NCT05674110

Screening and Nutrition for Patients With Diabetes: A Pilot Study

Screening, Education, and Nutrition to Address Diabetes and Food Insecurity for Individuals at a Food Pantry

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Villanova University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this project is to provide diabetes self-management education and support (DSMES) and simultaneously address food insecurity for a high-risk, ethnically diverse adult population who participate in a food pantry. This project will utilize a Community-Based Participatory Research model (CBPR). Community representatives will engage in project implementation by participating in designing the messaging for cultural impact and advising in study operations. This intervention targets food pantry clients self-reporting a T2DM diagnosis or who screen positive for T2DM through on-site HbA1c testing. Once enrolled, participants will complete self-paced web-based/mobile DSMES modules, available in English and Spanish, that include the ADCES7 (Association of Diabetes Care and Education Specialists) Self-Care BehaviorsTM. Support through text messaging, monthly group sessions, and peer mentorship will be facilitated by nursing students, registered dietitian nutritionists (RDNs), and diabetes care and education specialists (DCES) for 12 weeks. Participants will receive nutritious food from the pantry consistent with dietary guidelines for diabetes.

Detailed description

Eligible patients who agree to participate in the study will be screened for diabetes via HbA1c fingerstick measurement. Participants will receive diabetes self-management education, food items recommended by registered dietitians, peer support, monthly in-person group support sessions held at the foot pantry, and text messaging with continued education. Data will be collected at intake. Follow up data will be collected 90 days after enrollment.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	DSMES Intervention	This study will provide participants with on-line education, plus weekly text messaging that will contain messages of support or encouragement sent to participants in the individual's preferred language (English or Spanish). Participants will be encouraged to attend monthly group support meetings to review the content and address any questions. Group meetings will occur at 3-time intervals (end of months: 1, 2, and 3). Group support meetings will be held in-person at a food pantry and moderated by peer mentors, nursing students, registered dietitian nutritionist (RDN), and/or a diabetes care and education specialist (DCES). Group support meetings will be held in Spanish and/or English, with no more than 10 participants in a group at one time, and will last approximately 50 minutes. For the duration of the study, participants will continue to receive monthly food items from the food pantry.

Timeline

• Start date: 2023-01-09
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2023-01-06
• Last updated: 2024-05-14

Locations

1 site across 1 country: United States