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的营养丰富的饮食是2型糖尿病的基础