Strengthening, Engaging, and Empowering Dyads Through Nutrition & Wellness

Completed · Not applicable

Conditions studied: Diabetes, Memory Impairment

In brief

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.

Key facts

Study ID

NCT06473129

Run by

Montefiore Medical Center

People needed

26

Starts

2023-08-01

Expected to finish

2025-06-05

Last updated by the study team

2025-07-01

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 65 years old or older
• have a diagnosis of Type II diabetes
• Must have cognitive impairment (Subjective Cognitive Complaint and Picture Based Memory Impairment Screen (PMIS ≥5))
• Care partner who will attend workshops (care partner 18 years or older) is preferred
• Receiving care at a CEAD site (the Center for the Aging Brain and the Geriatrics Ambulatory Practice)
• Fluent in English or Spanish
• Able to attend and engage in 2-hour classes in-person or virtually

You may not qualify if…

• <65 years old
• Not fluent in English or Spanish
• Too medically unstable to attend workshops
• Too cognitively impaired (PMIS ≤4) to engage in workshops or provide informed consent
• Psychiatrically unstable (i.e., Suicidal ideation)
• Hearing impairment impeding ability to engage in Food for Life classes
• Participation in a nutrition program in the last 6 months

Where it is running

• Albert Einstein College of Medicine — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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