Nutrition Education for Type 2 Diabetes

Overseen By Laura Kruskall, PhD, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nevada, Las Vegas

Must not be taking: Metformin, Insulin

Disqualifiers: T2DM, Non-English, Cardiovascular, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

120 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial requires that participants are not using medications to control blood glucose, such as Metformin or insulin, so you may need to stop these medications to participate.

What data supports the effectiveness of the treatment Cooking Matters for Adults (CMA) for Type 2 Diabetes?

Research shows that cooking education programs can improve cooking confidence, dietary habits, and health outcomes like blood sugar levels in people with diabetes. For example, a study found that a culinary medicine program led to better blood sugar control and increased fruit and vegetable consumption among participants. ^{1 2 3 4 5}

Is the Nutrition Education for Type 2 Diabetes program safe for humans?

The Cooking Matters for Adults program, which is similar to the Nutrition Education for Type 2 Diabetes program, has been used safely in various groups, including veterans and adults with developmental disabilities, to improve cooking skills and dietary habits without any reported safety concerns. ^{2 6 7 8 9}

How is the Cooking Matters for Adults (CMA+) treatment different from other treatments for type 2 diabetes?

The Cooking Matters for Adults (CMA+) treatment is unique because it focuses on nutrition education and cooking skills to help people with type 2 diabetes make healthier food choices, which can improve their overall health and diabetes management. Unlike traditional treatments that may focus on medication, this program empowers individuals through practical cooking classes and nutrition knowledge, enhancing their ability to manage their condition through diet. ^{2 3 10 11 12}

What is the purpose of this trial?

This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior).

Research Team

Sara K Rosenkranz, PhD

Principal Investigator

University of Nevada, Las Vegas

Eligibility Criteria

This trial is for individuals in Clark County at risk of or diagnosed with prediabetes or type 2 diabetes. Participants should be interested in nutrition education and willing to wear a glucose monitor if assigned to the enhanced group. Specific eligibility details are not provided, but typically include being an adult and meeting certain health conditions.

Inclusion Criteria

I am at a higher risk for type 2 diabetes due to my ethnicity, education, or income.

I am at risk for type 2 diabetes or have been diagnosed with pre-diabetes.

I am at risk for type 2 diabetes based on my family history, weight, or blood sugar levels.

Exclusion Criteria

People who are non-English speaking

People who have dietary restrictions including those following a vegan diet, gluten-free diet, or with food allergies to any fruits or vegetables

My blood pressure is not higher than 140/90.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including finger-sticks for lipids, glucose, and HbA1c%, body composition assessments, and questionnaires

1 week

1 visit (in-person)

Treatment

Participants attend cooking and educational sessions once per week for 6 weeks, with additional components for the CMA+ arm

6 weeks

6 visits (in-person)

Follow-up

Follow-up assessments conducted to evaluate changes in lifestyle practices and barriers to fruit and vegetable consumption

6 weeks

1 visit (in-person), additional follow-up via phone/email/Zoom

Treatment Details

Interventions

• Cooking Matters for Adults (CMA)
• Cooking Matters for Adults (CMA+)

Trial Overview The study tests a standard Cooking Matters for Adults (CMA) curriculum against an enhanced version (CMA+) that includes additional diabetes-related information and the use of continuous glucose monitors. It measures how well these programs help participants eat more fruits and vegetables, manage blood sugar levels, reduce heart disease risk factors, and improve gut health over six weeks.

Participant Groups

Group I: Cooking Matters for Adults (CMA+) Experimental Treatment 1 Intervention

Baseline and Post-test assessments and The CMA curriculum + Enhanced cooking classes with added components comprising cooking practices specific to diabetes prevention, online information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. The CMA+ arm will also have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment visit. This will be an optional component and participants will not be excluded if they do not wish to use the CGM.

