Screening and Nutrition for Patients With Diabetes: A Pilot Study

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674110
• Other study ID #: IRB-FY2022-228
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2024
• Source: Villanova University
• Contact: Christina R Whitehouse
• Phone: 610-519-6833
• Email: christina.whitehouse[@]villanova.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Villanova University	Villanova	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Villanova University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diabetes knowledge	The Diabetes Knowledge Test (DKT2) will test change in diabetes knowledge (measured at baseline and post-intervention completion).	Baseline and three months
Secondary	Change in Diabetes Self-Efficacy	Change in Diabetes self-efficacy will be measured with the Diabetes Self-Efficacy Scale which will measure individuals' perception of their ability to manage their diabetes (measured at baseline and post intervention completion).	Baseline and three months
Secondary	Change in eating behaviors	Change in eating behaviors will be measured with the Food Frequency Questionnaire (FFQ) and 3 day dietary recall at 3 months (measured at baseline and post-intervention completion).	Baseline and three months
Secondary	Change in Hemoglobin A1c	All participants will provide a fingerstick blood sample collected at 3-months following completing of the intervention. A1C is a measure of glycemic control over the last 3 months.	Baseline and six months