Food Bundle Intervention for Diabetes

(SPICE-D Trial)

Overseen By Megan B Irby, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Type 1 diabetes, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Megan B Irby, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 or pre-diabetes, uninsured, income ≤250% of the Federal Poverty Level in Forsyth County, NC. They must have a clinic visit between Jan-Dec 2024 and be willing to do surveys. Excludes those outside delivery zones or unable to consent.

Inclusion Criteria

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)

Exclusion Criteria

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)

My primary language is neither English nor Spanish.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants complete an initial interview and survey about their food security, health challenges, and social needs

1 week

1 visit (in-person)

Intervention

Participants receive culturally appropriate food bundles and educational materials over a three-month period

12 weeks

Regular distribution of food bundles

Follow-up

Participants complete follow-up surveys at 3 months and 6 months to track changes in cooking habits, nutrition knowledge, diabetes management, and health

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Food Bundle Intervention

Trial Overview

The SPICE-D study tests if food bundles and nutrition education tailored to cultural needs can improve meal preparation, diabetes management knowledge, and overall health in food-insecure diabetic patients at Community Care Clinic.

How Is the Trial Designed?

Group I: Food Bundles Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+