Recruiting

Nutrition Education

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07361341

Conditions

Type 2 Diabetes Mellitus (T2D)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Food Bundle Intervention

Study Details

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. 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

Type 2 Diabetes Mellitus (T2D)

Study ID

NCT07361341

Start date

Apr 1, 2026

Status verified date

Nov, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

Food Bundle Intervention

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.

Primary outcome measure

  • Hemoglobin A1c [ Time Frame: Baseline ]
  • Hemoglobin A1c [ Time Frame: Month 3 ]
  • Hemoglobin A1c [ Time Frame: Month 6 ]
  • Self-efficacy in diabetes management [ Time Frame: Baseline ]
  • Self-efficacy in diabetes management [ Time Frame: Month 3 ]
  • Self-efficacy in diabetes management [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Megan B Irby, PhD

336.758.4642irbym@wfu.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

May 26, 2026

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-05-26.