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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. There is also less calcium and vitamin D because it includes fewer dairy foods. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention Meetings | Behavioral | Participants will attend classes once per week for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delta Dietary Quality | 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). | From baseline to the end of the intervention at 3 months |
| Delta Body Weight | Change in body weight from baseline to the end of the intervention at 3 months | From baseline to the end of the intervention at 3 months |
| Delta Hemoglobin A1c | Change in HgbA1c from baseline to the end of the intervention at 3 months | From baseline to the end of the intervention at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Delta Systolic Blood Pressure | Change in systolic blood pressure from baseline to the end of the intervention at 3 months | From baseline to the end of the intervention at 3 months |
| Delta Diastolic Blood Pressure |
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Inclusion Criteria:
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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39366028 | Derived | Turner-McGrievy G, Wirth MD, Okpara N, Jones M, Kim Y, Wilcox S, Friedman DB, Sarzynski MA, Liese AD. Similar changes in diet quality indices, but not nutrients, among African American participants randomized to follow one of the three dietary patterns of the US Dietary Guidelines: A secondary analysis. Nutr Res. 2024 Nov;131:27-38. doi: 10.1016/j.nutres.2024.09.005. Epub 2024 Sep 7. | |
| 36894249 |
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To be determined
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Eligible and interested participants were offered a choice of orientation session times. During the session, the study coordinator provided a comprehensive overview of the study, addressed participant questions, and obtained informed consent. Those who successfully completed baseline procedures were subsequently randomized.
The DG3D Aim 1 study was a 12-week, 3-arm randomized dietary intervention. Recruitment was implemented through news, media, and online/social media advertisements, electronic mailing lists, community outreach events, and flyers. Recruitment occurred from July - September 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy U.S.-Style Eating Pattern | Participants in this group will be assigned to follow the Healthy US dietary pattern as presented by the US Dietary Guidelines. 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. |
| FG001 | Healthy Mediterranean-Style Eating Pattern | Participants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern. There is also less calcium and vitamin D because it includes fewer dairy foods. |
| FG002 | Healthy Vegetarian Eating Pattern | Participants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy U.S.-Style Eating Pattern | Participants in this group will be assigned to follow the Healthy US dietary pattern as presented by the US Dietary Guidelines. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participant's age at baseline assessment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delta Dietary Quality | 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). | Posted | Mean | Standard Error | Scores on a scale | From baseline to the end of the intervention at 3 months |
|
Up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | US Healthy Diet | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brie Turner-McGrievy | University of South Carolina | 803-777-3932 | brie@sc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2026 | Feb 19, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 30, 2020 | Feb 19, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Assessors will be blinded to participant group.
Change in diastolic blood pressure from baseline to the end of the intervention at 3 months
| From baseline to the end of the intervention at 3 months |
| Derived |
| Turner-McGrievy GM, Wilson MJ, Carswell J, Okpara N, Aydin H, Bailey S, Davey M, Hutto B, Wilcox S, Friedman DB, Sarzynski MA, Liese AD. A 12-Week Randomized Intervention Comparing the Healthy US, Mediterranean, and Vegetarian Dietary Patterns of the US Dietary Guidelines for Changes in Body Weight, Hemoglobin A1c, Blood Pressure, and Dietary Quality among African American Adults. J Nutr. 2023 Feb;153(2):579-587. doi: 10.1016/j.tjnut.2022.11.020. Epub 2022 Dec 23. |
| BG001 | Healthy Mediterranean-Style Eating Pattern | Participants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern. There is also less calcium and vitamin D because it includes fewer dairy foods. |
| BG002 | Healthy Vegetarian Eating Pattern | Participants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| y |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Occupation | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Body weight | Body weight was in light street clothing using a calibrated digital scale model 500 KL (Health-o-Meter) | Mean | Standard Deviation | kg |
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| HbA1c | Whole blood was collected via finger stick and the DCA Vantage Analyzer was used for analysis. | Mean | Standard Deviation | % |
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| Systolic Blood Pressure | Blood pressure was assessed after a 5-minute rest period using an Omron Hem 705 CP Auto Inflate BP Monitor. At least 2 readings were taken with the mean of those readings being used. If there was a >5 mm Hg difference between the first and second readings, subsequent readings (up to 4) were taken. | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Blood pressure was assessed after a 5-minute rest period using an Omron Hem 705 CP Auto Inflate BP Monitor. At least 2 readings were taken with the mean of those readings being used. If there was a >5 mm Hg difference between the first and second readings, subsequent readings (up to 4) were taken. | Mean | Standard Deviation | mmHg |
|
| Healthy Eating Index (HEI) Score | The Healthy Eating Index (HEI) total score ranges from 0 to 100, with 0 indicating minimal adherence to the Dietary Guidelines for Americans and 100 indicating perfect adherence and optimal diet quality. Higher scores indicate better diet quality. Participants completed three unannounced 24-hour dietary recalls at each time point using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Recall (ASA24), including one weekend day and two weekdays. The three recalls were averaged and used to calculate HEI total scores. | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Healthy Mediterranean-Style Eating Pattern | Participants in this group will be assigned to follow the Mediterranean dietary pattern as presented by the US Dietary Guidelines. This eating pattern contains more fruits and seafood and less dairy than the Healthy U.S.-Style Eating Pattern. There is also less calcium and vitamin D because it includes fewer dairy foods. |
| OG002 | Healthy Vegetarian Eating Pattern | Participants in this group will be assigned to follow the Vegetarian dietary pattern as presented by the US Dietary Guidelines. 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. |
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| Primary | Delta Body Weight | Change in body weight from baseline to the end of the intervention at 3 months | Posted | Mean | Standard Error | kg | From baseline to the end of the intervention at 3 months |
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| Primary | Delta Hemoglobin A1c | Change in HgbA1c from baseline to the end of the intervention at 3 months | Posted | Mean | Standard Error | HbA1c % | From baseline to the end of the intervention at 3 months |
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| Secondary | Delta Systolic Blood Pressure | Change in systolic blood pressure from baseline to the end of the intervention at 3 months | Posted | Mean | Standard Error | mm Hg | From baseline to the end of the intervention at 3 months |
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| Secondary | Delta Diastolic Blood Pressure | Change in diastolic blood pressure from baseline to the end of the intervention at 3 months | Posted | Mean | Standard Error | mm Hg | From baseline to the end of the intervention at 3 months |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Mediterranean Diet | 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. There is also less calcium and vitamin D because it includes fewer dairy foods. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Vegetarian Diet | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D004700 | Endocrine System Diseases |