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

Veggie Rx：针对二型糖尿病患者的水果和蔬菜处方计划的试点、三组随机对照试验

• 批准号: 10735542
• 负责人: Susan Veldheer
• 金额: $ 33.46万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10735542
• 关键词: Address; Adult; Calories; Caring; Carotenoids; Clinic; Clinical; Clinical Trials; Communities; Consumption; Control Groups; Data; Diabetes Mellitus; Diet; Dietary intake; Disease; Education; Enrollment; Ethnic Origin; Evaluation; Faculty; Fatty acid glycerol esters; Food; Future; Glycosylated hemoglobin A; Healthy Eating; Hispanic; Hour; Household; Incentives; Intake; Intervention; Knowledge; Low Income Population; Low income; Measures; Medicaid; Medical; Methodology; Mind; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Nutrient; Outcome; Participant; Pathway interactions; Patients; Pharmaceutical Preparations; Plasma; Process; Proctor framework; Program Appropriateness; Race; Randomized, Controlled Trials; Recommendation; Research; Surveys; Taxonomy; Testing; Work; aged; arm; blood glucose regulation; care providers; clinical care; cost; design; diabetes self-management; dietary guidelines; food insecurity; food security; fruits and vegetables; glycemic control; group intervention; high risk; hispanic community; implementation outcomes; implementation science; improved; indexing; innovation; nutrition; primary care clinic; programs; response; sex; sociodemographic factors; sociodemographics; sugar; treatment as usual; treatment planning; trial design; uptake; usual care arm; voucher

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.

抽象的。食用富含水果和蔬菜（F＆V）的营养丰富饮食是2型的基石 糖尿病（T2DM）治疗。然而，在西班牙裔成年人中，只有16％的人满足建议的最低F＆V 摄入建议和T2DM的速率高于非西班牙裔白人（16.6％对13.3％， F＆V处方（F＆V RX）程序嵌入到临床环境中，目标医学高风险 诸如具有T2DM的患者，并为他们提供当地零售商购买F＆V的优惠券。 T2DM患者的初步F＆V RX研究发现，f＆v摄入量增加了0.2-1.6份 DAY和血红蛋白A1C（A1C）从0.35-0.71％降低[3.8 -7.8 mmol/mol]。但是，这些都不 研究包括糖尿病自我管理教育和支持（DSME/S），可能导致A1C下降 从0.24％至1.0％[2.6-10.9 mmol/mol]。我们的团队进行了试点F＆V RX研究，我们激励了 DSME/s的出勤率通过在每个会话中提供F＆V RX。尽管DSME/S的吸收通常非常低 转诊（约5-7％）后，我们的计划的第一会议出勤率为73％。此外，在7个月后 - 程序，我们发现A1C的临床和统计学上有显着降低为1.3％[14.2 mmol/mol]（p = .001）。 尽管F＆V RX代金券的收到取决于DSME/S的出勤率，但其他 以T2DM为重点的F＆V RX研究没有DSME/S出勤要求，他们还看到了A1C 减少。这是，了解F＆V RX对DSME/S的吸收和保留的影响 出勤要求是必须评估的关键设计问题。该建议是对PAS 20-的回应 160对于短期，试点随机对照试验（RCT），以获取有关试验设计的初步数据。 我们建议使用T2DM的低收入成年人（A1C> 7％[53 mmol/mol]）。对照组（n = 40）将获得常规护理（UC）。两个干预组（n = 40个） 将获得UC和F＆V RX，该F＆V RX要么独立于DSME/S出席（单独使用F＆V RX）或依赖 在DSME/S出席率（F＆V RX + DSME/S）上。首先，我们将系统地探索F＆V RX对 DSME/s的吸收和保留。接下来，我们将探索A1C的变化以及与饮食相关的结果。最后，与 考虑到实施，我们将使用Proctor的实施分类法和文化适应框架 从Castro等人来评估两位参与者的计划适当性，可接受性和可持续性 和临床护理提供者。我们的学习团队和社区顾问委员会（CAB）进行了研究， 临床专业知识，并建立了在低收入的西班牙裔中进行F＆V RX试验所必需的零售网络 社区。该试验的发现将为未来，全功率RCT的设计提供信息，并解决差距 我们的知识与F＆V RX程序如何影响与T2DM相关的结果有关。如果有效，F＆V RX 计划有可能改善糖尿病自我管理并减少贫困的临床燃烧 血糖控制，特别是在低收入的西班牙裔社区。