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NCT05674110
Screening and Nutrition for Patients With Diabetes: A Pilot Study
Conditions: Diabetes Mellitus
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: Villanova University
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Age 18 and olderExisting and/or new diagnosis of T2DMFood pantry participantsEnglish and/or Spanish speakingWilling/able to provide informed consentMust have a mobile device able to receive text messagesExclusion Criteria:Under the Age of 18No T2DM or do not meet HbA1c > 6.5 criteriaNot a food pantry participantUnwilling/unable to provide informed consentSpoken language is other than English/SpanishIndividuals who do not have access to a mobile device or are unable to receive text messages
Source: ClinicalTrials.gov (NCT05674110). StuddyBuddy aggregates publicly available trial information.