Clinical trial NCT04421755: The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
Official title: The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Nutrition Poor
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion:

* 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

Exclusion:

* 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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Diastolic blood pressure
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: A1c
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Food security
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Food environment
timeFrame: Baseline, 9 months
measure: Fruit and vegetable consumption
timeFrame: Baseline, 9 months
measure: Nutrition knowledge
timeFrame: Baseline, 9 months
measure: Cooking skills
timeFrame: Baseline, 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Schusterman Clinic at the University of Oklahoma Health Science Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Marianna Wetherill, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: Brent Beasley, MD
role: PRINCIPAL_INVESTIGATOR
References: