Social Determinants and a Diabetes Prevention Program Tailored for African Americans
African Americans (AAs) have rates of diabetes mellitus (DM) twice that of Whites and are disproportionately affected by leading risk factors for DM - obesity and low-income. A critical strategy in the battle against DM is the Diabetes Prevention Program (DPP), an evidence-based intervention that significantly delays or prevents Type 2 diabetes through the promotion of diet change, exercise and modest weight loss. However, weight loss from the DPP among AAs is about half that of White participants, and suboptimal AA attendance is a critical contributor. The investigators propose to conduct a study that will address social determinants (SD) that challenge DPP attendance with underserved African Americans from a safety net hospital. The investigators will examine DPP attendance and weight loss with participants randomized to 3 groups: standard DPP, a culturally-tailored DPP to address acceptability, and a culturally-tailored DPP enhanced to address socioeconomic-related barriers to DPP participation. This novel study is the first to tailor the DPP to address SD cultural and socioeconomic barriers that limit DPP attendance and reduce its effectiveness on outcomes. The proposed multidimensional, SD tailored DPP has great potential to be a feasible and scalable model to reduce DM risks among urban, African Americans and ultimately reduce DM disparities.
Conditions:
🦠 PreDiabetes 🦠 Overweight and Obesity
🗓️ Study Start (Actual) 20 July 2022
🗓️ Primary Completion (Estimated) 31 October 2025
✅ Study Completion (Estimated) 31 October 2025
👥 Enrollment (Estimated) 360
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Kansas City, Missouri, United States
📍 Kansas City, Missouri, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Black/African American
    • * Overweight (\[BMI\> 24); and
    • * Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test

    Exclusion Criteria:

    • * Diagnosed with diabetes
    • * Pregnant
    • * Not fluent in English
    • * Currently pregnant, planning a pregnancy in the next year, currently breastfeeding or have given birth in the last 6 months
    • * Currently participating in a weight loss program
    • * Currently have a medical condition that causes drastic weight loss
    • * Bariatric weight loss surgery in last year
    • * Cannot walk a 1-block distance without assistance and without stopping due to pain, tightness, or pressure in the chest
    • * Had heart failure
    • * Not willing to use a fitness tracker, wi-fi scale, and the internet
    • * Not available in the evening one day each week to participate in a class
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 9 March 2022
  • First Submitted that Met QC Criteria 28 March 2022
  • First Posted 29 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 April 2024
  • Last Update Posted 8 April 2024
  • Last Verified April 2024