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The goal of this pilot intervention study is to learn if culturally appropriate food bundles and nutrition education can help people with diabetes who struggle to afford healthy food in patients with diabetes receiving care at Community Care Clinic in Winston-Salem, NC. The main questions we hope to answer are:
Participants will:
The purpose of this hybrid study is to examine the relationship between food insecurity and health outcomes among predominantly Hispanic, low-income patients at the Community Care Clinic (CCC), and to evaluate the impact of culturally tailored food interventions on diabetes management and overall health. Using retrospective chart review and prospective cohort analysis, this research will assess how food insecurity affects key health indicators including glycemic control (HbA1c), blood pressure, body mass index, and healthcare utilization patterns. Qualitative interviews also will elucidate patient perspectives of their care, their food choices, and their experiences managing diabetes. Through the provision of culturally familiar food bundles and recipe resources over a three-month period, this study aims to identify effective, community-centered nutritional strategies that address both the structural barriers and cultural dimensions of food insecurity in this vulnerable population. The findings will inform evidence-based interventions to improve diabetes care and reduce health disparities among uninsured, low-income patients at the CCC and similar safety-net clinics serving marginalized communities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food Bundles | Experimental | active patients of the Community Care Clinic with diagnosis of Type 2 diabetes or pre-diabetes with an hemoglobin A1c of >/= 9.5% who are food insecure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Bundle Intervention | Other | Culturally tailored food bundles containing Hispanic-friendly ingredients that support diabetes management, as well as recipe resources and cooking guides designed for various literacy levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes. | Baseline |
| Hemoglobin A1c | HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes. | Month 3 |
| Hemoglobin A1c | HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes. | Month 6 |
| Self-efficacy in diabetes management | Self-efficacy in diabetes management will be assessed using questions adapted from the Self Efficacy for Managing Diabetes Scale. The instrument includes 8 questions assessing how secure patients feel in managing their diabetes. Questions include a Likert scale ranging from 1 to 10, where 1 represents low self efficacy and 10 represents high self efficacy. | Baseline |
| Self-efficacy in diabetes management | Self-efficacy in diabetes management will be assessed using questions adapted from the Self Efficacy for Managing Diabetes Scale. The instrument includes 8 questions assessing how secure patients feel in managing their diabetes. Questions include a Likert scale ranging from 1 to 10, where 1 represents low self efficacy and 10 represents high self efficacy. | Month 3 |
| Self-efficacy in diabetes management | Self-efficacy in diabetes management will be assessed using questions adapted from the Self Efficacy for Managing Diabetes Scale. The instrument includes 8 questions assessing how secure patients feel in managing their diabetes. Questions include a Likert scale ranging from 1 to 10, where 1 represents low self efficacy and 10 represents high self efficacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Body Mass Index will be assessed from height and weight data in the electronic medical record. | Baseline, 3 months, 6 months |
| Patient perceptions of intervention | Qualitative interviews will assess participant perceptions of the intervention, the food received, and thoughts about diabetes management. Each interview will include 20 questions. Information from the interviews will be qualitatively coded to develop themes reflecting participants' collective perceptions. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in hemoglobin A1c levels between food-secure and food-insecure groups | Retrospective chart review will be used to determine the difference in hemoglobin A1c of patients who are food-secure and food-insecure. | up to 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan B Irby, PhD | Contact | 336.758.4642 | irbym@wfu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Megan B Irby, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Month 6 |
| Baseline, 3 months, 6 months |
| Diabetes literacy | Diabetes literacy will be assessed via a series of questions adapted from the Diabetes Literacy Scale to gauge participants' knowledge of standard type 2 diabetes information and diabetes related nutrition. The questionnaire includes 15 items scored on a 5 point Likert scale where 1 reflects low literacy and 5 reflects high literacy. | Baseline, 3 months, 6 months |
| Number of Emergency Department Visits | Data from the electronic medical record will be used to calculate the number of emergency department visits attended for each participant during the previous 3 months. Data will be total numeric counts of emergency department visits. | baseline, 3 months, 6 months |
| Number of Missed Appointments | Data from the electronic medical record will be obtained to provide the number of missed medical appointments at the Community Care Clinic for each patient during the previous 3 months. Data will be numeric counts of the total number of missed visits. | baseline, 3 months, 6 months |
| Diastolic and Systolic Blood Pressure (mm/Hg) | Diastolic and Systolic blood pressure (mm/Hg) will be obtained from the electronic medical record for each patient corresponding to the date of their routine medical visit at the Community care Clinic. | baseline, 3 months, 6 months |
| D004700 | Endocrine System Diseases |