Screening and Nutrition for Patients With Diabetes: A Pilot Study
- Conditions
- Diabetes Mellitus
- Interventions
- Behavioral: DSMES Intervention
- Registration Number
- NCT05674110
- Lead Sponsor
- Villanova University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Education and Support DSMES Intervention online education and support meetings
- Primary Outcome Measures
Name Time Method Change in Diabetes knowledge Baseline and three months The Diabetes Knowledge Test (DKT2) will test change in diabetes knowledge (measured at baseline and post-intervention completion).
- Secondary Outcome Measures
Name Time Method Change in eating behaviors Baseline and three months 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).
Change in Hemoglobin A1c Baseline and six months 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.
Change in Diabetes Self-Efficacy Baseline and three months 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).
Trial Locations
- Locations (1)
Villanova University
🇺🇸Villanova, Pennsylvania, United States