The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
Condition: Diabetes; Hypertension; Nutrition Poor
MeSH terms: Malnutrition
Study type: Interventional

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.
    

Intervention name(s): Produce delivery; Cooking classes
Intervention type(s): Other; Other
Intervention description(s): weekly home delivery of fresh fruits and vegetables; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: A randomized control trial will be used to evaluate the two interventions among a cohort of OU Internal Medicine patients. Clinical and self-report measures will be collected for the intervention arms at four time points: baseline, three months, six months, and nine months and at two time points (baseline and nine months) for the control group. After baseline measures, participants will be randomly assigned to the fruits and vegetables only group, the fruit and vegetables plus cooking classes group, or the control group. This trial will use rolling enrollment, with interventions beginning after the enrollment of enough participants to conduct an effective cooking class. Participants in the intervention groups will receive nine months of free weekly deliveries of fresh fruits and vegetables. Participants in the control group will receive a gift card valued at twenty dollars for each survey completed and an OU gift valued at ten dollars following completion of both surveys.
Masking: None (Open Label)
Primary purpose: Treatment