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.

项目摘要 拉丁美洲人占SARS-COV-2（COVID-19）案件（60％）和死亡（48％）的最大份额 加利福尼亚的任何其他种族/族裔。此外，拉丁裔家庭经历了戏剧性的 由于大流行而增加家庭粮食不安全感。对于2型拉丁美洲人来说，这尤其令人痛苦 糖尿病（T2DM）作为家庭粮食不安全性与较差的血糖控制有关，血糖控制具有生命 - 19009年大流行期间的威胁后果。 T2DM，尤其是控制不良的T2DM，是一个 COVID-19的死亡风险因素。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迫切需要血糖控制，以减轻19.19造成的差异。 阿德兰特的目标（通过提升营养的机会来解决糖尿病：有效性的试验）是 确定多层干预措施是否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型混合动力试验来评估 多层干预对血糖控制（HBA1C）主要结果（6个月）的有效性。 参与者（n = 355）将被随机分配给：1）纤维丰富的食物的12周 （蔬菜，豆类/豆类和全谷物）再加上12个月的遥远，适应文化的生活方式 行为干预称为VIDA SANA，或2）候补控制臂，在6个月后接受干预 延迟。我们将关注参与者12个月，以评估6个月时HBA1C的主要结果 关键的次要结果，例如12个月的HBA1C，以及6和12时与糖尿病和相关应力 月份。此外，我们将为每个参与的最多2个家庭成员招募，以评估家庭级别 次要结果，例如家庭粮食不安全，饮食行为和相关的压力。到 评估实施和传播多层次干预初级保健的未来潜力 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 与参与者和主要利益相关者的访谈（例如提供者，诊所领导，社区支持 农业集团）根据RE-AIM（覆盖，有效性，采用，实施和 维护）框架。我们将使患者和长期的社区合作伙伴参与 试验。该审判将在加利福尼亚州的阿拉米达县举行，该县是拉丁裔大型和潜水员的所在地 人口，在拉拉扎（La Raza），一个社区安全网诊所 县。这些目标的成功完成将为改善有效性提供可靠的证据 大流行期间，拉丁美洲裔糖尿病的家庭食品不安全和血糖控制。