Skip to main content
OpenTrials
Completed

NCT Number: NCT04343872

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pre-diabetes Body Weight Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB

Birmingham, Alabama, 35205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Receive lifestyle modification alone

Behavioral

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.

Metformin therapy

Behavioral

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 outcomes

  1. Change in Body Weight

    Time frame: 12 months

    Change in body weight from baseline to 12-months

  2. Change in Glycosylated Hemoglobin (HbA1c)

    Time frame: 12 months

    Change in glycosylated hemoglobin (HbA1c) point of care test values

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2020
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.