Food Bundle Intervention for Diabetes

(SPICE-D Trial)

MB
Overseen ByMegan B Irby, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if culturally appropriate food bundles and nutrition education can assist people with diabetes who struggle to afford healthy food. It will investigate whether these resources improve participants' home cooking, enhance their nutrition knowledge, and aid in better diabetes management. The trial seeks participants who are active patients at Community Care Clinic in Winston-Salem, have Type 2 diabetes or pre-diabetes, and experience food insecurity. Participants will receive food bundles and educational materials and complete surveys to track changes in their habits and health over six months. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance support for managing diabetes through nutrition.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing food and nutrition education, so it's likely you can continue your current medications, but you should confirm with the study staff.

What prior data suggests that this food bundle intervention is safe for people with diabetes?

Research shows that providing food packages to people with diabetes has been well-received and can improve their health. Studies have found that culturally appropriate food helps adults with diabetes eat better and feel more secure about their food supply. No major reports of negative effects from these programs have emerged, indicating safety for participants. These programs focus on offering better food choices and education, posing less risk than treatments involving medication.12345

Why are researchers excited about this trial?

Researchers are excited about the Food Bundle Intervention for diabetes because it focuses on addressing food insecurity in patients with type 2 diabetes or pre-diabetes. Unlike traditional treatments that primarily rely on medication and lifestyle changes, this intervention aims to directly improve access to nutritious foods, which could lead to better management of blood sugar levels. By targeting the root cause of unhealthy eating patterns, this approach has the potential to enhance overall treatment outcomes and quality of life for individuals struggling with both diabetes and food insecurity.

What evidence suggests that this food bundle intervention is effective for diabetes?

Research has shown that lifestyle changes, such as learning about diet and nutrition, can significantly help manage type 2 diabetes. Studies have found that these changes can lower the risk of developing diabetes by about 25% and reduce HbA1c levels, which measure blood sugar, by 0.15%. Receiving structured dietary advice from healthcare providers is both practical and effective for managing prediabetes. Low-carbohydrate diets, which focus on reducing sugar intake, can help control blood sugar and support weight loss. This trial will evaluate the Food Bundle Intervention, which provides culturally appropriate food packages and nutrition education, to improve diabetes management and health outcomes for people who struggle to afford food.678910

Who Is on the Research Team?

MB

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)
See 6 more

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
See 9 more

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?

1

Treatment groups

Experimental Treatment

Group I: Food BundlesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

A 12-Month Single-Arm, Pre–Post Intervention Study

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The effectiveness of lifestyle interventions on type 2 diabetes ...

Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 [95% CI 0·61 to 0·91]), and reduced the levels of ...

Articles The effectiveness of lifestyle interventions on type 2 ...

Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 [95% CI 0·61 to 0·91]), and reduced the levels of HbA1c by 0·15% [−0· ...

The effectiveness of a primary care nursing-led dietary ... - PMC

Study findings confirm the feasibility and acceptability of primary care nurses providing structured dietary advice to patients with prediabetes ...

Food Insecurity and Diabetes: Overview of Intersections ... - PMC

Studies show that the provision of produce and/or diabetes-appropriate packages to adults with diabetes results in improved food security, dietary intake, ...

Protocol for the Food as Medicine for Diabetes (FAME-D) trial

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This intervention demonstrated that food banks can effectively screen clients at high risk for diabetes and improve household food security and other risk ...

Food Bundle Intervention for Diabetes (SPICE-D Trial)

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Healthy Food Delivery for Type 2 Diabetes Management in ...

The primary outcome is change in HbA1c, with secondary measures including diet quality (Healthy Eating Index-2015, calculated from one 24-hr dietary recall at ...