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 range19 Years – 65 Years

SexALL

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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

What they're measuring

Change in Body Weight

Timeframe: 12 months

Change in Glycosylated Hemoglobin (HbA1c)

Timeframe: 12 months

Trial details

NCT IDNCT04343872

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2024-01-01