The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Systolic blood pressure
研究概览
简要总结
Hypertension and diabetes, which are increasing in prevalence, contribute to significant morbidity and mortality in the U.S. Self-management of these diseases, including adherence to dietary guidelines such as daily fruit and vegetable intake, can improve outcomes, but low-income patients encounter many barriers to adherence, such as food insecurity and poor nutrition literacy. Few clinicians screen for food insecurity, and even when screening is performed, there are few tested clinical response models. This study will evaluate the benefits of fresh fruit and vegetable home delivery program, without and with small-group culinary medicine cooking classes, on blood pressure and glucose control among patients accessing care at the University of Oklahoma Internal Medicine Clinic in Tulsa, OK. The Produce Drop pilot study will evaluate the feasibility and potential health benefits of a clinic-community partnership between OU Internal Medicine and a fresh produce home-delivery service provider, to promote adherence to F/V dietary guidelines among patients with suboptimal blood pressure and blood glucose control. Among half of those assigned to receive food assistance, we will evaluate the additional benefits of participation in 3-session, small-group, hands-on culinary medicine curriculum.
详细描述
a diet rich in fruits and vegetables, is an essential requirement for optimal blood pressure and glucose control. Clinical practice guidelines for hypertension and diabetes both assign the highest grade of evidence for healthy eating behavior to treat these conditions. Unfortunately, fewer than one-quarter of patients adhere to dietary recommendations, with the largest disparities among lower socioeconomic groups and racial minorities. Patient adherence to nutrition guidelines are deeply hindered by poor access to fresh produce and inadequate knowledge about preparing medically-indicated foods. The proposed Produce Drop pilot study will evaluate the feasibility and potential health benefits of a fresh fruit and vegetable home-delivery program, with and without additional small-group culinary medicine cooking classes, among low-income, Medicaid patients with suboptimal blood pressure and glucose control. Patients (n=100) from OU-Tulsa Schusterman Internal Medicine Clinic will be randomized to 1) a fresh fruit and vegetable home-delivery program, or 2) the same home delivery program with supplementary small-group culinary medicine cooking classes. In addition, we will include a third arm of control patients (n=50) who will receive the standard of care. We will track blood pressure and glucose control in all three groups to determine the comparative impact of each intervention. The proposed pilot study, informed by the Institute for Healthcare Improvement's "Triple Aim" framework, will provide the formative information needed to develop a larger-scale intervention to enhance the patient care experience, improve population health status, and reduce the per capita cost of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking;
- •Between 18 - 64 years old;
- •Enrolled in Medicaid at baseline
- •Elevated blood pressure and/or A1C scores in the past three months
- •Access to regular medical care
- •Permission from physician to participate
- •Physical home address that can accept grocery deliveries
- •Lives inside the grocery service delivery area with no intention to move outside of the service areas in the next 9 months
排除标准
- •Non-English speaking
- •Less than 18 years of age or over 64 years of age
- •Serious or terminal illness
- •Pregnant or planning to become pregnant in the next 9 months
- •Advanced end stage renal disease
- •Current enrollment in any other research studies on high blood pressure or diabetes
- •No other household member participating in the study
研究组 & 干预措施
Produce Only
Receives weekly home delivery of fresh fruits and vegetables
干预措施: Produce delivery (Other)
Produce + Cooking Classes
Receives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes
干预措施: Produce delivery (Other)
Produce + Cooking Classes
Receives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes
干预措施: Cooking classes (Other)
Control
Control group with no cooking classes or groceries
结局指标
主要结局
Systolic blood pressure
时间窗: Baseline, 3 months, 6 months, 9 months
change scores in systolic blood pressure at each time point
Diastolic blood pressure
时间窗: Baseline, 3 months, 6 months, 9 months
change scores in diastolic blood pressure at each time point review include age, medications, insurance, A1c, systolic blood pressure, diastolic blood pressure, weight, height, tobacco use, emergency room use, and hospitalizations. Self-report survey items include demographics, insurance, diabetes/pre-diabetes diagnosis date, hypertension diagnosis date, health literacy, medication adherence and medication scrimping, smoking status (Adult Tobacco Survey), food security (USDA 6-item food security survey), grocery shopping; food access (NEMS-P), consumption of fruit and vegetables from weekly delivery , fruit and vegetable intake (f/v checklist), food preparation/eating at home/eating out behaviors, nutrition-related quality of life (NQOL), cooking knowledge, and cooking confidence.
A1c
时间窗: Baseline, 3 months, 6 months, 9 months
change scores in A1C at each time point
Food security
时间窗: Baseline, 3 months, 6 months, 9 months
change scores on a food security scale
Food environment
时间窗: Baseline, 9 months
change scores on a food environment scale
Fruit and vegetable consumption
时间窗: Baseline, 9 months
change scores on a fruit and vegetable consumption scale
Nutrition knowledge
时间窗: Baseline, 9 months
change scores on a fruit and vegetable consumption scale
Cooking skills
时间窗: Baseline, 9 months
change scores on cooking skills scale
次要结局
未报告次要终点