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

ADELANTE 试验：测试一种多层次方法，以改善拉丁裔糖尿病患者的家庭粮食不安全和血糖控制

• 批准号: 10621914
• 负责人: Lisa Goldman Rosas
• 金额: $ 60.23万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-04 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10621914
• 关键词: 2019-nCoV; Address; Adolescent; Adopted; Adult; Agriculture; Behavior; Behavior Therapy; COVID-19; COVID-19 complications; COVID-19 disparity; COVID-19 mortality; COVID-19 pandemic; California; Calories; Cessation of life; Classification; Clinic; Communities; Control Groups; Coping Skills; County; Diabetes Mellitus; Diet; Dietary Fiber; Dissemination and Implementation; Distress; Dose; Effectiveness; Effectiveness of Interventions; Ethnic Population; Fabaceae; Family member; Farm; Fiber; Food; Future; Gender; Glycosylated hemoglobin A; Goals; Government; Government Programs; Health Food; Home; Household; Immigration; Individual; Intake; Intervention; Interview; Latino; Latino Population; Leadership; Life; Life Style; Location; Loneliness; Measures; Mediator; Methods; Neighborhood Health Center; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Overweight; Participant; Patients; Persons; Phase; Primary Care; Provider; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Recurrence; Risk Factors; Rotation; Seasons; Social Distance; Social support; Stress; Testing; Time; United States; Vegetables; Waiting Lists; arm; bean; coronavirus disease; cost; depressive symptoms; design; diabetes control; dietary; disparity reduction; effectiveness evaluation; effectiveness trial; experience; food insecurity; glycemic control; good diet; high risk; hybrid type 1 trial; improved; lifestyle intervention; member; neighborhood safety; nutrition; pandemic disease; preservation; primary outcome; programs; psychosocial; racial population; recruit; remote delivery; safety net; screening; secondary outcome; social; treatment as usual

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.

项目总结 与#年相比，拉美裔人在SARS-CoV-2(新冠肺炎)病例(60%)和死亡(48%)中所占比例最大 加利福尼亚州的任何其他种族/民族。此外，拉美裔家庭经历了戏剧性的 由于大流行，家庭粮食不安全增加。这对患有第二型的拉丁裔来说尤其令人痛苦。 糖尿病(T2 DM)作为家庭食物不安全与较差的血糖控制有关，它有生命- 新冠肺炎大流行期间的威胁后果。T2 DM，尤其是控制不佳的T2 DM是一种 新冠肺炎致死的危险因素。有效的多层次干预措施，以改善家庭粮食不安全和 对于患有糖尿病的拉丁裔人来说，迫切需要控制血糖，以缓解由于新冠肺炎造成的差异。这个 阿德兰特的目标(通过提高获得营养的机会来解决糖尿病：有效性的试验)是 确定是否采取多层次干预措施来改善家庭粮食不安全和血糖升高 控制对患有糖尿病的拉丁裔患者有效。我们将使用类型1混合试验来评估 多水平干预对6个月后血糖控制(HbA1c)主要结果的影响。 参与者(n=355)将被随机分为以下两组：1)家庭分娩12周富含纤维的食物 (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 行为干预被称为Vida Sana，或2)等待控制臂，在6个月后接受干预 延迟。我们将对参与者进行为期12个月的跟踪，以评估6个月后HbA1c的初步结果以及 关键的次要结果，如12个月时的糖化血红蛋白，以及6个月和12个月的糖尿病和COVID相关压力 月份。此外，我们将为每名参与者招募最多2名家庭成员，以评估家庭层面 次要结果，如家庭食品不安全、饮食行为和与COVID相关的压力。至 评估实施和传播初级保健多级干预措施的未来潜力 我们将使用混合方法，包括定量措施(例如，干预剂量和保真度)和定性方法 与参与者和主要利益相关者(例如，提供者、诊所领导层、社区支持)进行访谈 农业集团)根据RE-AIM(REACH、有效性、采用、实施和 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 审判。审判将在加利福尼亚州的阿拉米达县进行，那里是一个庞大而多样化的拉丁裔的家园 人口，La Clínica de La Raza，一家在阿拉米达多个地点的社区安全网诊所 县里。这些目标的成功实现将为改进的有效性提供强有力的证据 在大流行期间，拉丁美洲糖尿病患者的家庭食物不安全和血糖控制。