An interventional study of Food Bundle Intervention in Type 2 Diabetes Mellitus (T2D), sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 25 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Food Bundle Intervention
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.
Hemoglobin A1c
HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.
Time frame: Baseline
Hemoglobin A1c
HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.
Time frame: Month 3
Hemoglobin A1c
HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6
Body Mass Index
Body Mass Index will be assessed from height and weight data in the electronic medical record.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, 3 months, 6 months
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.
Time frame: up to 12 months
Plan to share: No
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Wake Forest University Health Sciences