Diabetes Mellitus, Type 2DG3D-Phase2NCT05254496
The Dietary Guidelines 3 Diet Patterns Study (DG3D): Phase 2
A study testing Dietary Intervention Classes in people with Diabetes Mellitus, Type 2 and Obesity, run by University of South Carolina at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Dietary Intervention Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
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)
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:
- Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern.
Read the 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 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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Dietary Intervention Classes
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Intervention ClassesBehavioural
Participants will attend classes once per week for 6 months and then bi-weekly for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| US Healthy Diet | Experimental | Participants in this group will be assigned to follow the Healthy US dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern is based on the types and amounts of foods Americans typically consume. The main types of food in this eating pattern include a variety of vegetables; fruits; whole grains; fat-free or low-fat dairy; seafood, poultry, meat, and eggs; and nuts, seeds, and soy products. Receives: Behavioral: Dietary Intervention Classes |
| Mediterranean diet | Experimental | Participants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern. Receives: Behavioral: Dietary Intervention Classes |
| Vegetarian diet | Experimental | Participants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains no meat, poultry, or seafood. Compared with the Healthy U.S.-Style Eating Pattern, it contains more soy products, eggs, beans and peas, nuts and seeds, and whole grains. Receives: Behavioral: Dietary Intervention Classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dietary quality
Changes in dietary quality as assessed by the Healthy Eating Index
Measured: 12 months
Changes in body weight
Changes in body weight
Measured: 12 months
Changes in HgbA1c
Changes in HgbA1c
Measured: 12 months
Secondary outcomes (1)
Changes in blood pressure
Changes in systolic and diastolic blood pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start4 Apr 2022
- Primary completion30 Dec 2025
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254496
- Sponsor's protocol ID
- Pro00118661
- Acronym
- DG3D-Phase2
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bailey S, Turner-McGrievy GM, Keseko EA, Duncan T, Ward-Johnson D, Davis B, Wilcox S, Friedman DB, Sarzynski MA, Liese AD. The Diet Guidelines: 3 Diets (DG3D) study protocol of a behavioral teaching kitchen intervention for type-2 diabetes prevention among African American adults. Contemp Clin Trials. 2025 Dec;159:108109. doi: 10.1016/j.cct.2025.108109. Epub 2025 Oct 10.
PubMed 41077220
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05254496
- Acronym / sponsor ID
- DG3D-Phase2 / Pro00118661
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Healthy U.S.-Style Eating Pattern, 2) Healthy Mediterranean-Style Eating Pattern, and 3) Healthy Vegetarian Eating Pattern.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| US Healthy Diet | Experimental | Behavioral: Dietary Intervention ClassesParticipants in this group will be assigned to follow the Healthy US dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern is based on the types and amounts of foods Americans typically consume. The main types of food in this eating pattern include a variety of vegetables; fruits; whole grains; fat-free or low-fat dairy; seafood, poultry, meat, and eggs; and nuts, seeds, and soy products. |
| Mediterranean diet | Experimental | Behavioral: Dietary Intervention ClassesParticipants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern. |
| Vegetarian diet | Experimental | Behavioral: Dietary Intervention ClassesParticipants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. As described here https://www.nia.nih.gov/health/usda-food-patterns: This eating pattern contains no meat, poultry, or seafood. Compared with the Healthy U.S.-Style Eating Pattern, it contains more soy products, eggs, beans and peas, nuts and seeds, and whole grains. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Intervention ClassesParticipants will attend classes once per week for 6 months and then bi-weekly for 6 months. | Behavioural | Mediterranean diet, US Healthy Diet, Vegetarian diet |
Primary outcome
Changes in dietary quality
Time frame: 12 months
Changes in dietary quality as assessed by the Healthy Eating Index
Changes in body weight
Time frame: 12 months
Changes in body weight
Changes in HgbA1c
Time frame: 12 months
Changes in HgbA1c
1 secondary outcome
Changes in blood pressure
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 41077220Bailey S, Turner-McGrievy GM, Keseko EA, Duncan T, Ward-Johnson D, Davis B, Wilcox S, Friedman DB, Sarzynski MA, Liese AD. The Diet Guidelines: 3 Diets (DG3D) study protocol of a behavioral teaching kitchen intervention for type-2 diabetes prevention among African American adults. Contemp Clin Trials. 2025 Dec;159:108109. doi: 10.1016/j.cct.2025.108109. Epub 2025 Oct 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention Classes in people with Diabetes Mellitus, Type 2 and Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in dietary quality (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.