Nutrition Education + Food Resources for Type 2 Diabetes

(OKCICWCIE+ Trial)

Overseen By Sarah A Stotz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Disqualifiers: Planned move

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining nutrition education with food resources can help American Indian and Alaska Native adults better manage type 2 diabetes. It examines how learning about diabetes-friendly foods through Diabetes Nutrition Education Classes and receiving resources like farmers market vouchers for fresh produce, known as the Healthy Food Security Resource, might enhance food security and health. Participants will be divided into three groups: one receiving both education and food resources, another receiving only education, and the last receiving only food resources. The trial seeks American Indian or Alaska Native adults with type 2 diabetes who speak English. As an unphased trial, this study provides a unique opportunity to contribute to understanding how nutrition education and resources can improve diabetes management.

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 nutrition and food resources, so it's likely you can continue your medications, but please confirm with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that diabetes nutrition education is generally safe for people with type 2 diabetes. Studies indicate that participating in these programs can better control blood sugar levels, with an average A1C level drop—a key blood sugar measure—of about 0.45% to 0.57% compared to regular care. This demonstrates that the education is not only safe but also beneficial for managing diabetes.

Similarly, providing resources like vouchers for fruits and vegetables is considered safe. Although specific reports of negative effects from these resources are lacking, they aim to improve access to healthy foods, which can aid in better diabetes management. People with access to better nutrition often see improvements in their diabetes health.

In summary, both diabetes nutrition education and food security resources have been shown to be safe and can positively impact managing type 2 diabetes. No significant reports of harm exist, making them promising options for those looking to improve their diabetes care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for type 2 diabetes because they focus on lifestyle changes rather than medication. Unlike standard care, which often involves medication like metformin or insulin, these treatments emphasize nutrition education and food security. The "What Can I Eat?" classes offer practical, in-person guidance on managing diabetes through diet, which can empower patients with knowledge and skills. Meanwhile, providing a weekly $30 healthy food resource aims to directly address food security, helping patients access nutritious options consistently. This holistic approach could lead to sustainable lifestyle changes that improve diabetes management without relying solely on medications.

What evidence suggests that this trial's treatments could be effective for managing type 2 diabetes?

Research has shown that learning about nutrition can greatly help people with type 2 diabetes. It can lead to better blood sugar levels and increase patients' understanding and confidence in managing their condition. One study found that people who received this education had a significant improvement in their HbA1c, a measure of blood sugar control. In this trial, participants in one arm will receive both diabetes nutrition education classes and healthy food resources. Another arm will provide only the nutrition education classes, while a separate arm will offer only the healthy food resources. Providing resources like healthy food vouchers can help manage diabetes by addressing food insecurity, which is linked to poorer diabetes control. Offering food resources enables people to develop healthier eating habits and better manage their diabetes. Combining nutrition education with food support could effectively assist those with type 2 diabetes. ^{2 5 6 7 8}

Who Is on the Research Team?

Sarah Stotz, PhD

Principal Investigator

Colorado State University

Are You a Good Fit for This Trial?

This trial is for American Indian and Alaska Native adults who have type 2 diabetes, can speak English fluently, and plan to stay in the area during the study. It's not for those who might move away during the trial period.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

American Indian or Alaska Native

Fluency in English

Exclusion Criteria

Planned move within the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are enrolled in a 3-month intervention with diabetes nutrition education and/or food security resources

12 weeks

5 in-person sessions

Follow-up

Participants are monitored for outcomes such as HbA1c, blood pressure, and food security status

6 months

Data collection at 0, 3, 6, 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Nutrition Education Classes
• Healthy Food Security Resource

Trial Overview

The study tests if diabetes nutrition education classes combined with a food security resource like farmers market vouchers improve diabetes management in AI/ANs. Participants are divided into three groups: one gets both resources, another only education, and the last group just the vouchers.

How Is the Trial Designed?

Group I: What Can I Eat Diabetes Nutrition Education Classes Only Experimental Treatment 1 Intervention

Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 \* 90 min in person classes weekly for a month, with 5th class at 3 months from baseline).

Group II: What Can I Eat Diabetes Nutrition Education Classes + Healthy Food Security Resource Experimental Treatment 2 Interventions

Participants will be enrolled in a 3 month, 5 session in-person diabetes nutrition education class, entitled What Can I Eat?, over the course of the 3 month intervention (4 \* 90 min in person classes weekly for a month, with 5th class at 3 months from baseline). Additionally, patients will receive a $30.00 healthy food resource weekly for 12 weeks.

