Addressing diabetes by elevating access to nutrition (ADELANTE) - A multi-level approach for improving household food insecurity and glycemic control among Latinos with diabetes: A randomized controlled trial

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-09-23 DOI:10.1016/j.cct.2024.107699

Marcela D. Radtke , Wei-Ting Chen , Lan Xiao , Patricia Rodriguez Espinosa , Marcela Orizaga , Tainayah Thomas , Elizabeth Venditti , Amy L. Yaroch , Kenia Zepada , Lisa G. Rosas , June Tester

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Abstract

Background

Latinx adults are disproportionately impacted by the interrelated challenges of food insecurity and nutrition sensitive chronic diseases. Food and nutrition insecurity can exacerbate the development and progression of chronic diseases, such as diabetes. Sustainable, effective interventions aimed at improving food insecurity and diabetes management for Latinx populations are needed.

Methods

This hybrid type 1 trial evaluates the effectiveness of a multi-level intervention that includes a medically supportive food and behavioral lifestyle program on the primary outcome of Hemoglobin A1c (HbA1c) at 6 months. Latinx adults (n = 355) with type 2 diabetes (HbA1c of 6.0–12.0 %), overweight/obesity (BMI > 25 kg/m²), and self-reported risk of food insecurity will be randomized 1:1 to intervention (12 weekly deliveries of vegetables, fruits, and whole-grain foods + culturally-modified behavioral lifestyle program) versus control (food deliveries after a 6-month delay). Outcome asessments will occur at 0, 6 and 12 months, and include HbA1c, dietary intake, psychosocial health outcomes, and diabetes-related stressors. In addition, food insecurity and the impact of the intervention on up to two household members will be measured. Qualitative interviews with patients, healthcare providers, and community partners will be conducted in accordance with Reach, Effectivenes, Adoption, Implementation, and Maintenence (RE-AIM) framework to identify barriers and best practices for future dissemination.

Conclusions

The ADELANTE trial will provide novel insight to the effectiveness of a multi-level intervention on diabetes-related outcomes in Latinx adults. The mixed-method approach will also identity the reach of this ‘Food is Medicine’ intervention on additional household members to inform diabetes prevention efforts.

Clinical Trial Registration: NCT05228860

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通过提高营养获得率解决糖尿病问题（ADELANTE）--一种改善拉丁裔糖尿病患者家庭粮食不安全和血糖控制的多层次方法：随机对照试验。

背景：拉丁裔成年人受到粮食不安全和营养敏感性慢性病等相互关联的挑战的影响尤为严重。粮食和营养不安全会加剧糖尿病等慢性疾病的发展和恶化。需要采取可持续的有效干预措施来改善拉丁裔人口的粮食不安全状况和糖尿病管理：这项混合型 1 类试验评估了多层次干预措施的效果，其中包括在 6 个月内对血红蛋白 A1c（HbA1c）这一主要结果实施医疗支持性食物和行为生活方式计划。患有 2 型糖尿病（HbA1c 为 6.0-12.0%）、超重/肥胖（体重指数大于 25 kg/m2）且自我报告有粮食不安全风险的拉美裔成年人（n = 355）将按 1:1 的比例随机分配到干预组（每周 12 次提供蔬菜、水果和全谷物食品 + 文化上改进的行为生活方式计划）与对照组（延迟 6 个月后提供食品）。结果评估将在 0 个月、6 个月和 12 个月进行，包括 HbA1c、饮食摄入量、社会心理健康结果和糖尿病相关压力因素。此外，还将评估食物不安全状况以及干预措施对最多两名家庭成员的影响。将根据 "覆盖、效果、采用、实施和维护"（RE-AIM）框架对患者、医疗服务提供者和社区合作伙伴进行定性访谈，以确定未来推广的障碍和最佳实践：结论：ADELANTE 试验将为多层次干预措施对拉丁裔成年人糖尿病相关结果的有效性提供新的见解。混合方法还将确定这种 "食物即药物 "干预措施对更多家庭成员的影响，为糖尿病预防工作提供信息：临床试验注册：NCT05228860。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.