Nutrition Workshops for Diabetes and Memory Loss

(SEED Trial)

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

A meta-analysis of over 2.3 million individuals in 14 studies showed that individuals with type II diabetes (T2DM) are at a 60% increased risk for development of any dementia compared to those without T2DM. A Whole Food, Plant Based dietary (WFPB) pattern has been associated with lower blood glucose levels and decreased insulin requirements. As older adults at risk for Alzheimer's disease (AD) may be dependent on care partners for nourishment, it is imperative to involve the caregiving dyad in a lifestyle intervention. The investigator team proposes a collaboration between our center of excellence for AD and a community-based organization (CBO) that empowers people through WFPB nutrition. This study will pilot a dyad-focused nutritional educational series for older adults with Type 2 diabetes mellitus (T2DM) and cognitive impairment (CI) and their care partners in a local senior center. In this single arm study, 2 cohorts (English N=15 and Spanish N=15) of older adults (\>=65) with T2DM and CI and their care partners will be recruited to participate in 4 WFPB nutrition classes. Each class consists of: 1 hour of education and 1 hour of a culinary demonstration. Two care partner support sessions co-led by the nutrition facilitator and geriatric social worker at weeks 3 and 6 will also be included. In order to establish feasibility, important baseline characteristics of participants including: food insecurity, cognition (Telephone MoCA), and multisensory integration (CatchU® mobility application) will be assessed. Acceptability, appropriateness, and feasibility of the intervention will be assessed quantitatively and qualitatively in debrief interviews. The preliminary efficacy on the intervention dietary pattern (including the MIND diet screen), diabetes self-efficacy, and diabetes management: mean weekly glucose (logs and continuous glucose monitors) will be evaluated.

Research Team

Mirnova Ceide, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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

I am 65 years old or older.

I have been diagnosed with Type II diabetes.

Exclusion Criteria

I am too ill to attend workshops.

Psychiatrically unstable (i.e., Suicidal ideation)

Participation in a nutrition program in the last 6 months

Timeline

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

Treatment Details

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.

Participant Groups

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+