Clinical trial NCT06401668: Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes
Official title: Impact of a Community Health Worker Strategy on Produce Prescription Program Uptake Among People With Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Type 2
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2024-05-07
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will include primary and specialty care patients who identify as Hispanic with T2D and low incomes.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PRx redemption
timeFrame: Monthly, beginning 1 month after the study start though the end of the six month study period.
Secondary outcomes:
measure: Barriers to PRx uptake
timeFrame: 3 months, 6 months
measure: PRx uptake: Initiation
timeFrame: 6 months
measure: PRx uptake: Usage
timeFrame: 6 months
measure: PRx uptake: Attendance
timeFrame: 6 months
measure: Program Satisfaction
timeFrame: 6 months
measure: Change in Fruit and Vegetable Intake
timeFrame: baseline, 3 months, and 6 months
measure: Change in Household Food Insecurity
timeFrame: baseline, 3 months, and 6 months
measure: Change in Glycemic control
timeFrame: baseline and 6 months
measure: Change in Self-rated Health
timeFrame: baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford HealthCare/ St. Vincent Medical Center
state: Connecticut
Study officials:
affiliation: Yale School of Public Health
name: Rafael Perez-Escamilla, MD
role: PRINCIPAL_INVESTIGATOR
References: