Other Clinical Trial - Impact of a Community Health Worker Strategy on

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06401668
Study type	Interventional
Source	Yale University
Contact	Rafael Pérez-Escamilla, PhD
Phone	(203) 737-5882
Email	rafael.perez-escamilla@yale.edu
Status	Not yet recruiting
Phase	N/A
Start date	June 2024
Completion date	June 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms