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

NCT04343872 | Completed Results

• 2 other identifiers: IRB-3000050123P30DK079626-12S1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

Obesity; Metformin Therapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Receive lifestyle modification alone (DPP)

ACTIVE COMPARATOR

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

Behavioral: Receive lifestyle modification alone

Receive lifestyle modification with metformin therapy

EXPERIMENTAL

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; Behavioral: Metformin therapy

Interventions

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.

Receive lifestyle modification alone (DPP); Receive lifestyle modification with metformin therapy

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.

Receive lifestyle modification with metformin therapy

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

COVID-19 greatly impacted ability to recruit participants and retain participants.

Results Point of Contact

• Title: Dr. Andrea L. Cherrington
• Organization: University of Alabama at Birmingham

acherrington@uabmc.edu

205-996-2885

Study Officials

• Andrea Cherrington, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 13, 2020
• Study Start: December 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)