Short Eliza, Selig James P, Felix Holly C, Painter Jacob, McElfish Pearl A, Rowland Brett, Ammerman Alice S, Bounds Kelsey, Henske Joseph, Hudson Jonell S, Li Ji, Young Sean G, Long Christopher R
Gretchen Swanson Center for Nutrition, 14301 FNB Parkway, Suite 100, Omaha, NE 68154, USA.
Fay W. Boozman College of Public Health, University of Arkansas for Medical Sciences Northwest, 2708 S. 48(th) St., Springdale, AR 72762, USA.
Contemp Clin Trials. 2024 May;140:107491. doi: 10.1016/j.cct.2024.107491. Epub 2024 Mar 6.
Rural populations experience a higher prevalence of both food insecurity and type 2 diabetes mellitus (T2DM) than metropolitan populations and face many challenges in accessing resources essential to optimal T2DM self-management. This study aims to address these challenges by delivering a T2DM-appropriate food box and recipes directly to rural participants' homes.
This is a comparative effectiveness randomized controlled trial including 400 English- or Spanish-speaking rural adult participants with T2DM (HbA1c ≥6.5%) experiencing food insecurity. Participants are randomly assigned to a 3-month Healthy Food Delivery Intervention (HFDI) plus one 60-min virtual consultation with a diabetes educator or consultation only. The HFDI includes a weekly food box delivery with recipes. Data are collected at pre-intervention, 3-months (post-intervention), 9-months, and 15-months. The primary outcome is change in HbA1c, with secondary measures including diet quality (Healthy Eating Index-2015, calculated from one 24-h dietary recall at each data collection time point), cardio-metabolic risk factors (i.e., blood pressure, lipids, body mass index, glucose), and patient-centered outcomes (e.g., T2DM self-efficacy, T2DM-related distress). Process evaluation data (e.g., successful food box deliveries, diabetes educator consultation attendance, intervention satisfaction) are collected during and post-intervention (3-months). A cost-effectiveness analysis based on traditional cost per quality-adjusted life year gain thresholds will be conducted to estimate the incremental cost-effectiveness between HFDI plus consultation and consultation alone.
Findings from this study will provide evidence regarding the effectiveness of an intervention that promotes participant adherence and improves access to healthy food.
NCT04876053.
农村人口面临粮食不安全和2型糖尿病（T2DM）的患病率高于城市人口，并且在获取T2DM最佳自我管理所需资源方面面临诸多挑战。本研究旨在通过直接向农村参与者家中提供适合T2DM的食物盒和食谱来应对这些挑战。
这是一项比较效果随机对照试验，纳入400名有粮食不安全问题、讲英语或西班牙语的农村成年T2DM患者（糖化血红蛋白≥6.5%）。参与者被随机分配到为期3个月的健康食品递送干预（HFDI）组，加上与糖尿病教育者进行一次60分钟的虚拟咨询，或仅接受咨询组。HFDI包括每周递送一次装有食谱的食物盒。在干预前、3个月（干预后）、9个月和15个月时收集数据。主要结局是糖化血红蛋白的变化，次要指标包括饮食质量（2015年健康饮食指数，根据每个数据收集时间点的一次24小时饮食回忆计算）、心血管代谢危险因素（即血压、血脂、体重指数、血糖）和以患者为中心的结局（如T2DM自我效能、T2DM相关困扰）。在干预期间和干预后（3个月）收集过程评估数据（如食物盒成功递送情况、糖尿病教育者咨询出席情况、干预满意度）。将进行基于传统每质量调整生命年增益阈值成本效益分析，以估计HFDI加咨询与仅咨询之间的增量成本效益。
本研究结果将为促进参与者依从性并改善健康食品获取的干预措施的有效性提供证据。
NCT04876053。
