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: 10608133
• 负责人: Gabrielle Michelle Turner-McGrievy
• 金额: $ 72.25万
• 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/10608133
• 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; Fatty acid glycerol esters; Focus Groups; Food; Funding; Goals; Hypertension; Individual; Infrastructure; Intervention; Intervention Studies; Interview; 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 trial; implementation intervention; implementation outcomes; implementation strategy; improved; informant; intervention cost; intervention program; 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(AA)受心血管疾病(CVD)和肥胖的影响不成比例。AA 与AA杂食者相比，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经成为一个潜在的社区合作伙伴，向顾客介绍健康 熟悉的灵魂食物菜肴的版本。探讨这一干预措施对美国儿科协会的潜在影响 超重或肥胖的人没有遵循素食饮食，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提供(n=159名AA； 纯素食与低脂杂食性饮食，两者都侧重于灵魂食物)。我们以高分完成了为期3个月的评估 保留率(88%)和显著的体重减轻(素食-2.2±2.8公斤；杂食性-1.2±2.7公斤；p=0.03)。 我们建议检查远程交付、为期3个月的新灵魂的有效性和实施情况 程序。我们将与两家素食灵魂食品餐厅合作(见支持信)。我们有以下几个方面 目标： 目标1：评估为期3个月的新Soul餐厅交付计划在两个重要项目上的效果 超重或肥胖者心血管疾病发生的因素(体重和饮食质量)。 参与者(n=228)将被随机分为两种情况之一：1.远程直播每周课程 有餐厅代金券(干预)或2.仅有餐厅代金券(主动控制)。 目标2：进行在线干预+代金券与代金券交付的成本效益分析- 仅考虑体重、HEI和质量调整寿命年(QALY)的成本/变化结果。这包括 估计干预措施本身的成本(例如，培训、交付、基础设施)。 目标3a：检查新的Soul研究的实施情况。以实施成果为指导 Proctor等人的框架。以及Waltz等人描述的实现策略。Al.，我们将研究 新的Soul实施战略的可行性和实用性(例如，提供迭代援助、提供 正在进行的培训和咨询、集中技术援助)。我们将聘用 定性(与干预工作人员和有参与者的焦点小组进行半结构化访谈)，以及 量化(与参与者一起调查)研究方法，将以CFIR领域(干预)为指导 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，我们将进行关键线人访谈，并进行干预和 餐厅工作人员确定区域，为素食灵魂食品的广泛采用做好干预准备 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。