Nutrition Workshops for Diabetes and Memory Loss

(SEED Trial)

No longer recruiting at 1 trial location

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Under 65, Not fluent, Medically unstable, others

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

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how plant-based nutrition classes can help older adults manage type 2 diabetes and memory issues. Participants will attend Food for Life Culinary Workshops, which teach cooking and nutrition skills to improve blood sugar control and support cognitive health. The trial targets individuals aged 65 or older with type 2 diabetes and memory problems, who have a care partner and can attend sessions either in person or online. The goal is to determine if these workshops are helpful, easy to follow, and impactful in participants' daily lives. As an unphased trial, this study provides participants the opportunity to contribute to innovative research that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nutrition workshops for diabetes and memory loss.

What prior data suggests that this nutritional educational series is safe for older adults with Type 2 diabetes and cognitive impairment?

Research has shown that participating in cooking and nutrition workshops can be safe and beneficial for managing diabetes. For example, a study on the "Cooking Matters for Diabetes" program found that participants responded positively. They often join cooking demonstrations and learn to manage diabetes through diet and exercise. These programs report no major side effects, indicating safe management.

Another study, "Food Is Medicine," demonstrated that similar programs can improve diet quality and aid in diabetes management without significant risks. These findings support the idea that workshops like the Food for Life Culinary Workshops are safe for people with diabetes and cognitive challenges. Participants can expect to learn about healthy cooking and eating with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for diabetes and memory loss that often rely on medication, Food for Life Culinary Workshops introduce a hands-on, educational approach. This program combines nutrition education with practical cooking demonstrations, empowering participants to make healthier food choices. Researchers are excited about this treatment because it fosters lifestyle changes that could potentially improve both blood sugar control and cognitive function, offering a holistic alternative to traditional medical interventions.

What evidence suggests that this nutritional workshop is effective for diabetes and memory loss?

Research has shown that a Whole Food, Plant-Based (WFPB) diet can help manage type 2 diabetes by lowering blood sugar levels and reducing the need for insulin. In this trial, participants will attend the Food for Life Culinary Workshops, designed to improve diabetes management. These programs provide education and support, which have been linked to improved blood sugar control and better health over time. Additionally, these workshops can enhance self-care habits and overall quality of life, especially for those with limited food access. This makes the workshops a promising method for managing diabetes and may also help reduce the risk of related memory problems. ^{5 6 7 8 9}

Who Is on the Research Team?

Mirnova Ceide, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above with Type 2 diabetes and cognitive impairment, along with their care partners. They will participate in nutrition classes focused on a Whole Food, Plant Based diet at a local senior center. Participants must be able to attend all sessions and have the ability to provide informed consent.

Inclusion Criteria

Must have cognitive impairment (Subjective Cognitive Complaint and Picture Based Memory Impairment Screen (PMIS ≥5))

Receiving care at a CEAD site (the Center for the Aging Brain and the Geriatrics Ambulatory Practice)

I am 65 years old or older.

Exclusion Criteria

Participation in a nutrition program in the last 6 months

I am able to understand and participate in workshops.

Psychiatrically unstable (i.e., Suicidal ideation)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Screening and consent will take place by phone

Treatment

Participants attend 4 Whole Food, Plant Based nutrition classes, each consisting of 1 hour of education and 1 hour of a culinary demonstration. Two care partner support sessions are included at weeks 3 and 6.

6 weeks

4 in-person classes, 2 in-person support sessions

Follow-up

Participants are monitored for changes in dietary patterns, diabetes management, and cognitive assessments post-intervention

6 weeks

Debriefing interviews and assessments

Evaluation

Qualitative feedback is gathered through debriefing interviews and stakeholder studio sessions to assess the implementation and efficacy of the intervention

What Are the Treatments Tested in This Trial?

Interventions

• Food for Life Culinary Workshops

Trial Overview The study tests a nutritional educational series involving WFPB diet classes and support sessions for people with Type 2 diabetes and memory loss. It aims to see if this can improve blood glucose control, self-efficacy in managing diabetes, and adherence to the MIND diet pattern.

How Is the Trial Designed?

Group I: Food for Life Culinary Workshop Experimental Treatment 1 Intervention

winning Food for Life (FFL) classes are 2 hours and include: 1 hour of education and 1 full hour of a culinary demonstration. All participants receive printed program guidebooks with resources and recipes. Each language specific cohort will have (15 in-person dyads) for a total of 30 participant-care partner dyads (N=60). 2 care partner roundtable sessions at week 3 and week 6 are also included.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10862535/

A 6-week Randomized, Controlled Cooking and Diabetes Self ... Our aim was to test whether a cooking intervention with food provision and diabetes self-management education and support improves HbA1c and diabetes ...

2. pcrm.org pcrm.org/good-nutrition/plant-based-diets/ffl/class-descriptions

Food For Life - Class Descriptions Classes will also help participants seeking to prevent or overcome high blood pressure, heart disease, type 2 diabetes, and other health conditions that ...

3. jneb.org jneb.org/article/S1499-4046(25)00040-5/fulltext

Cooking Matters for Diabetes: A Curriculum to Support ... A curriculum to support diabetes self-management among individuals facing food insecurity. Jennifer A. Garner, PhD, RD

4. jandonline.org jandonline.org/article/S2212-2672(22)00719-5/abstract

Outcomes of Cooking Matters for Diabetes: A 6-week ... Cooking Matters for Diabetes may be an effective method of improving diet-related self-care and health-related quality of life, especially among food insecure ...

5. chcs.org chcs.org/media/Improving-Diabetes-Outcomes-Through-Home-Delivery-Healthy-Foods-and-Education.pdf

Improving Diabetes Outcomes Through Home-Delivered ... Key Outcomes: Increased health-promoting behaviors (annual wellness visits, diabetes eye exams, completion of health plan health risk assessment, diabetes self- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10909744/

Feasibility of Cooking Matters for Diabetes: A 6-week ... Our aim was to assess the feasibility of a cooking intervention with food provision and diabetes self-management education and support.

7. civileats.com civileats.com/2024/07/01/can-cooking-in-community-slow-dementia-and-diabetes/

Can Cooking in Community Slow Dementia and Diabetes? New cooking classes for older people of color could delay the onset of diet-related diseases—and provide a host of other benefits, too.

8. wexnermedical.osu.edu wexnermedical.osu.edu/mediaroom/pressreleaselisting/cooking-matters

Cooking, diabetes self-management education ... The weekly classes included cooking demonstrations along with lessons on diabetes and treatment options; healthy eating; physical activity; ...

9. jacc.org jacc.org/doi/10.1016/j.jacc.2023.12.023

“Food Is Medicine” Strategies for Nutrition Security and ... Programs include medically tailored meals, groceries, and produce prescriptions, with varying levels of nutrition and culinary education. Supportive advances ...