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Screening and Nutrition for Patients With Diabetes: A Pilot Study

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05674110
Enrollment
20
Registered
2023-01-06
Start date
2023-01-09
Completion date
2024-12-15
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Food Insecurity, Community Based Participatory Research, Education

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.

Interventions

BEHAVIORALDSMES 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.

Sponsors

Villanova University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Diabetes knowledgeBaseline and three monthsThe Diabetes Knowledge Test (DKT2) will test change in diabetes knowledge (measured at baseline and post-intervention completion).

Secondary

MeasureTime frameDescription
Change in Diabetes Self-EfficacyBaseline and three monthsChange 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).
Change in eating behaviorsBaseline and three monthsChange 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).
Change in Hemoglobin A1cBaseline and six monthsAll 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.

Countries

United States

Contacts

Primary ContactChristina R Whitehouse
christina.whitehouse@villanova.edu610-519-6833

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026