Group III: Healthy Food Security Resource Only Experimental Treatment 1 Intervention

Patients will receive a $30.00 healthy food resource weekly for 12 weeks.

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Washington State University

Collaborator

Trials

114

Recruited

58,800+

Oklahoma City Indian Clinic

Collaborator

Trials

1

Recruited

70+

Gretchen Swanson Center for Nutrition

Collaborator

Trials

3

Recruited

890+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Published Research Related to This Trial

The activity-based personalized nutrition education (APNE) program significantly improved fasting blood glucose, postprandial blood glucose, and glycated hemoglobin levels in middle-aged and older patients with type 2 diabetes after 3 months, while the control group showed no such improvements.

Participants in the APNE group not only adhered more closely to a balanced diet but also made healthier food choices, such as reducing high-fat food intake and increasing consumption of fruits and vegetables, demonstrating the program's effectiveness in changing dietary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Activity-Based Personalized Nutrition Education on Dietary Behaviors and Blood Parameters in Middle-Aged and Older Type 2 Diabetes Korean Outpatients. Yang, SH., Chung, HK., Lee, SM.[2020]

The paper presents six alternative meal-planning approaches for individuals with diabetes, emphasizing the importance of personalized nutrition education beyond traditional exchange lists.

These approaches, including High Carbohydrate-High Fiber Exchange System and Calorie/Fat Counting, are evaluated based on their effectiveness for weight loss, glucose control, and ease of learning, providing a comprehensive resource for tailored dietary management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternatives to the exchange system for teaching meal planning to persons with diabetes. Pastors, JG.[2017]

A 9-month study involving 33 patients with type 2 diabetes showed that a food education program combined with a supervised exercise regimen significantly improved dietary patterns, including increased intake of healthy fats and vegetables.

The program had a retention rate of 54%, highlighting the importance of strategies to enhance participant attendance and adherence for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a community-based food education programme on dietary pattern in patients with type 2 diabetes: Results of a pilot randomised controlled trial in Portugal. Vasconcelos, C., Cabral, M., Ramos, E., et al.[2021]

A community-based food education program significantly improved nutrition-related knowledge in middle-aged and older patients with type 2 diabetes, as shown by a higher increase in knowledge scores in the experimental group (n=20) compared to the control group (n=16) over a 9-month period.

While the program did not lead to significant changes in knowledge about dietary recommendations and diet-disease relationships, it still encouraged improvements, indicating that such educational interventions can be beneficial for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Community-Based Food Education Program on Nutrition-Related Knowledge in Middle-Aged and Older Patients with Type 2 Diabetes: Results of a Pilot Randomized Controlled Trial. Vasconcelos, C., Almeida, A., Cabral, M., et al.[2020]

Effective nutrition education for adults involves a structured three-phase approach: assessment, intervention, and evaluation, which is crucial for addressing various health issues like weight reduction and diabetes.

Maintaining behavioral changes post-education is a significant challenge, highlighting the need for well-trained nutrition education providers and effective strategies to support long-term adherence to dietary recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition education for risk factor reduction and patient education: a review. Glanz, K.[2019]

A pilot study involving adults with type 2 diabetes and food insecurity showed that a collaboration between a food bank and a health system to deliver tailored food was feasible and led to high participant satisfaction over 24 weeks.

While the intervention improved food security and overall health status, it did not significantly change HbA1c levels or healthcare utilization, suggesting that while food support is beneficial, additional strategies may be needed to improve glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Collaborative Pilot to Support Patients With Diabetes Through Tailored Food Box Home Delivery. Kempainen, S., Cutts, DB., Robinson-O'Brien, R., et al.[2023]

In a study involving 78 type II diabetic outpatients, both nutrition education programs led to significant improvements in dietary goals compared to a control group, indicating their effectiveness in managing diabetes through dietary changes.

However, the addition of a social learning component did not provide any additional benefits over the standard nutrition education program, and there were minimal differences in long-term outcomes like weight or blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition education and social learning interventions for type II diabetes. Glasgow, RE., Toobert, DJ., Mitchell, DL., et al.[2019]

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In conclusion, this study adds to the existing scientific evidence of the benefits of a nutrition education program for patients with type 2 diabetes mellitus ...

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Those receiving clinical nutrition education from an RD or from an RD as well as a non-RD had the largest improvements in HbA1c levels (−0.26 and −0.32, ...

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Results. After 22 weeks, HbA1c improved significantly in the intervention group (−1.7%) from the baseline value, compared to the control group (+0.01%) ...

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