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: 10309810
• 负责人: Lisa Goldman Rosas
• 金额: $ 67万
• 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/10309810
• 关键词: 2019-nCoV; Address; Adolescent; Adopted; Adult; Agriculture; Behavior; Behavior Therapy; COVID-19; COVID-19 mortality; COVID-19 pandemic; California; Calories; Cessation of life; Clinic; Communities; Control Groups; County; Diabetes Mellitus; Diet; Dietary Fiber; Dissemination and Implementation; Distress; Dose; Effectiveness; Effectiveness of Interventions; Ethnic group; Fabaceae; Family member; Farming environment; Fiber; Food; Future; Gender; Glycosylated hemoglobin A; Goals; Government; Government Programs; Health Food; Hispanics; Home; Household; Immigration; Individual; Intake; Intervention; Interview; Latino; Leadership; Life; Life Style; Location; Loneliness; Measures; Mediator of activation protein; Methods; Neighborhood Health Center; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Overweight; Participant; Patients; Persons; Phase; Primary Health Care; Provider; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Risk Factors; Rotation; Social support; Stress; Testing; Time; United States; Vegetables; Waiting Lists; arm; bean; coping; coronavirus disease; cost; depressive symptoms; design; diabetes control; dietary; 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 and ethnic; 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.

项目概要 与其他国家相比，拉丁美洲人在 SARS-CoV-2 (COVID-19) 病例 (60%) 和死亡人数 (48%) 中所占比例最大 此外，与加利福尼亚州的任何其他种族/族裔群体相比，拉丁裔家庭也经历了戏剧性的变化。 由于大流行，家庭粮食不安全状况加剧，这对于患有 2 型流感的拉丁美洲人来说尤其令人痛苦。 糖尿病（T2DM），因为家庭粮食不安全与血糖控制较差有关，这会影响生命 T2DM，尤其是控制不佳的 T2DM，是一种 COVID-19 死亡的危险因素，以改善家庭粮食不安全和 拉丁裔糖尿病患者迫切需要控制血糖，以缩小因 COVID-19 造成的差异。 ADELANTE（通过提高营养获取来解决糖尿病：有效性试验）的目标是 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水平 控制对拉丁裔糖尿病患者有效，我们将使用 1 型混合试验来评估。 多层次干预对 6 个月时血糖控制 (HbA1c) 主要结局的有效性。 参与者 (n=355) 将被随机分配到以下任一组：1) 12 周家庭提供富含纤维的食物 （蔬菜、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 称为 Vida Sana 的行为干预，或 2) 候补控制组，在 6 个月后接受干预 我们将跟踪参与者 12 个月，以评估 6 个月时的 HbA1c 主要结果。 关键的次要结局，例如 12 个月时的 HbA1c，以及 6 个月和 12 个月时与糖尿病和新冠病毒相关的压力 此外，我们将为每个参与者招募最多 2 名家庭成员来评估家庭水平。 次要结果，例如家庭粮食不安全、饮食行为和与新冠病毒相关的压力。 评估初级保健多层次干预措施的未来实施和传播潜力 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）和定性测量 与参与者和主要利益相关者（例如提供者、诊所领导、社区支持的 农业集团）根据 RE-AIM（范围、有效性、采用、实施和 我们将让患者和我们的长期社区合作伙伴参与所有阶段。 审判将在加利福尼亚州阿拉米达县进行，该县是大量多元化拉丁裔的家乡。 La Clínica de La Raza 是一家社区安全网诊所，在阿拉米达设有多个地点 县的成功完成这些目标将为改进的有效性提供有力的证据。 大流行期间拉丁裔糖尿病患者的家庭粮食不安全和血糖控制。