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

NCT07361341 | Recruiting

• 1 other identifier: IRB00141289
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Can providing culturally appropriate foods and recipes improve how people cook and prepare meals at home?
2. 2.Can this approach improve people's nutrition knowledge and help them better manage their diabetes?
3. 3.Can this approach improve overall health outcomes for people with diabetes who face food insecurity?
4. 4.Complete an initial interview and survey about their food security, health challenges, and social needs
5. 5.Receive culturally appropriate food bundles designed for their community
6. 6.Receive easy-to-use educational materials including recipes and cooking guides that match their reading level
7. 7.Complete follow-up surveys at 3 months and 6 months to track any changes in their cooking habits, nutrition knowledge, diabetes management, and health

Conditions

Type 2 Diabetes Mellitus (T2D)

Keywords

type 2 diabetes mellitus; culture; nutrition; Spanish; food insecurity

Outcome Measures

Primary Outcomes (6)

• Hemoglobin A1c

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

  Baseline

• Hemoglobin A1c

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

  Month 3

• Hemoglobin A1c

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

  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.

  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.

  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.

  Month 6

Secondary Outcomes (6)

• Body Mass Index

  Baseline, 3 months, 6 months

• Patient perceptions of intervention

  Baseline, 3 months, 6 months

• Diabetes literacy

  Baseline, 3 months, 6 months

• Number of Emergency Department Visits

  baseline, 3 months, 6 months

• Number of Missed Appointments

  baseline, 3 months, 6 months

Other Outcomes (1)

• Difference in hemoglobin A1c levels between food-secure and food-insecure groups

  up to 12 months

Study Arms (1)

Food Bundles

EXPERIMENTAL

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

Interventions

Food Bundle Intervention OTHER

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.

Food Bundles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Megan B Irby, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan B Irby, PhD

CONTACT

336.758.4642; irbym@wfu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 23, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)