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

扩大灵魂营养饮食 (NEW Soul) 计划的范围：2 类混合有效性实施试验

• 批准号: 10430659
• 负责人: Gabrielle Michelle Turner-McGrievy
• 金额: $ 72.74万
• 依托单位: UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-15 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10430659
• 关键词: Adopted; Adoption; Affect; African American; African American population; Area; Behavior Therapy; Body Weight; Body Weight decreased; Cardiovascular Diseases; Characteristics; Communities; Consultations; Cost Effectiveness Analysis; Development; Diabetes Mellitus; Diet; Eating; Effectiveness; Fatty acid glycerol esters; Focus Groups; Food; Funding; Goals; Hypertension; Individual; Infrastructure; Intervention; Interview; Lead; Letters; National Heart, Lung, and Blood Institute; Nutritional; Obesity; Outcome; Overweight; Participant; Process; Proctor framework; Quality-Adjusted Life Years; Randomized; Research Methodology; Restaurants; Risk; Structure; Surveys; Testing; Training; Universities; Vegan Diet; Weight; Work; active control; cost estimate; cost outcomes; design; dietary; effectiveness evaluation; effectiveness implementation study; effectiveness implementation trial; implementation outcomes; implementation strategy; informant; intervention cost; online delivery; online intervention; programs; remote delivery; retention rate; scale up; staff intervention; voucher

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.

项目摘要/摘要 非裔美国人（AAS）受心血管疾病（CVD）和肥胖症的影响不成比例。 aa 与AA杂食动物相比，蔬菜/素食主义者的高血压和糖尿病风险明显降低。 素食主义者灵魂餐厅已成为向顾客介绍健康的潜在社区合作伙伴 熟悉的灵魂食品烹饪的版本。探索这种干预对AAS的潜在影响 尚未遵循素食饮食的超重或肥胖症，我们与 灵魂干预（新灵魂； R01HL135220），在南卡罗来纳州哥伦比亚的一所大学环境中（n = 159 AAS； 素食主义者与低脂杂食性饮食，都专注于灵魂食品）。我们完成了3个月的评估 保留率（88％）和显着的体重减轻（素食-2.2±2.8 kgs;杂食-1.2±2.7 kgs; p = 0.03）。 我们建议研究一个遥远的，三个月的新灵魂的有效性和实施 程序。我们将与两家纯素食灵魂餐厅合作（请参阅支持信）。我们有以下 目标： 目的1：评估两个重要的两个重要的新灵魂餐厅提供计划的有效性 具有超重或肥胖症的AA中CVD（体重和饮食质量）发展的因素。 参与者（n = 228）将被随机分为两个条件之一：1。 带有餐厅凭证（干预）或2。餐厅凭证（主动控制）。 AIM 2：进行成本效益分析，以交付在线干预以及代金券 - 仅在体重成本/变化的结果中，HEI和质量调整后的生活年度（QALY）。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。在实施结果的指导下 Proctor等人的框架。 Al。以及华尔兹等描述的实施策略。 Al。，我们将检查 新灵魂实施策略的可行性和效用（例如，提供迭代帮助，提供 正在进行的培训和咨询，集中技术援助）在餐厅环境中。我们将雇用 定性（与干预人员和焦点小组的半结构化访谈），以及 定量（与参与者的调查）研究方法，该方法将由CFIR领域（干预）指导 特征，内部设置，外部设置，个人特征和过程）。 AIM 3B：基于AIMS 1-3A的发现，我们将通过干预和 餐厅工作人员确定准备干预措施的区域，以通过素食灵魂食品采用宽度 东南部的餐馆。我们将专注于设计质量和包装，这是CFIR的一部分 “干预特征”领域。