NCT07361341
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Recruiting · Not Applicable · Wake Forest University Health Sciences · registry updated 2026-05-26
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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: 1. Can providing culturally appropriate foods and recipes improve how people cook and prepare meals at home? 2. Can this approach improve people's nutrition knowledge and help them better manage their diabetes? 3. Can this approach improve overall health outcomes for people with diabetes who face food insecurity? Participants will: 1. Complete an initial interview and survey about their food security, health challenges, and social needs 2. Receive culturally appropriate food bundles designed for their community 3. Receive easy-to-use educational materials including recipes and cooking guides that match their reading level 4. Complete follow-up surveys at 3 months and 6 months to track any changes in their cooking habits, nutrition knowledge, diabetes management, and health
Inclusion
- Adults aged ≥18 years at the time of the first clinic visit during the study period; regardless of sex, gender, race, or ethnicity
- Active patients of the Community Care Clinic (CCC) who received at least one clinical encounter between January 1, 2024 and December 31, 2024; with at least one scheduled follow-up appointment during the prospective study period
- Meet CCC's standard eligibility criteria: Uninsured status (no health insurance coverage); Family income ≤250% of the Federal Poverty Level; Resident of Forsyth County, North Carolina, or surrounding service area
- Completed at least one validated food insecurity screening tool during the study period as part of routine clinical care
- Medical record contains at least one documented measurement for any of the primary outcome variables (body mass index, blood pressure, HbA1c, or healthcare utilization metric)
- Documented diagnosis of Type 2 diabetes (ICD-10: E11.x) OR; Pre-diabetes diagnosis (ICD-10: R73.03) with a hemoglobin A1c ≥9.5%
Exclusion
- Unable to speak proficiently in English or Spanish, as this study and the CCC staff are equipped only to provide services in English and Spanish languages.
- Have known food allergies (documented in the electronic medical record and/or self-reported to CCC or study staff) that may preclude participation in the food bundle program inherent to this protocol.
- Have incomplete records. Medical charts with missing or incomplete demographic information (age, gender) that cannot be verified through other sources
- Patients who were pregnant at any point during the study period (due to expected physiological changes in weight, blood pressure, and glucose metabolism that would confound outcome measurements)
- Patients with documented terminal illness or hospice care during the study period, as their health trajectory and care priorities differ fundamentally from the general population
- Transient patients. Patients who received only one-time urgent/emergent care without established continuity of care at CCC (defined as \<2 visits during study period)