Culturally Tailored Program for Food-Insecure Adults: SPICE-D
ConditionType 2 Diabetes Mellitus (T2D)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Food Bundle Intervention
Other interventionCulturally tailored food bundles containing Hispanic-friendly ingredients that support diabetes management, as well as recipe resources and cooking guides designed for various literacy levels.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Food BundlesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Hemoglobin A1c
HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.
Time frame
Baseline2
Hemoglobin A1c
HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.
Time frame
Month 33
Hemoglobin A1c
HbA1c levels will be obtained via the medical record to indicate glycemic control in patients with diabetes.
Time frame
Month 64
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.
Time frame
BaselineSecondary outcomes
1
Body Mass Index
Body Mass Index will be assessed from height and weight data in the electronic medical record.
Time frame
Baseline, 3 months, 6 months2
Patient perceptions of intervention
Qualitative interviews will assess participant perceptions of the intervention, the food received, and thoughts about diabetes management. Each interview will include 20 questions. Information from the interviews will be qualitatively coded to develop themes reflecting participants' collective perceptions.
Time frame
Baseline, 3 months, 6 months3
Diabetes literacy
Diabetes literacy will be assessed via a series of questions adapted from the Diabetes Literacy Scale to gauge participants' knowledge of standard type 2 diabetes information and diabetes related nutrition. The questionnaire includes 15 items scored on a 5 point Likert scale where 1 reflects low literacy and 5 reflects high literacy.
Time frame
Baseline, 3 months, 6 months4
Number of Emergency Department Visits
Data from the electronic medical record will be used to calculate the number of emergency department visits attended for each participant during the previous 3 months. Data will be total numeric counts of emergency department visits.
Time frame
baseline, 3 months, 6 monthsOther outcomes
1
Difference in hemoglobin A1c levels between food-secure and food-insecure groups
Retrospective chart review will be used to determine the difference in hemoglobin A1c of patients who are food-secure and food-insecure.
Time frame
up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov