Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes
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About
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.
Full description
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.
Enrollment
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Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
116 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Rafael Pérez-Escamilla, PhD; Katherine LaMonaca, MPH
Data sourced from clinicaltrials.gov
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