NCT04421755

The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Hypertension
• Nutrition Poor

Interventions

Type	Name	Description
OTHER	Produce delivery	weekly home delivery of fresh fruits and vegetables
OTHER	Cooking classes	weekly home delivery of fresh fruits and vegetables participants will be invited to participate in a Culinary Medicine cooking series. The OU Culinary Medicine cooking curriculum will involve a 3-part class series designed to build nutrition knowledge and cooking self-efficacy for preparing fresh F/Vs. Each session is \~2 hr. Core nutrition guidelines for blood pressure and blood sugar management will also be emphasized informed by an evidence-based Conceptual Model of Healthy Cooking. Classes will be conducted in small groups (\~16 participants) in an established teaching kitchen used by the culinary medicine program. Classes will be facilitated by a professional chef, a healthcare professional (dietitian, medical doctor, or trained medical student), and other support staff, including trained medical, dietetic, and public health students.

Timeline

• Start date: 2019-07-16
• Primary completion: 2021-03-16
• Completion: 2021-03-16
• First posted: 2020-06-09
• Last updated: 2023-01-10

Locations

1 site across 1 country: United States