Expanding the reach of the Nutritious Eating with Soul (NEW Soul) program: A Type 2 hybrid effectiveness-implementation trial - Project Summary/Abstract African Americans (AAs) are disproportionately affected by cardiovascular disease (CVD) and obesity. AA vegetarians/vegans have significantly lower risks of hypertension and diabetes as compared to AA omnivores. Vegan soul food restaurants have emerged as a potential community partner for introducing patrons to healthy versions of familiar soul food cuisine. To explore the potential impact of this intervention on AAs with overweight or obesity who were not already following vegan diets, we conducted the Nutritious Eating with Soul intervention (NEW Soul; R01HL135220), delivered in a university setting in Columbia, SC (n=159 AAs; vegan vs. low-fat omnivorous diet, both focused on soul food). We completed 3-month assessments with high retention rates (88%) and significant weight loss (vegan -2.2±2.8 kgs; omnivorous -1.2±2.7 kgs; p=0.03). We propose to examine the effectiveness and implementation of a remotely-delivered, 3-month NEW Soul program. We will work with two vegan soul food restaurants (see letters of support). We have the following aims: Aim 1: Evaluate the effectiveness of the 3-month NEW Soul restaurant-delivered program on two important factors in the development of CVD (body weight and diet quality) among AAs with overweight or obesity. Participants (n=228) will be randomized to one of two conditions: 1. Remotely delivered live weekly classes with restaurant vouchers (intervention) or 2. restaurant voucher-only (active control). Aim 2: Conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher- only with the outcome of cost/change in weight, HEI and quality adjusted life year (QALY). This includes estimating costs of the intervention itself (e.g., training, delivery, infrastructure). Aim 3a: Examine the implementation of the NEW Soul study. Guided by the implementation outcome framework by Proctor, et. al., and the implementation strategies described by Waltz, et. al., we will examine the feasibility and utility of the NEW Soul implementation strategies (e.g., provide iterative assistance, provide ongoing training and consultation, centralize technical assistance) in restaurant settings. We will employ qualitative (semi-structured interviews with intervention staff and focus groups with participants), and quantitative (surveys with participants) research methods, which will be guided by CFIR domains (intervention characteristics, inner setting, outer setting, characteristics of individuals, and process). Aim 3b: Building on the findings from Aims 1-3a, we will conduct key informant interviews with intervention and restaurant staff to identify areas to prepare the intervention for widespread adoption by vegan soul food restaurants across the southeast. We will focus on the design quality and packaging, part of the CFIR “intervention characteristics” domain.
