Screening and Nutrition for Patients With Diabetes: A Pilot Study

Sponsor
Villanova University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05674110
Collaborator
(none)
20
1
1
5.7
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: DSMES Intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Screening, Education, and Nutrition to Address Diabetes and Food Insecurity for Individuals at a Food Pantry
Anticipated Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Education and Support

online education and support meetings

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. 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).

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Villanova University Villanova Pennsylvania United States 19085

Sponsors and Collaborators

  • Villanova University

Investigators

  • Principal Investigator: Christina R Whitehouse, Villanova University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Villanova University
ClinicalTrials.gov Identifier:
NCT05674110
Other Study ID Numbers:
  • IRB-FY2022-228
First Posted:
Jan 6, 2023
Last Update Posted:
Jan 6, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Villanova University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2023