Clinical Trial

Diabetes Medical Nutrition Therapy in Southeastern African American Women

Active, Not Recruiting
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Summary
A two-arm randomized controlled trial design will be used. Participants will include 291 African American women with type 2 diabetes that are at risk for development and/or progression of diabetes complications. Both arms, diabetes medical nutrition therapy (MNT) and diabetes MNT plus motivational interviewing (MI), will include: 1) a 3-month active intervention period of six biweekly (every other week), group-based, trained nutritionist-facilitated sessions; 2) a 3-month maintenance intervention period, which will include one group-based maintenance support session; and 3) a 6-month inactive period (no contact). The differences between arms is the integration of culturally-adapted MI exercises during the diabetes MNT plus MI active and maintenance intervention periods.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2021-07-20; most recent amendment 2025-12-09.
Status change: Recruiting → Active, Not Recruiting 2025-12-09
Status change: Not Yet Recruiting → Recruiting 2021-08-02
Trial Details
NCT Number NCT04971889
Lead Sponsor Meharry Medical College
Collaborators: Patient-Centered Outcomes Research Institute, Matthew Walker Comprehensive Health Center, Vanderbilt University
Conditions Type 2 Diabetes
Enrollment 291 participants
Start Date 2021-08-03
Primary Completion 2025-10-31 (estimated)
Study Completion 2026-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-17