Clinical trial NCT06473129: Strengthening, Engaging, and Empowering Dyads Through Nutrition & Wellness
Official title: Strengthening, Engaging, and Empowering Dyads Through Nutrition & Wellness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes
Memory Impairment
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Public Health Surveillance of Fruit and Vegetable (FV) Intake
timeFrame: Baseline and 6 weeks
measure: Change in Self Efficacy for Diabetes
timeFrame: Baseline and 6 weeks
measure: Change in Diabetes Self-Management
timeFrame: Baseline and 6 weeks
measure: Change in Diabetes Management
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Geriatric Depression
timeFrame: Baseline and 6 weeks
measure: Change in Caregiver Stress/Burden
timeFrame: Baseline and 6 weeks
measure: Dietary Pattern
timeFrame: Baseline and 6 weeks
measure: Cognitive Assessment
timeFrame: Baseline
measure: Household Food Security
timeFrame: Baseline
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Mirnova Ceide, MD
role: PRINCIPAL_INVESTIGATOR
References: