The Dietary Guidelines 3 Diet Patterns Study (DG3D): Phase 2
Based on the findings of our formative work, conduct a one-year intervention among African American Adults using revised culturally tailored materials to examine differences in Healthy Eating Index (HEI) and type 2 diabetes (T2DM) risk factors among participants (n=198) randomized to one of the 3 dietary patterns: 1) Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern.
Conditions:
🦠 Diabetes Mellitus, Type 2 🦠 Obesity
🗓️ Study Start (Actual) 4 April 2022
🗓️ Primary Completion (Estimated) 30 December 2025
✅ Study Completion (Estimated) 31 March 2026
👥 Enrollment (Estimated) 198
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Columbia, South Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 18-70 years of age
    • * BMI between 25- 49.9 kg/m2
    • * self-identify as African American
    • * live within 150 miles of the Columbia, SC area
    • * be able to attend all monitoring visits
    • * be willing to be randomized to one of the three conditions
    • * be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy

    Exclusion Criteria:

    • * should not be pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 12 months, or currently breastfeeding
    • o Women who are pregnant should not be pursuing weight loss and should be under the direct care of a physician. Therefore women who are pregnant or who are anticipating they might be pregnant should not participate in this study. If a woman becomes pregnant during the study, she will be advised to consult with her healthcare provider and will be dropped from the weight loss study.
    • * should be free of an eating disorder as screened by the Eating disorder Screen for Primary care \[ESP\]. (If a participant has an eating disorder, they will be given contact information for the eating disorder clinic at the University of South Carolina)
    • * no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
    • * no recent or planned bariatric surgery
    • * no recent weight loss (\>10 lbs in the last 6 months)
Ages Eligible for Study: 18 Years to 70 Years (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 23 February 2022
  • First Submitted that Met QC Criteria 23 February 2022
  • First Posted 24 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 June 2024
  • Last Update Posted 24 June 2024
  • Last Verified June 2024