Dietary Interventions for Type 2 Diabetes
(DG3D-Phase2 Trial)

Recruiting in Palo Alto (17 mi)

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?

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.

Research Team

Eligibility Criteria

This trial is for African American adults aged 18-65 living in Columbia, SC with a BMI of 25-49.9 kg/m2 who are not pregnant, breastfeeding, or planning pregnancy soon. Participants should not be on weight loss programs/medications or have had bariatric surgery and must be free from major health issues, eating disorders, drug/alcohol dependency, thyroid conditions, and diabetes.

Inclusion Criteria

You are willing to be randomized to either condition and be re-randomized if non-responsive.

Live in the Columbia, SC area

Be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy

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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

You should not have an eating disorder. If you do, you will be given information to contact a specific clinic for help.

I have not had, nor am I planning to have, weight loss surgery.

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Treatment Details

Interventions

Healthy Mediterranean-Style Eating Pattern (Dietary Intervention)
Healthy U.S.-Style Eating Pattern (Dietary Intervention)
Healthy Vegetarian Eating Pattern (Dietary Intervention)

Trial OverviewThe study tests three different diet patterns over one year to see their effects on healthy eating scores and risk factors for type 2 diabetes: U.S.-Style Eating Pattern, Mediterranean-Style Eating Pattern, and Vegetarian Eating Pattern. Participants will be randomly assigned to one of these diets.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Vegetarian dietExperimental Treatment1 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 DietExperimental Treatment1 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 dietExperimental Treatment1 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.