Skip to main content
Clinical Trials/NCT05674110
NCT05674110
Recruiting
Not Applicable

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

Villanova University1 site in 1 country20 target enrollmentJanuary 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Villanova University
Enrollment
20
Locations
1
Primary Endpoint
Change in Diabetes knowledge
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 9, 2023
End Date
December 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change in Diabetes knowledge

Time Frame: Baseline and three months

The Diabetes Knowledge Test (DKT2) will test change in diabetes knowledge (measured at baseline and post-intervention completion).

Secondary Outcomes

  • Change in eating behaviors(Baseline and three months)
  • Change in Hemoglobin A1c(Baseline and six months)
  • Change in Diabetes Self-Efficacy(Baseline and three months)

Study Sites (1)

Loading locations...

Similar Trials