The Nutritious Eating with Soul (NEW Soul) Study: Study design and methods of a two-year randomized trial comparing culturally adapted soul food vegan vs. omnivorous diets among African American adults at risk for heart disease

Abstract Background Previous research has found that African American (AA) vegetarians/vegans have a significantly lower body mass index and risk of hypertension compared to omnivores. Objectives The Nutritious Eating with Soul (NEW Soul) study partnered with local soul food restaurants/chefs to deliver two behavioral nutrition interventions to AA adults. NEW Soul examines the impact of two different culturally tailored diets (vegan and omnivorous low-fat) on changes in risk factors for cardiovascular disease (CVD). Methods AA adults with overweight or obesity are recruited from the community in the Midlands of South Carolina. Eligible participants are randomized to follow one of two different culturally-adapted, soul food diets: a vegan diet emphasizing minimally-processed whole foods from plants or a low-fat omnivorous diet. Participants attend weekly group classes for the first six months, bi-weekly for the next six months, and monthly meetings for the last year. In addition to face-to-face content, participants also have access to private Facebook groups for their diet, podcasts, and online newsletters starting at six months. Primary outcomes include changes in body weight and CVD risk factors (lipids, blood pressure, glucose, and insulin) at 12 months. Secondary outcomes include changes in dietary intake. Participants complete assessments at baseline and at months 6, 12, and 24. Conclusions The NEW Soul study is an innovative intervention aimed at improving dietary intake while maintaining traditional AA cultural food choices. Primary outcomes are expected by 2021.