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Completed

NCT Number: NCT06401668

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

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.

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford HealthCare/ St. Vincent Medical Center

Hartford, Connecticut, 06102, United States

About this study

This study will have a small pilot followed by a randomized controlled trial. The focus of this registration is the randomized controlled trial.

First, following community co-design of the CHW strategy, investigators will conduct a two-month pilot study with an anticipated 10 participants to test the CHW strategy, the produce prescription program Rx, and overall study procedures. All participants will receive the PRx program with CHW strategy for two months.

Second, a randomized controlled trial to evaluate the effectiveness of the CHW strategy on barriers to PRx uptake, level of PRx engagement, and short-term program, behavioral, and health outcomes will be conducted.

Investigators hypothesize that participants who receive added CHW support during their enrollment in the PRx program will have reduced barriers to PRx uptake, higher PRx uptake, and greater improvements in the defined short-term program outcomes compared with participants who do not receive the CHW support during their enrollment in the PRx.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Participants who are pregnant will be eligible for the study if they meet all of the inclusion criteria and do not have any of the exclusion criteria, as the study activities (additional funds to purchase fruits and vegetables, nutrition education, and support from a Community Health Worker) does not pose any additional risk to this group.

Treatment and study plan

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 Program

Behavioral

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

Primary outcomes

  1. PRx redemption

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

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

Secondary outcomes

  1. Barriers to PRx uptake

    Time frame: 3 months, 6 months

    Barriers to PRx uptake will be captured through post-program survey questions on participant barriers to buying and consuming produce as well as from listening sessions and CHW process tracking data on participant encounters.

  2. PRx uptake: Initiation

    Time frame: 6 months

    PRx initiation defined as the number of participants initiating use of the debit card/number enrolled

  3. PRx uptake: Usage

    Time frame: 6 months

    • Months used (defined as #/% participants using any incentives each month for 6mo and % using incentives every month)

  4. PRx uptake: Attendance

    Time frame: 6 months

    Nutrition class attendance defined as a yes/no variable for each of the three classes.

  5. Program Satisfaction

    Time frame: 6 months

    Assessed through listening sessions and a short satisfaction module, coded on a five-point Likert scale in the post survey. Total score range from 0-4 with higher scores indicating greater satisfaction.

  6. Change in Fruit and Vegetable Intake

    Time frame: baseline, 3 months, and 6 months

    Assessed with the 29-item Diet Quality Questionnaire. The 5-minute module asks yes/no questions about consumption of a series of sentinel foods that correspond to pre-defined food groups. It has a total score of 0-10. The higher the score, the higher the likelihood of nutrient adequacy.

  7. Change in Household Food Insecurity

    Time frame: baseline, 3 months, and 6 months

    Assessed using the 6-item US Department of Agriculture Household Food Security Survey Module. The total score range from 0 to 27, with higher scores indicating more food security.

  8. Change in Glycemic control

    Time frame: baseline and 6 months

    Assessed with HbA1c concentration (%) data from patient electronic medical records. A decrease in HbA1c concentration indicates better glycemic control.

  9. Change in Self-rated Health

    Time frame: baseline, 3 months, and 6 months

    Assessed with a single question with a five-item response scale from poor to excellent.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 7, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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