Screening and Nutrition for Patients With Diabetes: A Pilot Study

Villanova University

Status: Enrolling

Conditions: Diabetes Mellitus

Treatments: Behavioral: DSMES Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05674110

IRB-FY2022-228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 and older
• Existing and/or new diagnosis of T2DM
• Food pantry participants
• English and/or Spanish speaking
• Willing/able to provide informed consent
• Must have a mobile device able to receive text messages

Exclusion criteria

• Under the Age of 18
• No T2DM or do not meet HbA1c > 6.5 criteria
• Not a food pantry participant
• Unwilling/unable to provide informed consent
• Spoken language is other than English/Spanish
• Individuals who do not have access to a mobile device or are unable to receive text messages

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Education and Support

Experimental group

Description:

online education and support meetings

Treatment:

Behavioral: DSMES Intervention