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

Summary

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.

Conditions

• Pre Diabetes
• Diabetes Mellitus, Type 2

Interventions

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.

Sponsors & Collaborators

• Griffin Faculty Physicians

  collaborator UNKNOWN

• About Fresh

  collaborator UNKNOWN

• Griffin Hospital

  lead OTHER

Principal Investigators

• Monica Oris, RN, MSHA, CCM · Griffin Hospital

• Beth P Comerford, MS · Yale-Griffin Prevention Research Center

• Jaime S Foster, PhD · Yale-Griffin Prevention Research Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-01

Primary Completion

2025-08-31

Completion

2025-08-31