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Screening and Nutrition for Patients With Diabetes: A Pilot Study

Primary Purpose

Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSMES Intervention
Sponsored by
Villanova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus focused on measuring Food Insecurity, Community Based Participatory Research, Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Villanova UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Education and Support

Arm Description

online education and support meetings

Outcomes

Primary Outcome Measures

Change in Diabetes knowledge
The Diabetes Knowledge Test (DKT2) will test change in diabetes knowledge (measured at baseline and post-intervention completion).

Secondary Outcome Measures

Change in Diabetes Self-Efficacy
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).
Change in eating behaviors
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
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.

Full Information

First Posted
December 9, 2022
Last Updated
May 24, 2023
Sponsor
Villanova University
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1. Study Identification

Unique Protocol Identification Number
NCT05674110
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Villanova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Food Insecurity, Community Based Participatory Research, Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Education and Support
Arm Type
Experimental
Arm Description
online education and support meetings
Intervention Type
Behavioral
Intervention Name(s)
DSMES Intervention
Intervention Description
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 Information:
Title
Change in Diabetes knowledge
Description
The Diabetes Knowledge Test (DKT2) will test change in diabetes knowledge (measured at baseline and post-intervention completion).
Time Frame
Baseline and three months
Secondary Outcome Measure Information:
Title
Change in Diabetes Self-Efficacy
Description
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).
Time Frame
Baseline and three months
Title
Change in eating behaviors
Description
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).
Time Frame
Baseline and three months
Title
Change in Hemoglobin A1c
Description
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.
Time Frame
Baseline and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina R Whitehouse
Phone
610-519-6833
Email
christina.whitehouse@villanova.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina R Whitehouse
Organizational Affiliation
Villanova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Villanova University
City
Villanova
State/Province
Pennsylvania
ZIP/Postal Code
19085
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina R Whitehouse
Phone
610-519-6833
Email
christina.whitehouse@villanova.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Screening and Nutrition for Patients With Diabetes: A Pilot Study

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