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