Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes

NCT06401668 | Active Not Recruiting

• 2 other identifiers: 200003760624FIM1264456
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Produce prescription programs (PRx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (T2D) and food insecurity, but uptake has been suboptimal. There is a critical need for scalable, evidence-based implementation strategies for improving PRx uptake and optimizing the effectiveness and cost-effectiveness of these interventions. This study will co-design and pilot a community health worker (CHW) strategy and test the effectiveness of the strategy compared to PRx participants without a CHW. The overall objective of this study is to test and evaluate a theory-informed, user-centered community health worker (CHW) implementation strategy to improve uptake of a PRx, among Hispanic Medicaid-eligible patients with T2D in Connecticut (CT). CHWs will offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• PRx redemption

  PRx redemption is defined as produce debit card dollars used/total dollars available will be collected from the produce debit card platform.

  Monthly, beginning 1 month after the study start though the end of the six month study period.

Secondary Outcomes (9)

• Barriers to PRx uptake

  3 months, 6 months

• PRx uptake: Initiation

  6 months

• PRx uptake: Usage

  6 months

• PRx uptake: Attendance

  6 months

• Program Satisfaction

  6 months

Study Arms (2)

PRx with the CHW strategy

EXPERIMENTAL

Participants in this group will have CHWs to offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.

Behavioral: Community health worker (CHW) strategy; Behavioral: PRx Program

PRx without the CHW strategy

ACTIVE COMPARATOR

Participants in this group will participate in the PRx without the use of CHWs

Behavioral: PRx Program

Interventions

Community health worker (CHW) strategy BEHAVIORAL

CHWs will offer participants personalized support to assist in overcoming barriers and leveraging facilitators to PRx uptake. CHWs are trained lay members of the communities they serve. The CHW strategy is an evidence-based.

PRx with the CHW strategy

PRx Program BEHAVIORAL

The PRx Program provides free fruit and vegetables and nutrition education to patients with T2D and food insecurity.

PRx with the CHW strategy; PRx without the CHW strategy

Eligibility Criteria

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

You may qualify if:

• Be a current primary or specialty care patient at Hartford Hospital
• Live in Hartford County
• Identify as Hispanic
• Have a current diagnosis of Type II Diabetes
• Be eligible for Medicaid based on household income and size.

You may not qualify if:

• Does not speak English or Spanish
• Has a diagnosis of gestational diabetes
• Individuals who are members of vulnerable populations, such as individuals who are incarcerated and individuals who are not able to consent.

Sponsors & Collaborators

• Yale University: lead
• American Heart Association: collaborator

Study Sites (1)

Hartford HealthCare/ St. Vincent Medical Center

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Rafael Perez-Escamilla, MD

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Eligible participants will include primary and specialty care patients who identify as Hispanic with T2D and low incomes.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 7, 2024
• Study Start: April 8, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)