Clinical trial NCT05674110: Screening and Nutrition for Patients With Diabetes: A Pilot Study
Official title: Screening, Education, and Nutrition to Address Diabetes and Food Insecurity for Individuals at a Food Pantry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Food Insecurity
Community Based Participatory Research
Education
Lead sponsor: Villanova University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Diabetes knowledge
timeFrame: Baseline and three months
Secondary outcomes:
measure: Change in Diabetes Self-Efficacy
timeFrame: Baseline and three months
measure: Change in eating behaviors
timeFrame: Baseline and three months
measure: Change in Hemoglobin A1c
timeFrame: Baseline and six months
Other outcomes:
Locations:
city: Villanova
country: United States
facility: Villanova University
state: Pennsylvania
Study officials:
affiliation: Villanova University
name: Christina R Whitehouse
role: PRINCIPAL_INVESTIGATOR
References: