Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African American Adults: A Randomized Clinical Trial.

Importance: More African American individuals die from cardiovascular disease (CVD) than any other chronic disease condition. Despite this disparity, African American individuals are underrepresented in nutrition and CVD interventions. Objective: To compare the effects of an entirely plant-based (vegan) or low-fat omnivorous (omni) diet on change in body weight and lipids during a 2-year intervention. Design, Setting, and Participants: The Nutritious Eating With Soul (NEW Soul) study was a 2-year, randomized clinical trial conducted in 2 cohorts (2018-2020 and 2019-2021) that took place in a university teaching kitchen in Columbia, South Carolina (before March 2020), and via online videoconference sessions (after March 2020). Participants included African American adults aged 18 to 65 years with overweight or obesity (body mass index of 25.0-49.9) and without type 2 diabetes, uncontrolled thyroid disease, recent weight loss, or pregnancy. Data assessors and statisticians were blinded to study condition. Data analysis was performed from March to June 2022. Interventions: The intervention included weekly nutrition classes for 6 months biweekly classes for 6 months, and monthly classes for 12 months. Dietary interventions either emphasized no animal product intake (vegan) or a low-fat omnivorous diet (omni). Both dietary patterns emphasized soul food cuisine (traditional African American southern foodways). Main Outcomes and Measures: Primary outcomes included change in body weight and lipid measures at 12 months. Results: There were 568 participants who completed an online screening questionnaire; 409 were excluded and 159 were randomized (77 to the vegan group and 82 to the omni group). Of the 159 participants (mean [SD] age, 48.4 [10.6] years; 126 female [79%]) who began the study, the main outcome of body weight was obtained for 121 participants (76%) at 12 months. There were no differences in outcomes between groups, including 12-month changes in weight (mean, -2.39 kg [95% CI, -3.48 to -1.30 kg] for the vegan group vs -2.03 kg [95% CI, -3.07 to -1.00 kg] for the omni group; P = .64), total cholesterol (-1.05 mg/dL [95% CI, -9.60 to 7.50 mg/dL] for the vegan group vs 1.66 mg/dL [95% CI, -7.20 to 10.50 mg/dL] for the omni group; P = .67), or low-density lipoprotein cholesterol (mean, -2.56 mg/dL [95% CI, -9.52 to 4.40 mg/dL] for the vegan group vs -0.79 mg/dL [95% CI, -7.98 to 6.40 mg/dL] for the omni group; P = .73). Weight loss at 12 months among cohort 1, whose weight was assessed in 2019 before the COVID-19 pandemic, was significantly greater than that for cohort 2, whose weight was assessed summer 2020 during COVID-19 (-3.45 kg [95% CI, -4.67 to -2.22 kg] vs -1.24 kg [95% CI, -2.24 to -0.25 kg]; P = .01). Conclusions and Relevance: In this randomized clinical trial examining weight loss and CVD risk factor reduction among African American adults, there were no differences between the groups, and the magnitude of changes overall was small. Trial Registration: ClinicalTrials.gov Identifier: NCT03354377.

NEW Soul in the neighborhood-reach and effectiveness of a dissemination and implementation feasibility study.

Dissemination and implementation (D&I) studies of dietary interventions for African Americans are limited. Restaurants may be an innovative setting to deliver dietary interventions. Purpose: Assess weight loss, self-efficacy for healthy eating, diet quality, and quality of life in African Americans in two groups: virtual synchronous and virtual asynchronous. Guided by RE-AIM, the Nutritious Eating with Soul @ Rare Variety Café Feasibility study included nutrition education, accountability partners for support, and cooking demonstrations led by a community health worker and was delivered across two cohorts in a non-randomized design. The intervention was conducted over 12 consecutive weekly classes. Due to the COVID-19 pandemic, intervention delivery was online. African Americans between 18-65 years old with overweight/obesity, not currently following a plant-based diet or taking medications to control diabetes, and living in a southeastern city were recruited. Participants completed in-person weight assessments and online surveys at baseline and post-intervention. Linear mixed models analyzed changes in outcomes and differences in 3-month outcomes between groups. All models controlled for age and sex. Regarding Reach, 199 participants expressed interest, and 60 enrolled. Among the full sample, participants decreased body weight -2.6 ± 0.5 kg (p < .0001) and increased self-efficacy 1.6 ± 0.7 points (p = .03). No differences in 3-month outcomes between groups were observed. This D&I feasibility study successfully recruited participants during the COVID-19 pandemic and produced significant results. The successful online intervention delivery compared to in-person suggests the potential for greater D&I in vegan soul food restaurants. As restrictions are loosened, future studies will test in-person delivery.

Guided by RE-AIM, the Nutritious Eating with Soul @ Rare Variety Feasibility Trial (NEW Soul @ RV) assessed Reach and Effectiveness outcomes in participants in a soul food, plant-based dissemination and implementation study. The research team successfully partnered with a local restaurant to host and deliver the intervention. Due to the COVID-19 pandemic, the intervention was delivered using two intervention groups: virtual synchronous and virtual asynchronous. The dissemination and implementation feasibility study successfully recruited African American participants leading to a meaningful primary outcome in weight loss as well as improvements in a secondary outcome of diet self-efficacy. Findings emphasize the potential for greater dissemination and implementation of NEW Soul @ RV throughout African American vegan soul food restaurants.