Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes
NCT ID: NCT06401668
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
116 participants
INTERVENTIONAL
2025-04-08
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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PRx with the CHW strategy
Participants in this group will have CHWs to offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.
Community health worker (CHW) strategy
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
The PRx Program provides free fruit and vegetables and nutrition education to patients with T2D and food insecurity.
PRx without the CHW strategy
Participants in this group will participate in the PRx without the use of CHWs
PRx Program
The PRx Program provides free fruit and vegetables and nutrition education to patients with T2D and food insecurity.
Interventions
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Community health worker (CHW) strategy
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
The PRx Program provides free fruit and vegetables and nutrition education to patients with T2D and food insecurity.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Rafael Perez-Escamilla, MD
Role: PRINCIPAL_INVESTIGATOR
Yale School of Public Health
Locations
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Hartford HealthCare/ St. Vincent Medical Center
Hartford, Connecticut, United States
Countries
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Other Identifiers
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24FIM1264456
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2000037606
Identifier Type: -
Identifier Source: org_study_id
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