The Dietary Guidelines 3 Diet Patterns Study (DG3D): Phase 2

NCT05254496 | Active Not Recruiting DMC

• 1 other identifier: Pro00118661
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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

Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Changes in dietary quality

  Changes in dietary quality as assessed by the Healthy Eating Index

  12 months

• Changes in body weight

  Changes in body weight

  12 months

• Changes in HgbA1c

  Changes in HgbA1c

  12 months

Secondary Outcomes (1)

• Changes in blood pressure

  12 months

Study Arms (3)

US Healthy Diet

EXPERIMENTAL

Participants in this group will be assigned to follow the Healthy US dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern is based on the types and amounts of foods Americans typically consume. The main types of food in this eating pattern include a variety of vegetables; fruits; whole grains; fat-free or low-fat dairy; seafood, poultry, meat, and eggs; and nuts, seeds, and soy products.

Behavioral: Dietary Intervention Classes

Mediterranean diet

EXPERIMENTAL

Participants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern.

Behavioral: Dietary Intervention Classes

Vegetarian diet

EXPERIMENTAL

Participants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains no meat, poultry, or seafood. Compared with the Healthy U.S.-Style Eating Pattern, it contains more soy products, eggs, beans and peas, nuts and seeds, and whole grains.

Behavioral: Dietary Intervention Classes

Interventions

Dietary Intervention Classes BEHAVIORAL

Participants will attend classes once per week for 6 months and then bi-weekly for 6 months.

Mediterranean diet; US Healthy Diet; Vegetarian diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

• Bailey S, Turner-McGrievy GM, Keseko EA, Duncan T, Ward-Johnson D, Davis B, Wilcox S, Friedman DB, Sarzynski MA, Liese AD. The Diet Guidelines: 3 Diets (DG3D) study protocol of a behavioral teaching kitchen intervention for type-2 diabetes prevention among African American adults. Contemp Clin Trials. 2025 Dec;159:108109. doi: 10.1016/j.cct.2025.108109. Epub 2025 Oct 10.

  PMID: 41077220 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to participant group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: February 24, 2022
• Study Start: April 4, 2022
• Primary Completion: December 30, 2025
• Study Completion: March 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)