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

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401668
• Other study ID #: 2000037606
• Secondary ID: 24FIM1264456
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Rafael Pérez-Escamilla, PhD
• Phone: (203) 737-5882
• Email: rafael.perez-escamilla[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Hartford HealthCare/ St. Vincent Medical Center	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRx redemption	PRx redemption is defined as produce debit card dollars used/total dollars available will be collected from the produce debit card platform.	Monthly, beginning 1 month after the study start though the end of the six month study period.
Secondary	Barriers to PRx uptake	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.	3 months, 6 months
Secondary	PRx uptake: Initiation	PRx initiation defined as the number of participants initiating use of the debit card/number enrolled	6 months
Secondary	PRx uptake: Usage	• Months used (defined as #/% participants using any incentives each month for 6mo and % using incentives every month)	6 months
Secondary	PRx uptake: Attendance	Nutrition class attendance defined as a yes/no variable for each of the three classes.	6 months
Secondary	Program Satisfaction	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 months
Secondary	Change in Fruit and Vegetable Intake	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.	baseline, 3 months, and 6 months
Secondary	Change in Household Food Insecurity	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.	baseline, 3 months, and 6 months
Secondary	Change in Glycemic control	Assessed with HbA1c concentration (%) data from patient electronic medical records. A decrease in HbA1c concentration indicates better glycemic control.	baseline and 6 months
Secondary	Change in Self-rated Health	Assessed with a single question with a five-item response scale from poor to excellent.	baseline, 3 months, and 6 months