Group II: Cooking Matters for Adults (CMA) Active Control 1 Intervention

Arm 1) CMA: 6 didactic sessions delivered once per week for 6 weeks at the UNLV Nutrition Center (in person) Baseline and post-test assessments and 6 cooking classes. * Lesson 1: Let's Get Cooking! * Lesson 2: Choosing Fruits, Vegetables and Whole Grains * Lesson 3: Healthy Starts at Home * Lesson 4: The Power of Planning * Lesson 5: Shopping Smart * Lesson 6: Recipes for Success

Cooking Matters for Adults (CMA+) is already approved in United States for the following indications:

Approved in United States as Cooking Matters for Adults for:

• Type 2 Diabetes Prevention
• Nutrition Education

Who Is Running the Clinical Trial?

University of Nevada, Las Vegas

Lead Sponsor

Trials

81

Recruited

14,700+

University of Nevada, Reno

Collaborator

Trials

34

Recruited

20,200+

Findings from Research

The Expert Patient Programme (EPP) designed for individuals with Type 2 diabetes did not show any significant improvements in glycaemic control or dietary outcomes compared to individual dietitian appointments in a study of 317 adults.

Despite a slight increase in starch intake among the EPP group, the overall results indicate that the EPP approach was ineffective in promoting healthier eating habits or improving diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can peer educators influence healthy eating in people with diabetes? Results of a randomized controlled trial. Cade, JE., Kirk, SF., Nelson, P., et al.[2022]

A 12-week cooking education class for 75 veterans with prediabetes and diabetes led to a significant average weight loss of 2.91 lbs and improved cooking confidence and dietary habits.

The study found no significant differences in weight loss or laboratory results between veterans who attended the class in person and those who participated via Clinical Video Telehealth, suggesting that remote education can be as effective as in-person classes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cooking Education Improves Cooking Confidence and Dietary Habits in Veterans. Dexter, AS., Pope, JF., Erickson, D., et al.[2022]

In a study of 124 adults with type 2 diabetes (T2DM) compared to 124 matched adults without diabetes, those with T2DM had a higher intake of total fat, protein, and lower carbohydrate and fiber, indicating a need for dietary education to improve their nutrient balance.

Despite similar overall energy intake, T2DM individuals consumed more unhealthy saturated fats and less fiber, suggesting that dietary modifications focusing on increasing fiber and healthier fat sources could enhance metabolic control and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High saturated-fat and low-fibre intake: a comparative analysis of nutrient intake in individuals with and without type 2 diabetes. Breen, C., Ryan, M., McNulty, B., et al.[2021]

The A Prescription for Healthy Living (APHL) culinary medicine curriculum led to a significant reduction in HbA1c levels among patients with diabetes, indicating improved blood sugar control, with a mean difference of -0.96% (p = 0.028).

Participants in the APHL program reported increased fruit and vegetable consumption, greater confidence in cooking healthy meals, and more frequent cooking from scratch, suggesting positive changes in dietary behaviors and self-efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. Sharma, SV., McWhorter, JW., Chow, J., et al.[2022]

A multidisciplinary cooking program at a health center significantly improved participants' cooking self-efficacy and diet-related self-management strategies, with 44% reporting increased vegetable consumption after attending the classes.

Participants felt a strong sense of community, with 100% feeling valued in their cooking group, highlighting the program's effectiveness in fostering social connections alongside dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-Sector Partnerships for Improved Cooking Skills, Dietary Behaviors, and Belonging: Findings from a Produce Prescription and Cooking Education Pilot Program at a Federally Qualified Health Center. Ylitalo, KR., Janda, KM., Clavon, R., et al.[2023]

In a study involving 3077 participants at a Community Teaching Kitchen, patients with diabetes who were highly engaged showed a significant reduction in HbA1c levels from 9.8% to 8.6% over 6 months, with sustained improvements for up to 36 months.

Patients with hypertension also experienced significant and sustained reductions in blood pressure, indicating that engagement in culinary education can lead to better management of chronic diseases and improve overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Chronic-Disease Education through Integrated Medical and Social Care: Exploring the Beneficial Role of a Community Teaching Kitchen in Oregon. Tanumihardjo, JP., Davis, H., Zhu, M., et al.[2023]

A pilot cooking-based nutrition education program, Cooking Matters for Adults, showed positive trends in healthy food preparation and balanced diet intake among 8 adults with developmental disabilities and 7 direct support professionals, assessed at post-test and 6 months later.

Participants reported increased confidence in cooking skills and satisfaction with the program, highlighting the effectiveness of a dyad approach that includes both adults with developmental disabilities and their support professionals in learning about healthy eating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better Together: A Pilot Study on Cooking Matters for Adults With Developmental Disabilities and Direct Support Professionals. Barnhart, WR., Havercamp, SM., Lorenz, A., et al.[2020]

In a study of 523 food-insecure adults with diabetes, those who recently utilized diabetes management services reported higher vegetable intake, suggesting that healthcare support can positively influence dietary choices.

However, there was no significant change in fruit or sugar-sweetened beverage consumption related to healthcare utilization, indicating that while some dietary improvements can be made, challenges remain in reducing less healthy food choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes-Related Health Care Utilization and Dietary Intake Among Food Pantry Clients. Bomberg, EM., Rosenmoss, S., Smith, M., et al.[2023]

The Food As Medicine (FAME) initiative successfully engaged children in hands-on cooking and nutrition education, leading to increased enthusiasm for trying new foods and assisting with meal preparation at home.

The pilot program demonstrated that involving children in nutrition education can positively influence family dietary habits, encouraging healthier eating practices among low-income families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food as Medicine: A Pilot Nutrition and Cooking Curriculum for Children of Participants in a Community-Based Culinary Medicine Class. Marshall, H., Albin, J.[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]

In a study of 124 individuals with type 2 diabetes, lower nutrition knowledge was linked to poorer dietary choices, including higher sugar intake and lower consumption of fruits and vegetables, which can negatively affect metabolic management.

The findings suggest that improving nutrition knowledge and skills through education could lead to better dietary self-management in individuals with type 2 diabetes, potentially enhancing their overall health and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes-related nutrition knowledge and dietary intake among adults with type 2 diabetes. Breen, C., Ryan, M., Gibney, MJ., et al.[2022]

A newly developed multifunctional dietary learning aid significantly improved dietary knowledge regarding carbohydrate and fat quantification in diabetic patients after just one lesson.

The dietary aid is particularly beneficial for elderly patients and those with long-standing diabetes, suggesting its effectiveness across diverse patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience in dietary counseling of diabetics with a new multifunctional learning aid]. Stradner, F., Pristautz, H., Zeichen, R., et al.[2006]

References

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

Can peer educators influence healthy eating in people with diabetes? Results of a randomized controlled trial. [2022]

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

Cooking Education Improves Cooking Confidence and Dietary Habits in Veterans. [2022]

3. England pubmed.ncbi.nlm.nih.gov

High saturated-fat and low-fibre intake: a comparative analysis of nutrient intake in individuals with and without type 2 diabetes. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Culinary Medicine Curriculum on Biometric Outcomes, Dietary Habits, and Related Psychosocial Factors among Patients with Diabetes Participating in a Food Prescription Program. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cross-Sector Partnerships for Improved Cooking Skills, Dietary Behaviors, and Belonging: Findings from a Produce Prescription and Cooking Education Pilot Program at a Federally Qualified Health Center. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Enhancing Chronic-Disease Education through Integrated Medical and Social Care: Exploring the Beneficial Role of a Community Teaching Kitchen in Oregon. [2023]

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

Better Together: A Pilot Study on Cooking Matters for Adults With Developmental Disabilities and Direct Support Professionals. [2020]

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

Diabetes-Related Health Care Utilization and Dietary Intake Among Food Pantry Clients. [2023]

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

Food as Medicine: A Pilot Nutrition and Cooking Curriculum for Children of Participants in a Community-Based Culinary Medicine Class. [2021]

10. 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]

11. England pubmed.ncbi.nlm.nih.gov

Diabetes-related nutrition knowledge and dietary intake among adults with type 2 diabetes. [2022]

12. Austria pubmed.ncbi.nlm.nih.gov

[Experience in dietary counseling of diabetics with a new multifunctional learning aid]. [2006]