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

Primary Purpose

Pre-diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receive lifestyle modification alone
Metformin therapy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring Obesity, Metformin Therapy

Eligibility Criteria

19 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UAB

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Receive lifestyle modification alone (DPP)

Receive lifestyle modification with metformin therapy

Arm Description

Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services

Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation

Outcomes

Primary Outcome Measures

Percent change in body weight
Percent change in body weight
Change in Glycemia
Percent change in Hemoglobin A1C test values

Secondary Outcome Measures

Full Information

First Posted
April 7, 2020
Last Updated
October 6, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04343872
Brief Title
Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.
Official Title
UAB Diabetes Research Center (DRC): Chronic Disease and the Reduction of Health Disparities Supplement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Obesity, Metformin Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Receive lifestyle modification alone (DPP)
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services
Arm Title
Receive lifestyle modification with metformin therapy
Arm Type
Experimental
Arm Description
Participants in this arm will receive a lifestyle modification intervention program facilitated by Peer Coach (PC) services plus metformin recommendation
Intervention Type
Behavioral
Intervention Name(s)
Receive lifestyle modification alone
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Metformin therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent change in body weight
Description
Percent change in body weight
Time Frame
12 months
Title
Change in Glycemia
Description
Percent change in Hemoglobin A1C test values
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Cherrington, MD, MPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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