Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Culturally Tailored Program for Food-Insecure Adults With Type 2 Diabetes: The SPICE-D Study (Support for People Through Inclusive Cultural Eating for Diabetes)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires, Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Complete an initial interview and survey about their food security, health challenges, and social needs 2."
- "Complete follow-up surveys at 3 months and 6 months to track any changes in their cooking habits, nutrition knowledge, diabetes management, and health"
- "Qualitative interviews also will elucidate patient perspectives of their care, their food choices, and their experiences managing diabetes."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This small study tests whether food bundles, recipes, and nutrition lessons that fit people's cultures can improve cooking habits, diabetes care, and health. It is for adults with diabetes or certain prediabetes diagnoses who struggle to afford healthy food and get care at Community Care Clinic in Winston-Salem, North Carolina.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older at your first clinic visit during the study.
- Be an active Community Care Clinic patient with at least one visit in 2024 and a follow-up visit scheduled during the study.
- Have no health insurance, have family income at or below 250% of the federal poverty level, and live in Forsyth County or the clinic's nearby service area.
- Have completed a clinic screening about trouble getting enough food during the study period.
- Have at least one health measure in your record: body mass index (weight compared with height), blood pressure, HbA1c (average blood sugar), or use of health care.
- Have type 2 diabetes, or have prediabetes with an HbA1c of 9.5% or higher.
- Live in a food pickup or delivery area, mainly ZIP codes 27101, 27105, 27107, or nearby service areas.
- Be able and willing to give written consent and complete the first and follow-up study checks in English or Spanish.
Who can't join
- Your main language is not English or Spanish, or you cannot speak either language well enough to take part.
- Have food allergies that could keep you from safely using the food bundles.
- Have missing age or gender information that cannot be checked, or received only one-time urgent or emergency care without ongoing clinic care (fewer than two visits during the study).
- Were pregnant at any time during the study, or had a terminal illness or hospice care during the study.
- Have type 1 diabetes, kidney failure needing dialysis (treatment to filter blood), a current eating disorder, or weight-loss surgery within the past 12 months.
- Have memory, thinking, or learning problems that prevent consent or taking part without caregiver help; or have physical, reading, or other barriers to surveys that cannot reasonably be addressed.
- Are in another intensive nutrition study or food prescription program that could affect the study results.
- Plan to move outside the clinic's service area or stop getting care there within the six-month study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
NC
- Wake Forest University Health Sciences · Winston-Salem, NC 27157Megan B Irby, PhD · Study contactMore trials in Winston-Salem