Recruiting

Nutrition

Sponsor:

Villanova University

Code:

NCT05674110

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DSMES Intervention

Study Details

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.

Conditions

Diabetes Mellitus

Study ID

NCT05674110

Start date

Jan 9, 2023

Status verified date

May, 2024

Completion date

Dec 15, 2024

Anticipated

Primary completion date

Dec 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Education and Support

online education and support meetings

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.

Primary outcome measure

  • Change in Diabetes knowledge [ Time Frame: Baseline and three months ]

Central Contacts and Locations

Central contacts

Locations

Villanova University

Recruiting

Villanova, Pennsylvania, United States, 19085

Contacts

More Information

Sponsor

Villanova University

Last update posted

May 14, 2024

Last verified

May, 2024

Keywords

  • Food Insecurity
  • Community Based Participatory Research
  • Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Villanova University on 2024-05-14.