A Prescription for Health Equity: A Healthcare Provider-based Produce Prescription Program for People With Prediabetes and Type 2 Diabetes

August 9, 2023 updated by: Griffin Hospital

The goal of this project is to co-design a healthcare provider-based produce prescription program (PPR) in partnership with the community served to improve participants' food security status, diet quality, and cardio-metabolic health outcomes, and to reduce healthcare costs, specifically related to medication use and hospital visits. Novel to this study is an implementation of a community co-designed randomized controlled trial (RCT) with a delayed intervention control group focused of equity (i.e., including the target population in the intervention designed for them) in design, implementation, and evaluation. The project will be conducted in 3 phases. Phase 1 will involve formative research and PPR co-design with community partners and potential participants through listening sessions, partner meetings, and community advisory group sessions to finalize the intervention protocol and components, for which investigators will then request IRB approval. Phase 2 will involve the implementation of a delayed intervention RCT PPR. Data analysis and final reporting will be conducted during Phase 3.

Specific Aims:

In collaboration with community partners and community members, utilize implementation science strategies to identify and address community, systemic, and structural barriers and assets to co-design a tailored produce prescription program (PPR) intervention that emphasizes health equity in a low-income population served by Griffin Hospital (GH) and/or Griffin Faculty Physicians (GFP).

Hypothesis: Collaborating with our community partners on the design and implementation of a PPR will lead to a successful design and implementation of the PPR to our population of focus, as evidenced by satisfaction, retention, experiences of dignity/respect, improved self-efficacy related to fruit and vegetable consumption, and diet quality.

Demonstrate improvements, in intervention group vs delayed intervention control group, in food security status, diet quality, and cardio-metabolic outcomes in individuals with prediabetes or type 2 diabetes through implementation of a tailored PPR in a low-income population served by GH and/or GFP.

Hypothesis: The PPR designed with community input will improve food security status, diet quality, self-reported health related quality of life and cardio-metabolic outcomes (Hemoglobin A1C, weight/body mass index, lipids, blood pressure), among our intervention participants compared with a control over a 6-month period.

Evaluate the impact of a tailored PPR on healthcare cost among low-income participants with prediabetes or type 2 diabetes.

Hypothesis: The successful implementation of the tailored PPR will lead to a reduction in certain healthcare cost specifically related to medication usage (including dose) and reduction in emergency department visit and/or hospitalization among intervention participants compared with a control over a 6-month period.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The risk of nutrition-related chronic diseases is significantly higher in low-income populations when compared with those with higher incomes. Over the course of the last century, the American diet has shifted toward higher consumption of sugar, saturated fat, added sodium, processed foods, and overall calories, while intake of fresh fruits and vegetables has starkly declined. These dietary shifts parallel the rapid rise in the national prevalence of obesity, cardiovascular disease and type 2 diabetes. With among 1 in 3 adults in the United States currently affected by obesity and over 30 million Americans (1 in 10) with type 2 diabetes, there is a growing need to invest resources in prevention and treatment. Diabetes is considered the seventh leading cause of death and is associated with $327 billion yearly in excess medical costs and lost productivity. Obesity, diabetes rates and diet quality are all associated with socioeconomic status and disparately impact low-income, Black and Hispanic persons compared to their higher-income or white counterparts.

Increasing the consumption of fruits and vegetables can improve health by promoting healthy weight and reducing blood sugar, the risk of heart disease, stroke, some types of cancer, and digestive problems. Studies have shown that even without reducing caloric consumption, increasing fruit and vegetable consumption can provide independent benefits by increasing fiber intake, reducing sodium and fat intake, and increasing the micronutrient content of the consumer's diet. There are grave disparities in access to healthy foods based on income, race, geographic location, and immigration status, which in turn drive disparities in obesity, diabetes, overall health, and quality of life.

Fruit and vegetable incentive programs are a prudent method of improving food security, while not investing in or allocating money for poor nutritional quality food. They guarantee that the money spent goes to fruits and vegetables known to improve nutritional status, and a growing body of evidence demonstrates that money allocated to the purchase of fruits and vegetables can improve diet quality, purchasing patterns and sometimes health in a statistically and clinically significant manner. Produce prescription programs have the potential to reduce health disparities resulting from differential access to healthy food. In addition to providing free or discounted access to produce, many PPRs also attempt to address other cultural and socio-contextual barriers to accessing healthy food by providing educational and skill-building programming such as cooking demonstrations, suggested family meal plans, and nutritional information at the point of purchase. The few studies that examine the effectiveness of PPRs suggest that they are associated with dietary improvements and reductions in food insecurity. Overall, fruit and vegetable incentive programs have demonstrated positive impact (with few studies reporting no impact or minimal impact) on fruit and vegetable intake and or diet quality, reduced hemoglobin A1C, and reduced body weight.

