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

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.

Study Overview

• Status: Completed
• Conditions: Pre-diabetes
• Intervention / Treatment: Behavioral: Receive lifestyle modification alone; Behavioral: Metformin therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 59 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Receive lifestyle modification alone (DPP); Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services	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.
Experimental: Receive lifestyle modification with metformin therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Andrea Cherrington, MD, MPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Metformin Therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: IRB-300005012; 3P30DK079626-12S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No