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

Obesity Clinical Trial

— DG3D-Phase2  

Official title:

Ensuring the Cultural Relevance of Dietary Guidelines Diet Patterns Among African Americans: Increasing Dietary Quality and Reducing Type 2 Diabetes Risk (Phase 2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254496
• Other study ID #: Pro00118661
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2023
• Source: University of South Carolina
• Contact: Mary Wilson, PhD
• Phone: 803-777-1902
• Email: NEWSOUL[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

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 focus on individual nutrients to a greater focus on dietary patterns. The USDG state that healthy eating goals can be met through a variety of dietary patterns, but present healthy diet in three main ways: 1) Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern. Currently, US adults are falling short of the nutrition recommendations (fruit/vegetable intake, greens/beans, whole grains, etc.) set forth by the USDG and measured by the Healthy Eating Index (HEI). While the USDG are the basis of nutrition guidelines, the research informing these dietary pattern recommendations has largely been drawn from observational studies among mostly white populations. In addition, there has been very limited cultural-tailoring of these dietary patterns that would ensure that these diets are acceptable to diverse populations, in particular, African Americans (AAs) living in the south, who experience a disproportionate burden of chronic disease, especially type 2 diabetes (T2DM). Currently, US adults are not meeting nutrition recommendations (fruit/vegetable, whole grains, etc.) set forth by the USDG and measured by the Healthy Eating Index (HEI). For this study, AA adult participants with overweight/obesity and ≥three T2DM risk factors will be recruited to participate in the following aim: Based on the findings of our formative work, conduct a one-year intervention using revised culturally tailored materials to examine differences in HEI and T2DM risk factors among participants (n=198) randomized to one of the 3 dietary patterns. This will result in community-based strategies around presenting dietary guidelines in a way to effectively meet nutrition recommendations leading to significant impacts on health among AA adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Behavioral:
• Dietary Intervention Classes
Participants will attend classes once per week for 6 months and then bi-weekly for 6 months.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in dietary quality	Changes in dietary quality as assessed by the Healthy Eating Index	12 months
Primary	Changes in body weight	Changes in body weight	12 months
Primary	Changes in HgbA1c	Changes in HgbA1c	12 months
Secondary	Changes in blood pressure	Changes in systolic and diastolic blood pressure	12 months