Dietary Intervention for Type 2 Diabetes

(DG3D Trial)

Overseen By Brie Turner-McGrievy, PhD, MS, RD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of South Carolina

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this project is to use a two-stepped study to examine both the adoption of the three dietary patterns as presented by the United States Dietary Guidelines (USDG) and testing of a refined, culturally tailored one-year intervention examining the three diet patterns. For this study, African American adult participants with overweight/obesity and ≥three type 2 diabetes (T2DM) risk factors will be recruited to participate in this two-step study. This present study is for our Step 1: formative pilot work to culturally-tailor a dietary intervention of the three healthy eating patterns presented by the USDG for 12 weeks: 1) U.S.-Style, 2) Mediterranean, or 3) Vegetarian.

Eligibility Criteria

This trial is for African American adults living in Columbia, SC with overweight/obesity and at least three risk factors for type 2 diabetes. Participants should be aged 18-65, have a BMI of 25-49.9, and not suffer from major diseases or conditions like thyroid issues or diabetes. They must commit to attending all sessions and accept random diet assignments.

Inclusion Criteria

Live in the Columbia, SC area

Be willing to be randomized to either condition and be re-randomized if non-responsive

I am between 18 and 65 years old.

Exclusion Criteria

I am not in a weight loss program nor taking weight loss medications.

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)

I have not lost more than 10 pounds in the last 6 months.

Treatment Details

Interventions

• Dietary Intervention Meetings (Behavioral Intervention)

Trial Overview The study tests the adoption of three diets based on U.S. Dietary Guidelines over a period of 12 weeks: U.S.-Style, Mediterranean, or Vegetarian. The aim is to tailor these diets culturally for African Americans at risk of type 2 diabetes.

Participant Groups

Group I: Vegetarian diet Experimental Treatment 1 Intervention

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.

Group II: US Healthy Diet Experimental Treatment 1 Intervention

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.

Group III: Mediterranean diet Experimental Treatment 1 Intervention

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. There is also less calcium and vitamin D because it includes fewer dairy foods.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+