Fruit and vegetable incentive programs are designed to increase the budget share available to a household for the purchase of fruits and vegetables.14 Incentive programs have the ability to immediately increase fruit and vegetable purchases, although the benefits of increasing fruit and vegetable purchases and consumption might take longer to realize. Incentives make it possible to encourage healthier purchasing patterns that are necessary for longer term behavior change that leads to improved health status. According to a 2020 meta-analysis conducted by Engel and Ruder, overall, fruit and vegetable incentive programs have a demonstrated benefit on fruit and vegetable purchase patterns.14 In Connecticut's Lower Naugatuck Valley (LNV), poverty and low-income rates (8% and 21%, respectively, in 2017) have been increasing across the region since 2000, according to a 2019 report on community well-being in the LNV. The seven communities (Ansonia, Beacon Falls, Derby, Naugatuck, Oxford, Seymour, and Shelton) of the LNV have a combined population of approximately 140,000, with increasing racial and ethnic diversity. Food insecurity and nutrition-related chronic disease are significant issues among the area's residents, with 12% of adults reporting food insecurity. Nutrition related chronic diseases such as obesity (affecting 28% of the population) are high. Heart disease and diabetes are among the eight leading causes of premature death and account for an average of 14 and 15 years of potential life lost per disease, respectively.

Study Type

Interventional

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age 18 years or older
  2. a patient of GH and/or GFP
  3. diagnosis of prediabetes or Type 2 diabetes consistent with the American Diabetes Association diagnostic criteria
  4. low-income and eligible for SNAP (Supplemental Nutrition Assistance Program, formerly known as Food Stamps) and/or Medicaid.

Exclusion Criteria:

  1. inability to speak English or Spanish
  2. having had gastric bypass or other bariatric surgeries
  3. having an eating disorder, or other substantial, clinical dietary restrictions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Group
The PPR intervention will span 6 months and will include 2 main components: produce vouchers and nutrition education.
Other: Produce Prescription Group

Participants will receive vouchers equal to $40/household/month, with an additional $5/month per additional household member, for the purchase of fresh fruits and vegetables during the six-month intervention period. The vouchers will be administered in the form of a restricted Mastercard debit card.

A variety of nutrition education options will be offered throughout the intervention period and participation will be tracked. The Nutrition education options will include a periodic newsletter to participants that will include nutrition and diabetes prevention and management opportunities available through Griffin Hospital Population Health Team, the local health department, program and education opportunities available through the Registered Dietitians, local offerings by SNAP-Education and The Expanded Food and Nutrition Education Program.
No Intervention: Delayed Intervention Group
For participants enrolled in the delayed control group they will complete all the biometric measurements and surveys during the 9-month period while the intervention group received the 6-month intervention and completes the 3-month post intervention assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Change from Baseline at 6 months and 9 months
Glycated hemoglobin A1c (HbA1c) will be collected by Griffin's Community Health RN or Yale-Griffin Prevention Research Center Staff (will be obtained by direct measurements from the participants' finger stick blood sample) at baseline, 6 months and 9 months for both groups, while the intervention group is participating in the intervention and while the delayed group. HbA1c will be used to measure the average plasma glucose concentration and will be measured using a finger-prick test.
Change from Baseline at 6 months and 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diet quality
Time Frame: Change from Baseline at 6 months and 9 months
Diet quality will be measured using the Global Diet Quality Projects Diet Quality Questionnaire (DQQ) the survey can be found here (https://drive.google.com/drive/folders/16rpv-sr05HXTs3NSZmvFbRaL6dFfcuAs,
Change from Baseline at 6 months and 9 months
Food Insecurity
Time Frame: Change from Baseline at 6 months and 9 months
Food insecurity will be assessed using the U.S. Department of Agriculture (USDA) household food security survey module 18-item survey modified for a 30 days time reference point instead of the standard past 12-months.27
Change from Baseline at 6 months and 9 months
Respect and Dignity Scale
Time Frame: Change from Baseline at 6 months and 9 months
This survey, developed with community input from the PRCs CAG and PPR participants in other US projects, will be used to assess participant experiences related to respect and dignity when participating in the various program components.
Change from Baseline at 6 months and 9 months
Body weight
Time Frame: Change from Baseline at 6 months and 9 months
Body weight will be measured using a calibrated Tanita electronic scale.
Change from Baseline at 6 months and 9 months
Blood Pressure
Time Frame: Change from Baseline at 6 months and 9 months
Blood pressure will be measured by using a Dinamap Monitor Pro 100 (GE Healthcare, Piscataway, NJ) after sitting for 5 minutes by a registered nurse.
Change from Baseline at 6 months and 9 months
Serum lipids
Time Frame: Change from Baseline at 6 months and 9 months
Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by direct measurements from the participants' finger stick blood sample. Serum low-density lipoprotein (LDL) will be calculated using the following formula LDL = Tchol - (TG/5 + HDL). HDL:Tchol ratio will also be computed.
Change from Baseline at 6 months and 9 months
Socio-demographics
Time Frame: Change from Baseline at 6 months and 9 months
Socio-demographics will be measured using standard questionnaires developed by the funder and internally developed items.
Change from Baseline at 6 months and 9 months
Health related quality of life
Time Frame: Change from Baseline at 6 months and 9 months
Health related quality of life will be measured using a single item consistent with the CDC Behavioral Risk Factor Surveillance System.28 plus additional items collect self-reported diagnosis of nutrition-related nutrition disease.
Change from Baseline at 6 months and 9 months
Participation in SNAP, food assistance
Time Frame: Change from Baseline at 6 months and 9 months
Participation in SNAP, food assistance will be measured using items standard to the funder,
Change from Baseline at 6 months and 9 months
Nutrition knowledge
Time Frame: Change from Baseline at 6 months and 9 months
Nutrition knowledge will be measured using an internally developed survey based on the Dietary Guidelines for Americans and MyPlate.
Change from Baseline at 6 months and 9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tracking Study Participation Inputs
Time Frame: Change from Baseline at 6 months and 9 months

