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Diabetes Medical Nutrition Therapy in Southeastern African American Women
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.
Conditions:
🦠 Type 2 Diabetes
🗓️ Study Start (Actual) 3 August 2021
🗓️ Primary Completion (Estimated) June 2023
✅ Study Completion (Estimated) June 2023
👥 Enrollment (Estimated) 291
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Nashville, Tennessee, United States
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    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 Criteria:

    • --Observed or diagnosed psychotic disorders
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 July 2021
  • First Submitted that Met QC Criteria 20 July 2021
  • First Posted 22 July 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 August 2022
  • Last Update Posted 24 August 2022
  • Last Verified August 2022
I'm interested ...!!