Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.

Study Overview
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Brief Summary
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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.

Detailed Description
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The pilot trial in aim three will include enrolling four primary care practices. Each of the participating practices will be randomized to one of two arms and accordingly enrolled participants from each clinic will be assigned to one of two conditions: Condition 1. Receive lifestyle modification alone (Diabetes Prevention Program (DPP). Condition 2. Receive lifestyle modification (DPP) with metformin therapy recommendation. Twenty five participants will be enrolled from each participating practice. Participants will be followed up for 12-14 months after recruitment.

Official Title
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UAB Diabetes Research Center (DRC): Chronic Disease and the Reduction of Health Disparities Supplement

Conditions
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Pre-diabetes

Intervention / Treatment
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* Behavioral: Receive lifestyle modification alone
* Behavioral: Metformin therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 to 59 years Body mass index (BMI) ≥35 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Receive lifestyle modification alone (DPP)<br>Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services | Behavioral: Receive lifestyle modification alone<br>* Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone.<br>|
| Experimental: Receive lifestyle modification with metformin therapy<br>Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation | Behavioral: Receive lifestyle modification alone<br>* Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone.<br>Behavioral: Metformin therapy<br>* The two other clinics will be randomized to receive the lifestyle intervention program (described above) with METFORMIN therapy recommendations. Participants are randomized at the practice level. The primary care provider at the clinic will prescribe metformin and participants would be encouraged to take it if the primary care provider consider prescribing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in body weight | Percent change in body weight | 12 months | 
| Change in Glycemia | Percent change in Hemoglobin A1C test values | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Metformin Therapy