Culturally tailored food bundles and nutrition support for adults with food insecurity and diabetes
Culturally Tailored Program for Food-Insecure Adults With Type 2 Diabetes: The SPICE-D Study (Support for People Through Inclusive Cultural Eating for Diabetes)
This program will try culturally familiar food bundles and easy recipes to help adults with type 2 diabetes who have trouble affording healthy food.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT07361341 on ClinicalTrials.gov |
What this trial studies
This pilot hybrid study combines retrospective chart review with a prospective intervention and follow-up to examine the effects of culturally tailored food bundles and literacy-appropriate nutrition materials among predominantly Hispanic, low-income patients at a community clinic. Participants receive three months of culturally familiar food bundles, recipes, and cooking guides, with baseline data from charts and surveys plus follow-up surveys at 3 and 6 months. Outcomes include changes in HbA1c, blood pressure, body mass index, healthcare utilization, and qualitative feedback about food choices and diabetes self-management. The goal is to identify community-centered nutritional strategies that address structural and cultural barriers to healthy eating in uninsured patients served by the clinic.
Who should consider this trial
Good fit: Adults aged 18 or older who are active patients of the Community Care Clinic, meet the clinic's uninsured and low-income eligibility, have documented food insecurity screening and a diagnosis of type 2 diabetes or prediabetes, and live in the clinic's service area are ideal candidates.
Not a fit: People who are food-secure, already have stable diabetes control, or have medical conditions that prevent dietary changes may be unlikely to benefit from this food-bundle intervention.
Why it matters
Potential benefit: If successful, the intervention could improve diet, self-management, and metabolic control for food-insecure adults with diabetes and help reduce local health disparities.
How similar studies have performed: Previous food-support and medically tailored meal programs have produced improvements in diet quality and some metabolic measures, but culturally tailored interventions for low-income Hispanic communities are less extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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% * Reside within designated pickup/delivery zones for food bundle distribution (primary zip codes: 27101, 27105, 27107, and adjacent service areas) * Able and willing to provide written informed consent (available in English and Spanish) * Able to participate in baseline and follow-up assessments either in English or Spanish (the two primary languages at CCC) Exclusion Criteria: * 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) * Type 1 diabetes (ICD-10: E10.x) - requires different dietary management; End-stage renal disease requiring dialysis (special dietary restrictions); Active eating disorder diagnosis; Severe food allergies that would limit ability to safely consume food bundle contents; Recent bariatric surgery (\<12 months) * Documented cognitive impairment or intellectual disability that would impair ability to provide informed consent or participate meaningfully in intervention without caregiver support * Currently enrolled in other intensive nutrition intervention studies or food prescription programs that would confound assessment of the intervention's independent effects * Primary language other than English or Spanish * Plans to move outside of CCC's service area or discontinue care at CCC within the 6-month study period * Physical disabilities, literacy barriers, or other factors that would prevent completion of baseline or follow-up survey instruments, unless accommodations can be reasonably made
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Megan B Irby, PhD — Wake Forest University Health Sciences
- Study coordinator: Megan B Irby, PhD
- Email: irbym@wfu.edu
- Phone: 336.758.4642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.