Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07361341

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

Led by Wake Forest University Health Sciences · Updated on 2026-04-27

25

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 6518 years at first clinic visit during study
  • Active Community Care Clinic patients with at least one clinical encounter in 2024 and one scheduled follow-up
  • Uninsured with family income 65250% of Federal Poverty Level
  • Resident of Forsyth County, NC or nearby service areas
  • Completed a validated food insecurity screening during study
  • Medical record includes at least one measurement of BMI, blood pressure, HbA1c, or healthcare use
  • Diagnosed with Type 2 diabetes (ICD-10: E11.x) or pre-diabetes (ICD-10: R73.03) with HbA1c 659.5%
  • Live within designated zip codes for food bundle distribution
  • Able and willing to give written informed consent in English or Spanish
  • Able to participate in assessments in English or Spanish
Not Eligible

You will not qualify if you...

  • Unable to speak English or Spanish proficiently
  • Known food allergies preventing participation in food bundle program
  • Incomplete medical records missing age or gender
  • Pregnant during study period
  • Terminal illness or hospice care during study
  • Only received one urgent/emergent care visit without continuity at CCC
  • Type 1 diabetes, end-stage renal disease requiring dialysis, active eating disorder, severe food allergies, recent bariatric surgery (<12 months)
  • Cognitive impairment or intellectual disability preventing consent or participation without support
  • Enrolled in other intensive nutrition or food prescription studies
  • Primary language other than English or Spanish
  • Plans to move away or stop care at CCC within 6 months
  • Physical disabilities, literacy barriers, or other factors preventing survey completion without accommodations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

M

Megan B Irby, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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