Screening and Nutrition for Patients With Diabetes: A Pilot Study

NCT ID: NCT05674110

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2024-12-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Education and Support

online education and support meetings

Group Type: EXPERIMENTAL

DSMES Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Villanova University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina R Whitehouse

Role: PRINCIPAL_INVESTIGATOR

Villanova University

Locations

Villanova University

Villanova, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Christina R Whitehouse

Role: CONTACT

christina.whitehouse@villanova.edu

610-519-6833

Facility Contacts

Christina R Whitehouse

Role: primary

christina.whitehouse@villanova.edu

610-519-6833

Other Identifiers

IRB-FY2022-228

Identifier Type: -

Identifier Source: org_study_id