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Completed

NCT Number: NCT04421755

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

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Malnutrition Metabolic Diseases Nutrition Disorders Nutrition Poor Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schusterman Clinic at the University of Oklahoma Health Science Center

Tulsa, Oklahoma, 74135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Produce delivery

Other

weekly home delivery of fresh fruits and vegetables

Cooking classes

Other

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.

Primary outcomes

  1. Systolic blood pressure

    Time frame: Baseline, 3 months, 6 months, 9 months

    change scores in systolic blood pressure at each time point

  2. Diastolic blood pressure

    Time frame: 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.

  3. A1c

    Time frame: Baseline, 3 months, 6 months, 9 months

    change scores in A1C at each time point

  4. Food security

    Time frame: Baseline, 3 months, 6 months, 9 months

    change scores on a food security scale

  5. Food environment

    Time frame: Baseline, 9 months

    change scores on a food environment scale

  6. Fruit and vegetable consumption

    Time frame: Baseline, 9 months

    change scores on a fruit and vegetable consumption scale

  7. Nutrition knowledge

    Time frame: Baseline, 9 months

    change scores on a fruit and vegetable consumption scale

  8. Cooking skills

    Time frame: Baseline, 9 months

    change scores on cooking skills scale

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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