Type 2 Diabetes (T2D) Clinical Trials

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Culturally Tailored Program for Food-Insecure Adults With Type 2 Diabetes: The SPICE-D Study (Support for People Through Inclusive Cultural Eating for Diabetes)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
North Carolina
Wake Forest University Health Sciences
RECRUITING
Winston-salem
Contact Information
Primary
Megan B Irby, PhD
irbym@wfu.edu
336.758.4642
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 25
Treatments
Experimental: Food Bundles
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
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov