Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach… (NCT04343872) | Clinical Trial Compass
CompletedNot Applicable
Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.
United States36 participantsStarted 2020-12-10
Plain-language summary
Diabetes is responsible for a huge and growing burden of patient suffering and social costs, and the impact of this disease is shared disproportionately by minorities and in rural resource-challenged communities, particularly in the Deep South. To address this problem, the University of Alabama (UAB) Diabetes Research Center (DRC) will establish a primary care clinical network in rural counties of Alabama and in the Mississippi delta that will provide the (DRC) and its members with opportunities for partnership and the infrastructure to conduct translational and clinical research in those patients with the greatest need. A pilot trial will be conducted within the coalition to assess feasibility for a larger trial to evaluate a novel and sustainable approach for diabetes prevention that involves an innovative lifestyle intervention combined with metformin.
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 19 to 65 years
* Body mass index (BMI) ≥30
* Receives care at one of the participating primary care clinics
* HbA1c 6.0% to 6.4%
* Resides in one location at least 5 days each week
* Willing to attend group-based classes
* Willing to work with a peer advisor in-person and over the phone
* Has regular access to telephone or cellular phone
* Willing and able to use telemonitoring body weight to conduct daily self-weighing
* Estimated Glomerular Filtration Rate (eGFR) of ≥60 in their medical record within 6 months
Exclusion Criteria:
* Diabetes diagnosis or HbA1c \>6.4% or fasting glucose ≥126
* HbA1c \<6.0%
* Pregnancy or anticipating pregnancy
* Unwilling or unable to do any of the following: give informed consent, accept random assignment, allow study staff to visit them at their primary care clinic for two follow-up visits
* Likely to relocate within next 6 months and no longer be seen at clinic within the next 12 months
* Weight loss ≥5% of body weight in past 6 months (other than postpartum)
* Past bariatric surgery
* Prescription weight loss medications within the past 6 months
* eGFR \< 60 within past 6 months
* Unable to ambulate
* Have end-stage medical conditions with limited life expectancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.