Strengthening, Engaging, and Empowering Dyads Through Nutrition & Wellness

NCT ID: NCT06473129

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-06-05

Brief Summary

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.

Detailed Description

One English speaking and one Spanish Speaking cohort of patient-care partner dyads to participate in the Plant Powered Metro NY (PPMNY) Food for Life class series will be recruited. The Physicians Committee for Responsible Medicine's award-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). Two care partner roundtable sessions will also be included at week 3 and week 6. Classes will be held in a convenient location in the Bronx, NY. Jewish Association Serving the Aging (JASA) has previously provided space for similar activities.

Older adults (≥65) with diabetes and cognitive impairment (CI) and their care partners from the Montefiore Hudson Valley Center of Excellence for Alzheimer's Disease (CEAD) will primarily be recruited. The Montefiore CEAD is one of ten CEADs supported in part by a grant from the New York State Department of Health and provides outpatient-based multispecialty dementia care utilizing a consultative model. The patient population largely originates from Bronx County and seven counties in the Hudson Valley region: Westchester, Rockland, Putnam, Dutchess, Sullivan, Orange, and Ulster. The overall Montefiore CEAD patient population is diverse, with >40% of patients Non-Hispanic Black or Hispanic.

Aim 1: A mixed methods approach to assess the implementation of the SEED intervention in a diverse, older adult cohort will be used. Qualitative: At the end of the FFL class series (or at time prior if patient decides to drop out), debriefing interviews with all participant-care partner dyads will be provided to gather qualitative feedback. After both English and Spanish cohorts have completed the class series, a stakeholder studio with the PPMNY FFL facilitators and CEAD team will be conducted.

Aim 2: The primary goal is to determine the preliminary efficacy of dyad focused FFL class series on FV intake, diabetes self-efficacy and management in 30 participant/care partner dyads (N=60). Participants will be recruited from the Montefiore Hudson Valley CEAD clinic sites including the Geriatrics Ambulatory Practice, Bronx, NY and the Center for the Aging Brain, Yonkers NY. Screening and consent will take place by phone.

Conditions

Diabetes; Memory Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Food for Life Culinary Workshop

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.

Group Type: EXPERIMENTAL

Food for Life Culinary Workshops

Intervention Type: BEHAVIORAL

Whole food, plant based 2hr workshop, which includes background information on diabetes, how to shop for food, etc and then a culinary demonstration and tasting of whole food, plant based dishes.

Interventions

Food for Life Culinary Workshops

Whole food, plant based 2hr workshop, which includes background information on diabetes, how to shop for food, etc and then a culinary demonstration and tasting of whole food, plant based dishes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Adults 65 years old or older

2. have a diagnosis of Type II diabetes

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

4. Care partner who will attend workshops (care partner 18 years or older) is preferred

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

6. Fluent in English or Spanish

7. Able to attend and engage in 2-hour classes in-person or virtually

Exclusion Criteria

1. <65 years old

2. Not fluent in English or Spanish

3. Too medically unstable to attend workshops

4. Too cognitively impaired (PMIS ≤4) to engage in workshops or provide informed consent

5. Psychiatrically unstable (i.e., Suicidal ideation)

6. Hearing impairment impeding ability to engage in Food for Life classes

7. Participation in a nutrition program in the last 6 months

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirnova Ceide, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Other Identifiers

5P30DK111022-09

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-15282

Identifier Type: -

Identifier Source: org_study_id