The ADELANTE Trial: Testing a multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes

项目摘要 拉丁美洲人占SARS-CoV-2（COVID-19）病例（60%）和死亡人数（48%）的最大份额， 加州的任何其他种族/民族。此外，拉丁美洲家庭经历了戏剧性的 由于这一流行病，家庭粮食不安全状况加剧。这对患有2型糖尿病的拉丁裔人来说尤其令人痛心 糖尿病（T2DM）作为家庭粮食不安全与血糖控制较差有关，这具有生命- 在COVID-19大流行期间的威胁后果。2型糖尿病，尤其是控制不佳的2型糖尿病，是一种 COVID-19死亡的风险因素。采取有效的多层次干预措施，改善家庭粮食不安全状况， 糖尿病患者迫切需要血糖控制，以减轻COVID-19造成的差异。的 ADELANTE（通过提高营养获取来解决糖尿病：有效性试验）的目标是 以确定是否有多层次的干预措施，以改善家庭粮食不安全和血糖 控制对拉丁裔糖尿病患者有效。我们将使用1型杂交试验来评估 多水平干预对6个月时血糖控制（HbA1c）主要结局的有效性。 参与者（n = 355）将被随机分配到：1）12周的富含纤维食物的家庭分娩 （蔬菜，豆类/豆类和全谷物）加上12个月的远程交付，适应文化的生活方式 行为干预称为维达萨那，或2）候补对照组，接受干预后，6个月 延迟我们将对参与者进行12个月的随访，以评估6个月时HbA1c的主要结局以及 关键次要结局，如12个月时的HbA1c，以及6个月和12个月时的糖尿病和COVID相关压力 个月此外，我们将为每位参与者招募最多2名家庭成员， 次要结果，如家庭粮食不安全，饮食行为和COVID相关压力。到 评估在初级保健中实施和传播多层次干预措施的未来潜力 我们将使用混合方法，包括定量测量（例如，干预剂量和保真度）和定性 与参与者和关键利益攸关方的访谈（例如，供应商，诊所领导，社区支持 根据RE-AIM（Reach，Effectiveness，Adoption，Implementation， 维护）框架。我们将让患者和我们的长期社区合作伙伴参与到所有阶段， 庭审审判将在加州的阿拉米达县进行，该县是一个庞大而多样化的拉丁裔的家园 La Clínica de La Raza是一个社区安全网诊所，在整个阿拉米达有多个地点， 县这些目标的成功实现将有力地证明提高妇女地位的有效性。 家庭粮食不安全和糖尿病流行期间拉丁美洲人的血糖控制。

PROJECT SUMMARY Latinos account for the largest share of SARS-CoV-2 (COVID-19) cases (60%) and deaths (48%) compared to any other racial/ethnic group in California. Additionally, Latino households have experienced a dramatic increase in household food insecurity due to the pandemic. This is especially distressing for Latinos with type 2 diabetes (T2DM) as household food insecurity is associated with worse glycemic control, which has life- threatening consequences during the COVID-19 pandemic. T2DM, and especially poorly controlled T2DM, is a risk factor for death from COVID-19. Effective multilevel interventions to improve household food insecurity and glycemic control are urgently needed for Latinos with diabetes to mitigate disparities due to COVID-19. The goal of ADELANTE (Addressing Diabetes by ELevating Access to Nutrition: A Trial of Effectiveness) is to determine whether a multi-level intervention to improve household food insecurity and glycemic control is effective for Latino patients with diabetes. We will use a type 1 hybrid trial to assess the effectiveness of the multilevel intervention on the primary outcome of glycemic control (HbA1c) at 6 months. Participants (n=355) will be randomized to either: 1) 12 weeks of household deliveries of fiber-rich foods (vegetables, beans/legumes, and whole grains) plus a 12-month remotely delivered, culturally-adapted lifestyle behavioral intervention called Vida Sana, or 2) a waitlist control arm, receiving the intervention after a 6-month delay. We will follow participants for 12 months to assess the primary outcome ofHbA1c at 6 months as well as key secondary outcomes such as HbA1c at 12 months, and diabetes- and COVID-related stress at 6 and 12 months. Additionally, we will recruit up to 2 household members for each participant to assess household-level secondary outcomes such as household food insecurity, dietary behaviors, and COVID-related stress. To assess the future potential of implementation and dissemination of the multilevel intervention in primary care we will use mixed methods including quantitative measures (e.g., intervention dose and fidelity) and qualitative interviews with participants and key stakeholders (e.g., providers, clinic leadership, community supported agricultural group) according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. We will involve patients and our longstanding community partners in all phases of the trial. The trial will take place in Alameda County, California, which is home to a large and diverse Latino population, at La Clínica de La Raza, a community safety net clinic with multiple locations throughout Alameda County. Successful completion of these aims will provide robust evidence of the effectiveness of improving household food insecurity and glycemic control among Latinos with diabetes during the pandemic.