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Completed NCT04981847

The Dietary Guidelines 3 Diets Study

Conditions: Type 2 Diabetes

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 63
Sponsor: University of South Carolina

Location: University of South Carolina Columbia South Carolina

Summary

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

Inclusion Criteria: * 18-65 years of age * BMI between 25- 49.9 kg/m2 * self-identify as African American * live in the Columbia, SC area * be able to attend all monitoring visits * be willing to be randomized to either condition and be re-randomized if non-responsive * 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 24 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04981847). StuddyBuddy aggregates publicly available trial information.