Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

University of South Carolina

Conditions:

Diabetes Mellitus, Type 2

Obesity

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

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 (H...

Detailed Description

The U.S. Dietary Guidelines (USDG) form the basis of federal nutrition programs and policy and provide valuable guidance to health initiatives and industries. The updated 2015 USDG moved away from a f...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

April 4 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2026

Estimated Enrollment :

198 Patients enrolled

Trial Details

Trial ID

NCT05254496

Start Date

April 4 2022

End Date

March 31 2026

Last Update

December 16 2024

Active Locations (1)

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1

University of South Carolina

Columbia, South Carolina, United States, 29208