The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
Primary Purpose
Diabetes, Hypertension, Nutrition Poor
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Produce delivery
Cooking classes
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
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
Sites / Locations
- Schusterman Clinic at the University of Oklahoma Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Produce Only
Produce + Cooking Classes
Control
Arm Description
Receives weekly home delivery of fresh fruits and vegetables
Receives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes
Control group with no cooking classes or groceries
Outcomes
Primary Outcome Measures
Systolic blood pressure
change scores in systolic blood pressure at each time point
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.
A1c
change scores in A1C at each time point
Food security
change scores on a food security scale
Food environment
change scores on a food environment scale
Fruit and vegetable consumption
change scores on a fruit and vegetable consumption scale
Nutrition knowledge
change scores on a fruit and vegetable consumption scale
Cooking skills
change scores on cooking skills scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04421755
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 16, 2019 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Hypertension, Nutrition Poor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Produce Only
Arm Type
Experimental
Arm Description
Receives weekly home delivery of fresh fruits and vegetables
Arm Title
Produce + Cooking Classes
Arm Type
Experimental
Arm Description
Receives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group with no cooking classes or groceries
Intervention Type
Other
Intervention Name(s)
Produce delivery
Intervention Description
weekly home delivery of fresh fruits and vegetables
Intervention Type
Other
Intervention Name(s)
Cooking classes
Intervention Description
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 Outcome Measure Information:
Title
Systolic blood pressure
Description
change scores in systolic blood pressure at each time point
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Diastolic blood pressure
Description
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.
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
A1c
Description
change scores in A1C at each time point
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Food security
Description
change scores on a food security scale
Time Frame
Baseline, 3 months, 6 months, 9 months
Title
Food environment
Description
change scores on a food environment scale
Time Frame
Baseline, 9 months
Title
Fruit and vegetable consumption
Description
change scores on a fruit and vegetable consumption scale
Time Frame
Baseline, 9 months
Title
Nutrition knowledge
Description
change scores on a fruit and vegetable consumption scale
Time Frame
Baseline, 9 months
Title
Cooking skills
Description
change scores on cooking skills scale
Time Frame
Baseline, 9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianna Wetherill, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brent Beasley, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schusterman Clinic at the University of Oklahoma Health Science Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
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