Nutrition Education + Food Resources for Type 2 Diabetes

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

67 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Healthy nutrition habits are key to managing type 2 diabetes (T2D). However, American Indian and Alaska Natives (AI/ANs) often lack access to culturally relevant nutrition education and they disproportionately experience food insecurity. Food insecurity, defined as lack of consistent access to enough food for an active, healthy life, negatively impacts one's ability to engage in diabetes self-management and care. The purpose of this study is to evaluate if diabetes nutrition education and an added food security resource, such as farmers market vouchers for fruits and vegetables, can improve diabetes self-management for AI/ANs with T2D. Researchers will work with collaborators at the Oklahoma City Indian Clinic in Oklahoma City, OK, and an American Indian community advisory board (CAB) throughout the study to ensure the nutrition education and food security resources are designed to meet the needs of the community and clinic. With the guidance of the CAB, researchers will recruit adults with T2D to participate in a 3-month intervention. Participants will be randomized into one of 3 groups. Some people will have diabetes nutrition education and the food security resource, some will have only the diabetes nutrition education, and some will receive only the food security resource. Outcomes such as food security status and clinical diabetes health indicators will be measured at 5 timepoints. This intervention is significant to diabetes because AI/ANs experience diabetes health disparities and the combination of diabetes nutrition education plus an added food security resource could help decrease T2D complications and improve quality of life for AI/ANs.

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 nutrition education and food resource support safe for people with type 2 diabetes?

Nutrition education and food resource support, such as tailored food delivery and personalized education, have been shown to be safe and well-received by participants with type 2 diabetes, with high levels of satisfaction and no reported safety concerns. ^{1 2 3 4 5}

How does the Nutrition Education + Food Resources treatment for Type 2 Diabetes differ from other treatments?

This treatment is unique because it combines nutrition education classes with access to healthy food resources, focusing on empowering patients to make better dietary choices and improve food security. Unlike standard drug treatments, this approach emphasizes lifestyle changes and education to help manage diabetes more effectively. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Nutrition Education + Food Resources for Type 2 Diabetes?

Research shows that nutrition education can improve dietary habits and increase nutrition-related knowledge in people with type 2 diabetes, which is important for managing the condition. Studies have found that such programs can lead to better dietary patterns, like increased vegetable intake and reduced fat consumption, which are beneficial for diabetes management. ^{7 8 10 11 12}

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Exploring the provision of diabetes nutrition education by practice nurses in primary care settings. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Nutrition education and social learning interventions for type II diabetes. [2019]

3. Switzerland 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. [2020]

4. England 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. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[The nutritional education of patients with diabetes]. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Evaluation of an Internet-Based Diabetes Nutrition Education Resource. [2020]

8. Korea (South) 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. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A Collaborative Pilot to Support Patients With Diabetes Through Tailored Food Box Home Delivery. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

National Diabetes Education Program: opportunities and challenges. The National Diabetes Education Program Strategic Planning Committee. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Nutritional and eating education improves knowledge and practice of patients with type 2 diabetes concerning dietary intake and blood glucose control in an outlying city of China. [2023]