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

NCT04421755 | Completed

• 1 other identifier: 10360
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension; Nutrition Poor

Outcome Measures

Primary Outcomes (8)

• Systolic blood pressure

  change scores in systolic blood pressure at each time point

  Baseline, 3 months, 6 months, 9 months

• Diastolic blood pressure

  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.

  Baseline, 3 months, 6 months, 9 months

• A1c

  change scores in A1C at each time point

  Baseline, 3 months, 6 months, 9 months

• Food security

  change scores on a food security scale

  Baseline, 3 months, 6 months, 9 months

• Food environment

  change scores on a food environment scale

  Baseline, 9 months

• Fruit and vegetable consumption

  change scores on a fruit and vegetable consumption scale

  Baseline, 9 months

• Nutrition knowledge

  change scores on a fruit and vegetable consumption scale

  Baseline, 9 months

• Cooking skills

  change scores on cooking skills scale

  Baseline, 9 months

Study Arms (3)

Produce Only

EXPERIMENTAL

Receives weekly home delivery of fresh fruits and vegetables

Other: Produce delivery

Produce + Cooking Classes

EXPERIMENTAL

Receives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes

Other: Produce delivery; Other: Cooking classes

Control

NO INTERVENTION

Control group with no cooking classes or groceries

Interventions

Produce delivery OTHER

weekly home delivery of fresh fruits and vegetables

Produce + Cooking Classes; Produce Only

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.

Produce + Cooking Classes

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Schusterman Clinic at the University of Oklahoma Health Science Center

Tulsa, Oklahoma, 74135, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Malnutrition

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders

Study Officials

• Marianna Wetherill, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Brent Beasley, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: June 9, 2020
• Study Start: July 16, 2019
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)