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

NCT05939349 | Unknown

• 1 other identifier: 2022-06
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  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 Outcomes (10)

• Diet quality

  Change from Baseline at 6 months and 9 months

• Food Insecurity

  Change from Baseline at 6 months and 9 months

• Respect and Dignity Scale

  Change from Baseline at 6 months and 9 months

• Body weight

  Change from Baseline at 6 months and 9 months

• Blood Pressure

  Change from Baseline at 6 months and 9 months

Other Outcomes (6)

• Tracking Study Participation Inputs

  Change from Baseline at 6 months and 9 months

• Medication use

  Change from Baseline at 6 months and 9 months

• Emergency room visits

  Change from Baseline at 6 months and 9 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

The PPR intervention will span 6 months and will include 2 main components: produce vouchers and nutrition education.

Other: Produce Prescription Group

Delayed Intervention Group

NO INTERVENTION

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.

Interventions

Produce Prescription Group OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Griffin Hospital: lead
• Griffin Faculty Physicians: collaborator
• About Fresh: collaborator

Related Publications (29)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Monica Oris, RN, MSHA, CCM

  Griffin Hospital

  STUDY DIRECTOR

• Beth P Comerford, MS

  Yale-Griffin Prevention Research Center

  STUDY DIRECTOR

• Jaime S Foster, PhD

  Yale-Griffin Prevention Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rockiy G Ayettey, MS, DHSc

CONTACT

2037321125; rockiy.ayettey@yalegriffinprc.org

Summaya Multany, MBBS

CONTACT

2037321325; summaya.multany@yalegriffinprc.org

Study Design

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

Model Details: The eligible participants will be allocated to one of two arms (i.e., the intervention and delayed intervention groups) and assigned a study number using a SAS-generated random table. The participants will be block randomized in blocks of 4, 6, 8, 10, 12 using a permuted block design in a 1:1 ratio to ensure a balance between the intervention and delayed intervention groups.

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: July 11, 2023
• Study Start: September 1, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Baseline, 6 months, 12 months