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.

摘要：食用富含水果和蔬菜 (F&V) 的营养丰富的饮食是 2 型饮食的基石。 然而，在西班牙裔成年人中，只有 16% 达到建议的最低 F&V 治疗。 摄入量建议，他们的 T2DM 发病率高于非西班牙裔白人（16.6% 对 13.3%， F&V 处方 (F&V Rx) 计划嵌入临床环境，针对医疗高风险 患者，例如 T2DM 患者，并向他们提供在当地零售商购买 F&V 的代金券。 针对 T2DM 患者的初步 F&V Rx 研究发现，每份 F&V 摄入量增加 0.2-1.6 份 日和血红蛋白 A1c (A1c) 降低 0.35-0.71% [3.8 -7.8 mmol/mol] 然而，这些都没有。 研究包括糖尿病自我管理教育和支持 (DSME/S)，这可能导致 A1c 降低 从 0.24% 到 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，我们对此进行了激励。 DSME/S 通过在每次会议上提供 F&V Rx 来出席，尽管 DSME/S 的参与度通常非常低。 转介后（约 5-7%），我们的项目首次会议的出席率在 7 个月后达到了 73%。 计划中，我们发现 A1c 在临床和统计学上显着降低了 1.3% [14.2 mmol/mol] (p=.001)。 尽管 F&V Rx 优惠券的收到取决于 DSME/S 是否参加我们的研究，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 因此，了解 F&V Rx 在有或没有情况下对 DSME/S 吸收和保留的影响。 出勤要求是必须评估的关键设计问题，该提案是为了响应 PAS 20-。 160 用于短期试点随机对照试验 (RCT)，以获得有关试验设计的初步数据。 我们建议针对患有 T2DM (A1c >7%) 的低收入成年人（18 岁以上）开展一项 3 组、为期 16 周的试点随机对照试验 (n=120) [53 mmol/mol]）。对照组（n=40）将接受常规护理（UC），两个干预组（n=40）。 将收到 UC 加上 F&V Rx，该 F&V Rx 独立于 DSME/S 出勤（仅 F&V Rx）或依赖 首先，我们将系统地探讨 F&V Rx 对 DSME/S 出勤率的影响。 接下来，我们将探讨 A1c 的变化以及饮食相关的结果。 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，与双方参与者一起评估计划的适当性、可接受性和可持续性 我们的研究团队和社区咨询委员会 (CAB) 进行了研究， 临床专业知识，以及在低收入西班牙裔人群中进行 F&V Rx 试验所需的已建立的零售网络 该试验的结果将为未来的、功能齐全的随机对照试验的设计提供信息，并解决现有技术中的差距。 我们了解 F&V Rx 计划如何影响 T2DM 相关结果。 项目有潜力改善糖尿病自我管理并减轻贫困的临床负担 血糖控制，特别是在低收入的西班牙裔社区。