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。吃营养密集的饮食，富含水果和蔬菜(F&V)是2型糖尿病的基石 糖尿病(T2 DM)治疗。然而，在西班牙裔成年人中，只有16%达到了推荐的最低F&V标准 他们的T2 DM患病率高于非西班牙裔白人(16.6%比13.3%， )。F&V处方(F&V Rx)计划嵌入临床环境，针对医疗高危人群 例如T2 DM患者，并向他们提供在当地零售商购买F&V的代金券。 对T2 DM患者进行的初步F&V Rx研究发现，每餐F&V摄入量增加0.2-1.6份 天数和糖化血红蛋白(A1c)从0.35-0.71%[3.8-7.8 mmol/mol]降低。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A1c下降 0.24%~1.0%[2.6~10.9 mmol/mol]。我们的团队进行了一项F&V Rx试点研究，在该研究中，我们激励 副总经理/S出席，在每次会议上提供F&V Rx。尽管DSME/S的接受率通常很低 转介后(约5%-7%)，我们的项目首期出席率为73%。此外，在7个月后- 计划中，我们发现A1c在临床和统计学上显著降低了1.3%[14.2 mmol/mol](p=.001)。 虽然F&V Rx代金券的收到取决于DSME/S是否参加我们的研究，但其他 专注于T2 DM的F&V Rx研究没有DSME/S的出勤要求，他们也看到了A1C 减税。因此，了解F&V Rx对DSME/S摄取和留存的影响 出勤要求是必须评估的关键设计问题。此建议是对PAS 20的回应- 160用于短期、先导性随机对照试验(RCT)，以获得有关试验设计的初步数据。 我们建议为患有T2 DM(A1c&>7%)的低收入成年人(18岁以上)进行为期16周的3臂试验性随机对照试验(n=120)。 摩尔/摩尔])。对照组(n=40)接受常规护理(UC)。两个干预组(n=40) 将获得UC加F&V Rx，该F&V Rx独立于DSME/S出席(仅F&V Rx)或取决于 DSME/S出席(F&V Rx+DSME/S)。首先，我们将系统地探索F&V Rx对 DSME/S的摄取和滞留。接下来，我们将探索A1c的变化，以及与饮食相关的结果。最后，有了 考虑到实施，我们将使用Proctor的实施分类法和文化适应框架 来自Castro等人，与两个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。我们的研究团队和我们的社区咨询委员会(CAB)进行了这项研究， 临床专业知识，以及在低收入西班牙裔美国人中进行F&V Rx试验所需的成熟零售网络 社区。这项试验的结果将为未来全功率随机对照试验的设计提供参考，并填补 我们的知识与F&V Rx计划如何影响T2 DM相关结果相关。如果有效，F&V Rx 这些计划有可能改善糖尿病的自我管理，减轻穷人的临床负担 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.