NCT04343872

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Receive lifestyle modification alone	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.
BEHAVIORAL	Metformin therapy	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.

Timeline

• Start date: 2020-12-10
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-04-13
• Last updated: 2024-03-05
• Results posted: 2024-03-05

Locations

1 site across 1 country: United States