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Nutritious Eating With Soul (The NEW Soul Study)

University of South Carolina · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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naoverweight-and-obesity
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: 1. Risk factors for CVD, including LDL cholesterol and blood pressure; and 2. Body weight. Secondary Aim 3. Examine long-term changes in CVD risk factors and body weight at 24 months.
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