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This study addresses two challenges seen among African American (AA) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (CVD) risk: poor weight loss results and high attrition rates. Investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for AA adults living in the South. Therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects CVD risk factors and weight as compared with an omni diet. The study will randomize overweight AA adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. Investigators will accomplish objectives and test hypotheses by following two specific primary aims:
Primary Aims: Using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in:
Risk factors for CVD, including LDL cholesterol and blood pressure; and
Body weight.
Secondary Aim
Examine long-term changes in CVD risk factors and body weight at 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vegan Diet | Experimental | Participants in this group will follow a plant-based vegan diet. The vegan group diet will be based on investigators' pilot work, which instructs participants to favor a diet built around whole grains, fruits, vegetables, and legumes. This group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide. A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course. Interventions include intervention meetings, physical activity, and podcasts/mailings. |
|
| Omnivorous (Omni) Diet | Experimental | Participants in this group will follow a low-fat omni diet. The diet intervention for the omni group will be supplemented by the Oldways African Heritage and Health program, which includes a food pyramid guide, A Taste of African Heritage (ATAH) six-lesson nutrition and cooking program and an online course for health professionals and cooking instructors (all research and restaurant team members will complete this course). Interventions include intervention meetings, physical activity, and podcasts/mailings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention Meetings | Behavioral | Participants will attend classes once per week for the first 6 months, bi-weekly for the next 6 months; then once a month for the last 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Disease Prevention based on dietary approach. | Which dietary approach (vegan or omni) best targets both cardiovascular disease prevention and weight loss among overweight African Americans. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brie Turner-McGrievy, PhD, MS, RD | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Discovery | Columbia | South Carolina | 29208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41970465 | Derived | Bell A, Bernhart JA, Kim Y, Keseko EA, Turner-McGrievy G. The Association Between Power of Food Scale Scores and Weight Among Black/African American Individuals Consuming a Vegan or Low-Fat Omnivorous Diet in a Randomized Controlled Trial. J Nutr Metab. 2026 Apr 9;2026:4084525. doi: 10.1155/jnme/4084525. eCollection 2026. | |
| 39345782 |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Physical Activity | Behavioral | Participants will be given the following exercise recommendations: strength training twice per week and ≥75 min of vigorous or ≥150 min of moderate PA per week and will be provided with accelerometers. |
|
| Podcasts/Mailings | Behavioral | Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters. |
|
| Turner-McGrievy GM, Wilcox S, Frongillo EA, Murphy EA, Kim Y, Hu EA, Okpara N, Bailey S. Impact of diet adherence on weight and lipids among African American participants randomized to vegan or omnivorous diets. Obes Sci Pract. 2024 Sep 27;10(5):e70009. doi: 10.1002/osp4.70009. eCollection 2024 Oct. |
| 38373534 | Derived | Turner-McGrievy GM, Wilcox S, Frongillo EA, Kim Y, Okpara N, Wilson M. Differences in dietary acceptability, restraint, disinhibition, and hunger among African American participants randomized to either a vegan or omnivorous soul food diet. Appetite. 2024 May 1;196:107280. doi: 10.1016/j.appet.2024.107280. Epub 2024 Feb 17. |
| 37437808 | Derived | Bernhart JA, Quattlebaum M, Eustis S, Okpara N, Wilson MJ, Sentman C, Turner-McGrievy GM. "It's Gonna Be Okay"-A Qualitative Exploration of the COVID-19 Pandemic's Effects on African American Participants During a Dietary Intervention Study. J Acad Nutr Diet. 2023 Dec;123(12):1763-1771. doi: 10.1016/j.jand.2023.07.003. Epub 2023 Jul 16. |
| 36633848 | Derived | Turner-McGrievy GM, Wilcox S, Frongillo EA, Murphy EA, Hutto B, Wilson M, Davey M, Bernhart JA, Okpara N, Bailey S, Hu E. Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African American Adults: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250626. doi: 10.1001/jamanetworkopen.2022.50626. |
| 36469289 | Derived | Bernhart JA, Fellers AW, Wilson MJ, Hutto B, Bailey S, Turner-McGrievy GM. COVID-19 Pandemic Associations on Mental and Physical Health in African Americans Participating in a Behavioral Intervention. J Racial Ethn Health Disparities. 2023 Dec;10(6):3070-3076. doi: 10.1007/s40615-022-01481-6. Epub 2022 Dec 5. |
| 32827219 | Derived | Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 Aug 21;8(8):CD011737. doi: 10.1002/14651858.CD011737.pub3. |
| 32428300 | Derived | Hooper L, Martin N, Jimoh OF, Kirk C, Foster E, Abdelhamid AS. Reduction in saturated fat intake for cardiovascular disease. Cochrane Database Syst Rev. 2020 May 19;5(5):CD011737. doi: 10.1002/14651858.CD011737.pub2. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |