DiabetesNCT04421755
The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
A study testing Produce delivery and Cooking classes in people with Diabetes and Hypertension, run by University of Oklahoma at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes, Hypertension, Nutrition Poor
- What is being tested?
- Produce delivery and Cooking classes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 16 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Schusterman Clinic at the University of Oklahoma Health Science Center
Tulsa, Oklahoma, 74135
About this study
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.
Read the 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.
- Conditions
- Diabetes, Hypertension, Nutrition Poor
- Being tested
- Produce delivery, Cooking classes
- Medical subject headings
- Diabetes Mellitus, Hypertension, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Produce deliveryOther
weekly home delivery of fresh fruits and vegetables
Cooking classesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Produce Only | Experimental | Receives weekly home delivery of fresh fruits and vegetables Receives: 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 Receives: Other: Produce delivery; Other: Cooking classes |
| Control | No intervention | Control group with no cooking classes or groceries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
change scores in systolic blood pressure at each time point
Measured: 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.
Measured: Baseline, 3 months, 6 months, 9 months
A1c
change scores in A1C at each time point
Measured: Baseline, 3 months, 6 months, 9 months
Food security
change scores on a food security scale
Measured: Baseline, 3 months, 6 months, 9 months
Food environment
change scores on a food environment scale
Measured: Baseline, 9 months
Fruit and vegetable consumption
change scores on a fruit and vegetable consumption scale
Measured: Baseline, 9 months
Nutrition knowledge
change scores on a fruit and vegetable consumption scale
Measured: Baseline, 9 months
Cooking skills
change scores on cooking skills scale
Measured: Baseline, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start16 Jul 2019
- Primary completion16 Mar 2021
- Study completion16 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianna Wetherill, PhD, Principal investigator, University of OklahomaBrent Beasley, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421755
- Sponsor's protocol ID
- 10360
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Produce Drop: Using Food as Medicine to Lower A1C Levels and Blood Pressure
- ClinicalTrials.gov ID
- NCT04421755
- Acronym / sponsor ID
- 10360
- Conditions
- Diabetes, Hypertension, Nutrition Poor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Mar 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Produce Only | Experimental | Other: Produce deliveryReceives weekly home delivery of fresh fruits and vegetables |
| Produce + Cooking Classes | Experimental | Other: Produce delivery, Other: Cooking classesReceives weekly home delivery of fresh fruits and vegetables plus invitation to participate in a series of three small group culinary medicine cooking classes |
| Control | No intervention | –Control group with no cooking classes or groceries |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Produce deliveryweekly home delivery of fresh fruits and vegetables | Other | Produce + Cooking Classes, Produce Only |
| Cooking classesweekly 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. | Other | Produce + Cooking Classes |
Primary outcome
Systolic blood pressure
Time frame: Baseline, 3 months, 6 months, 9 months
change scores in systolic blood pressure at each time point
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.
A1c
Time frame: Baseline, 3 months, 6 months, 9 months
change scores in A1C at each time point
Food security
Time frame: Baseline, 3 months, 6 months, 9 months
change scores on a food security scale
Food environment
Time frame: Baseline, 9 months
change scores on a food environment scale
Fruit and vegetable consumption
Time frame: Baseline, 9 months
change scores on a fruit and vegetable consumption scale
Nutrition knowledge
Time frame: Baseline, 9 months
change scores on a fruit and vegetable consumption scale
Cooking skills
Time frame: Baseline, 9 months
change scores on cooking skills scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianna Wetherill, PhD principal investigator
University of Oklahoma
Brent Beasley, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Produce delivery and Cooking classes in people with Diabetes and Hypertension, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: Baseline, 3 months, 6 months, 9 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.