Expanding the reach of the Nutritious Eating with Soul (NEW Soul) program: A Type 2 hybrid effectiveness-implementation trial

项目概要/摘要 非裔美国人（AAs）不成比例地受到心血管疾病（CVD）和肥胖的影响。AA 与AA杂食者相比，素食者/纯素食者患高血压和糖尿病的风险显著降低。 素食灵魂食品餐厅已成为一个潜在的社区合作伙伴，为顾客介绍健康的 熟悉的灵魂美食的版本。探索这种干预对AA的潜在影响， 超重或肥胖的人还没有遵循纯素饮食，我们进行了营养饮食， 在南卡罗来纳州哥伦比亚的大学环境中进行的灵魂干预（NEW Soul; R 01 HL 135220）（n=159例AA; 素食与低脂杂食性饮食，两者都专注于灵魂食物）。我们完成了3个月的评估， 保持率（88%）和显著的体重减轻（素食者-2.2至2.8千克;杂食者-1.2至2.7千克; p=0.03）。 我们建议研究遥距发放为期3个月的新灵计划的成效及推行情况 程序.我们将与两家素食灵魂食品餐厅合作（见支持信）。我们有以下 目的： 目标1：评估为期3个月的新灵魂餐厅交付计划在两个重要方面的效果 超重或肥胖的AA中CVD发展的因素（体重和饮食质量）。 参与者（n=228）将被随机分配到以下两种情况之一：1.远程交付的每周实时课程 2.餐厅优惠券（干预）或2.仅餐厅代金券（主动控制）。 目标2：对提供在线干预加凭单与凭单进行成本效益分析- 仅与体重、HEI和质量调整生命年（QALY）的成本/变化结果相关。这包括 估计干预本身的成本（例如，培训、交付、基础设施）。 目标3a：检查新灵魂研究的实施情况。以执行成果为指导 普罗克特等人的框架。例如，和Waltz，et.例如，我们会研究 新灵魂实施策略的可行性和实用性（例如，提供反复的帮助， 持续的培训和咨询，集中技术援助）。我们会委聘 定性（与干预工作人员和参与者焦点小组的半结构化访谈），以及 定量（对参与者的调查）研究方法，将由CFIR领域（干预）指导 特征、内部设置、外部设置、个体特征和过程）。 目标3b：在目标1-3a的调查结果的基础上，我们将进行干预和 餐厅工作人员，以确定领域，以准备干预广泛采用素食灵魂食品 东南部的餐馆。我们将专注于设计质量和包装，CFIR的一部分 “干预特征”域。

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.