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

Not Applicable

Completed

• Conditions: Pre-diabetes
• Interventions: Behavioral: Receive lifestyle modification alone; Behavioral: Metformin therapy

• Registration Number: NCT04343872
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-13
• Study Start: 2020-12-10
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Results First Submitted: 2024-01-01
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Results First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Receive lifestyle modification alone (DPP)	Receive lifestyle modification alone	Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services
Receive lifestyle modification with metformin therapy	Receive lifestyle modification alone	Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation
Receive lifestyle modification with metformin therapy	Metformin therapy	Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	12 months	Change in body weight from baseline to 12-months
Change in Glycosylated Hemoglobin (HbA1c)	12 months	Change in glycosylated hemoglobin (HbA1c) point of care test values

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States