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Completed

NCT Number: NCT04981847

The Dietary Guidelines 3 Diets Study

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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 the present study, AA adult participants with overweight/obesity and ≥three T2DM risk factors will be recruited to participate in the following aims:

Aim 1: Conduct a 3-month randomized trial among AAs comparing adoption of the 3 dietary patterns [1) US, 2) Med, or 3) Veg] using existing materials from the USDG and examine differences in diet quality (HEI) and T2DM risk factors (weight, HgbA1c).

Aim 2: Drawing on participants' experiences in Aim 1, conduct qualitative work to refine and culturally tailor the dietary pattern intervention for an AA audience.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dietary Intervention Meetings

Behavioral

Participants will attend classes once per week for 3 months.

Primary outcomes

  1. Delta Dietary Quality

    Time frame: From baseline to the end of the intervention at 3 months

    Change in Healthy Eating Index (HEI) total score was calculated as 3-month follow-up score minus baseline score. HEI total scores range from 0 to 100, with higher scores indicating better diet quality and greater adherence to dietary guidelines. The change score could potentially range from -100 to +100. Positive change scores indicate improvement in diet quality, whereas negative change scores indicate worsening diet quality. HEI total scores were calculated from three averaged 24-hour dietary recalls collected at each time point using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA24).

  2. Delta Body Weight

    Time frame: From baseline to the end of the intervention at 3 months

    Change in body weight from baseline to the end of the intervention at 3 months

  3. Delta Hemoglobin A1c

    Time frame: From baseline to the end of the intervention at 3 months

    Change in HgbA1c from baseline to the end of the intervention at 3 months

Secondary outcomes

  1. Delta Systolic Blood Pressure

    Time frame: From baseline to the end of the intervention at 3 months

    Change in systolic blood pressure from baseline to the end of the intervention at 3 months

  2. Delta Diastolic Blood Pressure

    Time frame: From baseline to the end of the intervention at 3 months

    Change in diastolic blood pressure from baseline to the end of the intervention at 3 months

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

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

Acronym: DG3D

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2021
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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