Data will be collected and monitored related to compliance with voucher spending and seeking tech support related to reloads/utilization of the debit card. Additionally, participation and attendance in nutrition education opportunities will be recorded to understand intervention fidelity.

Field notes: the study core team will have access to a field note data collection survey in Qualtrics. This survey will be a single, open-ended survey question designed to collect contextual information or anecdotes that will help the study team later contextualize findings.

Additionally, investigators plan to use a provider satisfaction survey to assess healthcare providers and those affiliated with the medical practices. This tool was developed internally, and feedback was provided from the team.
Change from Baseline at 6 months and 9 months
Medication use
Time Frame: Change from Baseline at 6 months and 9 months
Medication use during the study will be collected by the study coordinator from the electronic medical record. A medication log will be completed by participants and reviewed with the study coordinator at each assessment time point. This information will also be confirmed with the participant's physician/or by electronic data review.
Change from Baseline at 6 months and 9 months
Emergency room visits
Time Frame: Change from Baseline at 6 months and 9 months
Emergency Department visits and/or hospitalizations will be confirmed via the hospital's Population Health Department project staff.
Change from Baseline at 6 months and 9 months
Hospitalizations
Time Frame: Change from Baseline at 6 months and 9 months
Hospitalizations will be confirmed via the hospital's Population Health Department project staff.
Change from Baseline at 6 months and 9 months
Field notes
Time Frame: Change from Baseline at 6 months and 9 months
The study core team will have access to a field note data collection survey in Qualtrics. This survey will be a single, open-ended survey question designed to collect contextual information or anecdotes that will help the study team later contextualize findings.
Change from Baseline at 6 months and 9 months
Provider satisfaction survey
Time Frame: 9 months
A provider satisfaction survey to assess healthcare providers and those affiliated with the medical practices. This tool was developed internally, and feedback was provided from the team.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Griffin Hospital

Collaborators

Griffin Faculty Physicians
About Fresh

Investigators

  • Study Director: Monica Oris, RN, MSHA, CCM, Griffin Hospital
  • Study Director: Beth P Comerford, MS, Yale-Griffin Prevention Research Center
  • Principal Investigator: Jaime S Foster, PhD, Yale-Griffin Prevention Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

DMP implementation and fidelity will reside with responsibility will reside with the Assistant Director, Evaluation/Data Director, with reporting to the Project Director and co-Investigators. The Yale-Griffin Prevention Research Center handles all data and data management and plans for all its research studies; the Center has established infrastructure to manage all aspects of the data management plan. The DMP implementation will be included in annual and final reports to NIFA and include progress in data sharing (publications, database, software, curriculum, outreach materials, etc.). The final report will also describe the data produced during the award period and the components that will be stored and preserved.

IPD Sharing Time Frame

Baseline, 6 months, 12 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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