Food Bundle Intervention for Diabetes
(SPICE-D Trial)
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment
Participants complete an initial interview and survey about their food security, health challenges, and social needs
Intervention
Participants receive culturally appropriate food bundles and educational materials over a three-month period
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
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
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Citations
A 12-Month Single-Arm, Pre–Post Intervention Study
Low-carbohydrate dietary approaches can lead to improvements in blood glucose levels and weight loss, as well as a reduction and/or ...
a cluster randomised controlled trial in Nepal
A small proportion of the individuals of the RCT reverted to normoglycaemic status, but the intervention seemed to reduce HbA1c and weight ...
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
The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along ...
Food Bank–Based Diabetes Prevention Intervention to ...
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)
The goal of this pilot intervention study is to learn if culturally appropriate food bundles and nutrition education can help people with diabetes who ...
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 ...
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