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Culturally Tailored Food Program for Type 2 Diabetes (SPICE-D)

This study, called SPICE-D, is looking at whether providing culturally appropriate food and nutrition education can help adults with Type 2 Diabetes (T2D) who have trouble affording healthy food. Participants will receive "Food Bundle Intervention" which includes Hispanic-friendly ingredients, recipes, and cooking guides. The main goal is to see if this program can improve how people cook and eat, increase their nutrition knowledge, and ultimately help them manage their diabetes better. Researchers will measure your Hemoglobin A1c (a blood test that shows average blood sugar levels) at the start, at 3 months, and at 6 months to see if the program is effective. This study is for adults aged 18 and older who are active patients at the Community Care Clinic (CCC) in Winston-Salem, NC. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 25 participants. It is not specified if it is randomized or blinded.
What's involved
You will complete an initial interview and survey. You will receive culturally tailored food bundles and recipe resources over a three-month period.
Compensation
Not stated in the trial record.
Follow-up
Your Hemoglobin A1c will be measured at 3 months and 6 months after the start of the study.

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NCT07361341

Culturally Tailored Program for Food-Insecure Adults: SPICE-D

Recruiting
NAAges 18+InterventionalSupportive care
Wake Forest University Health Sciences
~25 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Food Bundle Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hemoglobin A1c
Measured over Baseline
+5 more outcomes measured

Conditions

Type 2 Diabetes Mellitus (T2D)

Explore related trials

PrediabetesType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Megan B Irby, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Megan B Irby, PhD
[email protected]
336.758.4642
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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%
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

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

What this trial measures

  • Hemoglobin A1cBaseline

    HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.

  • Hemoglobin A1cMonth 3

    HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.

  • Hemoglobin A1cMonth 6

    HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.

  • Self-efficacy in diabetes managementBaseline

    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.

  • Self-efficacy in diabetes managementMonth 3

    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.

  • Self-efficacy in diabetes managementMonth 6

    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.