The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
- Conditions
- DiabetesHypertensionNutrition Poor
- Interventions
- Other: Produce deliveryOther: Cooking classes
- Registration Number
- NCT04421755
- Lead Sponsor
- University of Oklahoma
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Produce + Cooking Classes Produce delivery Receives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes Produce Only Produce delivery Receives weekly home delivery of fresh fruits and vegetables Produce + Cooking Classes 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
- Primary Outcome Measures
Name Time Method Systolic blood pressure Baseline, 3 months, 6 months, 9 months change scores in systolic blood pressure at each time point
Diastolic blood pressure 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 Baseline, 3 months, 6 months, 9 months change scores in A1C at each time point
Food security Baseline, 3 months, 6 months, 9 months change scores on a food security scale
Food environment Baseline, 9 months change scores on a food environment scale
Fruit and vegetable consumption Baseline, 9 months change scores on a fruit and vegetable consumption scale
Nutrition knowledge Baseline, 9 months change scores on a fruit and vegetable consumption scale
Cooking skills Baseline, 9 months change scores on cooking skills scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Schusterman Clinic at the University of Oklahoma Health Science Center
🇺🇸Tulsa, Oklahoma, United States