Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05254496

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersAccepted
ConditionDiabetes Mellitus, Type 2, Obesity

Full registry criteria

Inclusion Criteria: * 18-70 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 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 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)

Treatments and study arms

Dietary Intervention Classes

Behavioral

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

Primary outcomes

Changes in dietary quality12 months

Changes in dietary quality as assessed by the Healthy Eating Index

Changes in body weight12 months

Changes in body weight

Changes in HgbA1c12 months

Changes in HgbA1c

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of South Carolina🇺🇸 Columbia, South Carolina, United States