Diabetes Medical Nutrition Therapy in Southeastern African American Women

Last updated: December 19, 2024
Sponsor: Meharry Medical College
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Diabetes MNT

Motivational Interviewing

Clinical Study ID

NCT04971889
21-02-1069
  • Ages > 21
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • African American

  • Female

  • Clinical diagnosis of type 2 diabetes for at least 6 months

  • At risk for development and/or progression of diabetes complications (HbA1c ≥ 7.0%AND either systolic blood pressure ≥130, LDL cholesterol ≥ 100, or BMI ≥ 30).

Exclusion

Exclusion Criteria:

--Observed or diagnosed psychotic disorders

Study Design

Total Participants: 291
Treatment Group(s): 2
Primary Treatment: Diabetes MNT
Phase:
Study Start date:
August 03, 2021
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Matthew Walker Comprehensive Health Center

    Nashville, Tennessee 37208
    United States

    Site Not Available

  • Meharry Medical College

    Nashville, Tennessee 37208
    United States

    Active - Recruiting

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