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.

项目概要/摘要 非裔美国人 (AA) 受心血管疾病 (CVD) 和肥胖的影响尤为严重。 AA 与 AA 杂食者相比，素食者/严格素食者患高血压和糖尿病的风险显着降低。 素食灵魂食品餐厅已成为向顾客介绍健康食品的潜在社区合作伙伴 熟悉的灵魂美食的版本。探讨这种干预措施对 AA 的潜在影响 对于尚未遵循纯素饮食的超重或肥胖者，我们进行了营养饮食 灵魂干预（NEW Soul；R01HL135220），在南卡罗来纳州哥伦比亚的一所大学环境中进行（n=159 AA； 纯素食与低脂杂食饮食，两者都侧重于灵魂食物）。我们完成了为期 3 个月的评估，成绩优异 保留率（88%）和显着的体重减轻（素食-2.2±2.8公斤；杂食-1.2±2.7公斤；p=0.03）。 我们建议检查远程交付的 3 个月 NEW Soul 的有效性和实施情况 程序。我们将与两家纯素食灵魂食品餐厅合作（请参阅支持信）。我们有以下 目标： 目标 1：评估为期 3 个月的 NEW Soul 餐厅实施计划在两个重要方面的有效性 超重或肥胖 AA 中发生 CVD（体重和饮食质量）的因素。 参与者 (n=228) 将被随机分配到以下两个条件之一： 1. 每周远程直播课程 使用餐厅优惠券（干预）或 2. 仅使用餐厅优惠券（主动控制）。 目标 2：对提供在线干预加代金券与代金券进行成本效益分析 仅考虑体重、HEI 和质量调整生命年 (QALY) 的成本/变化结果。这包括 估算干预措施本身的成本（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。以实施成果为导向 Proctor 等人的框架等人，以及 Waltz 等人描述的实施策略。等，我们将检查 NEW Soul 实施策略的可行性和实用性（例如，提供迭代协助、提供 在餐厅环境中进行持续的培训和咨询，集中技术援助）。我们将聘用 定性（与干预人员进行半结构化访谈以及与参与者进行焦点小组访谈），以及 定量（参与者调查）研究方法，将由 CFIR 领域（干预 特征、内部环境、外部环境、个人特征和过程）。 目标 3b：根据目标 1-3a 的调查结果，我们将对关键知情人进行干预和访谈 餐厅工作人员确定准备干预措施的领域，以供纯素灵魂食品广泛采用 东南部各地的餐馆。我们将重点关注设计质量和包装，这是 CFIR 的一部分 “干预特征”域。