 15, 2025
May 1, 2025
2.4 years
July 31, 2023
May 12, 2025
Conditions
Outcome Measures
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.
1-year
Secondary Outcomes (7)
Body Mass Index
1-year
Body Composition
1-Year
Experiential Avoidance
1-Year
Depression
1-Year
Adherence
1-Year
- +2 more secondary outcomes
Study Arms (3)
Acceptance and Commitment Therapy + Continuous Glucose Monitoring + Lifestyle Education (ACT+CGM+LE)
EXPERIMENTALParticipants assigned to ACT+CGM+LE will have both of the above modules in addition to three ACT modules based on Gregg et al.8 and traditional ACT therapy19. Two facilitators will lead the ACT sessions: Dr. Marek or Dr. Ratcliff and one trained doctoral-level clinical psychology student under their direct supervision (i.e., one licensed provider paired with a student). We will run all sessions in a group format. Participants will be given breaks between modules and one long lunch break.
Continuous Glucose Monitoring + Lifestyle Education (CGM+LE)
EXPERIMENTALParticipants assigned to CGM+LE will attend the group LE workshop. CGM training will occur after the 5 hour lifestyle education delineated above (same content, but less informal discussion). This will include training on using blood glucose monitoring devices, setting up the App on the smartphone (including activating the hypoglycemic alarm) and how to apply the glucose sensors on the arm. If a sensor does fall off a participant, a member of the study team will provide a spare sensor to the participant. The glucose range for participants will be set at between 70 and 140 mg/dL, unless the study physician (Dr. Olaiya) determines otherwise. The CGM device will allow us to calculate the percentage of 'time in range' per day, peak glucose, nocturnal glucose and number of hypoglycemic events. The CGM training will be managed by Dr. Olaiya and/or Dr. Kelly, and a medical/dietetic students.
Lifestyle Education (LE)
ACTIVE COMPARATORParticipants 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.
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sam Houston State Universitylead
- Chelsea Ratcliff, Ph.D.collaborator
- Owen Kelly, Ph.D.,RNutrcollaborator
- Oluwaseun Olaiya, DOcollaborator
- Michael Griffin, Ph.D.collaborator
Study Sites (1)
Sam Houston State University College of Osteopathic Medicine
Conroe, Texas, 77304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The RC will have a shuffled stack of envelopes with a group assignment in each. As participants meet inclusion into the study, their information, including Study ID, will be placed in one of the shuffled envelopes. The envelope will be placed in another envelope and sealed. Once approximately 10 participants are randomized to each group, the RC will contact all participants who have been randomized to share the date and time of the intervention and ask them to complete the 30-minute baseline surveys comprised of self-report measures (located in measures section) that they will receive by email. If recruitment slows down, we will do the randomization once 5 participants express interest in the study. The RC will then send a unique Qualtrics link to each participant (to prevent participants from needing to enter identifying information on the survey). The baseline self-report survey is described below in the Measures section.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Psychology
Study Record Dates
First Submitted
July 31, 2023
First Posted
September 8, 2023
Study Start
April 1, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- We will adhere to all polices in the repository that will accept our data. Data will become available once primary outcome data is analyzed by the study team and reported or when the repository requires - whichever comes first.
We plan to place the data in an open data repository. We intend to reach out NIH's NIDDK's data repository to determine if they will let us store our data there to promote openness and transparency.