Screening and Nutrition for Patients With Diabetes: A Pilot Study

NCT05674110 | Recruiting

• 1 other identifier: IRB-FY2022-228
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Food Insecurity; Community Based Participatory Research; Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Diabetes Self-Efficacy

  Baseline and three months

• Change in eating behaviors

  Baseline and three months

• Change in Hemoglobin A1c

  Baseline and six months

Study Arms (1)

Education and Support

EXPERIMENTAL

online education and support meetings

Behavioral: DSMES Intervention

Interventions

DSMES Intervention BEHAVIORAL

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.

Education and Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Villanova University: lead

Study Sites (1)

Villanova University

Villanova, Pennsylvania, 19085, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christina R Whitehouse

  Villanova University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina R Whitehouse

CONTACT

610-519-6833; christina.whitehouse@villanova.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 6, 2023
• Study Start: January 9, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)