Veggie Rx: A pilot, 3-arm randomized controlled trial of a fruit and vegetable prescription program for patients with type two diabetes

抽象的。食用营养丰富的饮食，富含水果和蔬菜（F& V）是2型的基石 糖尿病（T2 DM）治疗。然而，在西班牙裔成年人中，只有16%的人达到了建议的最低F&V 他们的T2 DM发病率高于非西班牙裔白人（16.6%对13.3%， 分别）。F&V处方（F&V Rx）计划嵌入临床环境，针对医学高风险 我们亦会向糖尿病患者（例如T2 DM患者）提供食物及饮品的优惠券，让他们在本地零售商购买食物及饮品。 在T2 DM患者中进行的初步F&V Rx研究发现， 天，血红蛋白A1 c（A1 c）降低0.35-0.71% [3.8 - 7.8 mmol/mol]。然而，这些都不是 研究包括糖尿病自我管理教育和支持（DSME/S），这可能导致A1 c降低 0.24%至1.0% [2.6-10.9 mmol/mol]。我们的团队进行了一项试点F&V Rx研究， DSME/S出席，在每次会议上提供F&V Rx。尽管DSME/S吸收通常非常低， 在转介后（约5-7%），我们的方案有73%的首次会议出席率。此外，在术后7个月， 在该程序中，我们发现A1 c的临床和药理学显著降低1.3% [14.2 mmol/mol]（p=.001）。 虽然F&V Rx代金券的接收取决于DSME/S是否参加我们的研究，但其他 以T2 DM为重点的F&V Rx研究没有DSME/S出勤要求，他们也看到了A1 c 减少。因此，了解F&V Rx对DSME/S摄取和保留的影响， 出勤要求是必须评估的关键设计问题。这一建议是对PAS 20的回应- 160项短期、初步随机对照试验（RCT），以获取有关试验设计的初步数据。 我们提出了一项针对低收入成年人（18岁以上）T2 DM（A1 c>7%）的3组、16周试点随机对照试验（n=120）[53 mmol/mol]）。对照组（n=40）将接受常规护理（UC）。两个干预组（每组n=40） 将获得UC加上F&V Rx，该Rx独立于DSME/S出勤（仅F&V Rx）或依赖于 关于DSME/S出勤率（F&V Rx + DSME/S）。首先，我们将系统地探讨F&V Rx对 DSME/S中的吸收和保留。接下来，我们将探讨A1 c的变化和饮食相关的结果。最后以 考虑到实现，我们将使用普罗克特的实现分类法和文化适应框架 从Castro等人，与双方参与者一起评估计划的适当性、可接受性和可持续性 和临床护理提供者。我们的研究小组和我们的社区咨询委员会（CAB）进行了研究， 临床专业知识，并建立必要的零售网络，在低收入，西班牙裔， 社区这项试验的结果将为未来的充分把握度RCT的设计提供信息，并解决 我们的知识与F&V Rx计划如何影响T2 DM相关结果有关。如果有效，F&V Rx 项目有可能改善糖尿病自我管理，减少穷人的临床负担。 血糖控制，特别是在低收入的西班牙裔社区。

Abstract. Consuming a nutrient-dense diet, rich in fruits and vegetables (F&Vs) is at the cornerstone of type 2 diabetes (T2DM) treatment. Yet, among Hispanic adults, only 16% meet the recommended minimum F&V intake recommendations and they have higher rates of T2DM than non-Hispanic whites (16.6% versus 13.3%, respectively). F&V Prescription (F&V Rx) programs are embedded in clinical settings, target medically high-risk patients such as those with T2DM, and provide them with vouchers to purchase F&V at local retailers. Preliminary F&V Rx studies in patients with T2DM have found F&V intake increases of 0.2-1.6 servings per day and hemoglobin A1c (A1c) reductions from 0.35-0.71% [3.8 -7.8 mmol/mol]. However, none of these studies included diabetes self-management education and support (DSME/S) which can lead to A1c decreases from 0.24% to 1.0% [2.6-10.9 mmol/mol]. Our team conducted a pilot F&V Rx study where we incentivized DSME/S attendance by providing a F&V Rx at each session. Although DSME/S uptake is typically very low after referral (around 5-7%), our program had a 73% first session attendance rate. Further, at 7 months post- program, we found a clinically- and statistically-significant reduction in A1c of 1.3% [14.2 mmol/mol] (p=.001). Although the receipt of the F&V Rx vouchers was contingent upon DSME/S attendance in our study, other T2DM-focused F&V Rx studies did not have DSME/S attendance requirements and they also saw A1c reductions. Thus, understanding the effect of a F&V Rx on DSME/S uptake and retention with and without attendance requirements is a key design issue that must be evaluated. This proposal is in response to PAS 20- 160 for short-term, pilot randomized controlled trials (RCTs) to acquire preliminary data regarding trial design. We propose a 3-Arm, 16-week, pilot RCT (n=120) for low-income adults (aged 18+) with T2DM (A1c >7% [53 mmol/mol]). The control group (n=40) will receive usual care (UC). The two intervention groups (n=40 each) will receive UC plus a F&V Rx that is either independent of DSME/S attendance (F&V Rx alone) or dependent on DSME/S attendance (F&V Rx + DSME/S). First, we will systematically explore the impact of a F&V Rx on uptake and retention in DSME/S. Next, we will explore changes in A1c, and diet-related outcomes. Finally, with implementation in mind, we will use Proctor’s implementation taxonomy, and the cultural adaptation framework from Castro et al., to assess program appropriateness, acceptability, and sustainability with both participants and clinical care providers. Our study team and our Community Advisory Board (CAB) have the research, clinical expertise, and established retail network necessary to conduct a F&V Rx trial in a low-income, Hispanic community. The findings of this trial will inform the design of a future, fully powered RCT and address gaps in our knowledge related to how F&V Rx programs impact T2DM-related outcomes. If effective, F&V Rx programs have the potential to improve diabetes self-management and reduce the clinical burden of poor glycemic control, particularly in low-income, Hispanic communities.