Strengthening, Engaging, and Empowering Dyads Through Nutrition & Wellness

NCT06473129 | Completed

• 2 other identifiers: 2023-152825P30DK111022-09
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Memory Impairment

Outcome Measures

Primary Outcomes (4)

• Change in Public Health Surveillance of Fruit and Vegetable (FV) Intake

  Change in Fruit and Vegetable Intake will be measured using the 6-item Behavioral Risk Factor Surveillance System (BRFSS) fruit and vegetable dietary intake module. The BRFSS assesses the amount of fruit and vegetable consumed, including cooked, raw, fresh, frozen, or canned form, over the past 30 days. As it is based on generic and not episodic memory, dyads can provide a response as to the number of FV per day/week/month (which will be converted to a standard timeframe); never; unsure; or refuse to answer. Responses will be summarized and mean differences post-intervention will be reported. Increased FV intake has been associated with lower risks of cognitive disorders and chronic diseases and, in this study, will assess the impact of FFL on FV intake.

  Baseline and 6 weeks

• Change in Self Efficacy for Diabetes

  Change in diabetes self-efficacy will be assessed using the 8-item Stanford Diabetes Self Efficacy Scale. Each item is scored on a scale of 1 ('Not confident at all') through 10 ('Totally confident') for a total possible range of 8-80, if every question is properly answered. The score for each item is the number circled. If two consecutive numbers are circled, the lower number is coded. If the numbers are not consecutive that item is not scored. If more than two items are missing the score is invalidated. The score for the scale is the mean of the items and mean differences in scale scores post-intervention will be reported. Higher scores indicate higher level of diabetes self-efficacy and the impact of the FFL on diabetes self-efficacy in this study.

  Baseline and 6 weeks

• Change in Diabetes Self-Management

  Change in Diabetes Self-Management will be assessed using the 16-item Diabetes Self-Management Questionnaire (DSMQ). Each item is scored on a 4-point Likert scale ranging from 0 ('Does not apply to me') through 3 ('Applies to me very much') for a possible range of 0-48. The score for the scale is the mean of the items and mean differences in scale scores post-intervention will be reported. Higher scores indicate higher level of diabetes self-care and the impact of the FFL on diabetes self-efficacy in this study.

  Baseline and 6 weeks

• Change in Diabetes Management

  Changes in Diabetes management will be assessed by virtue of mean weekly glucose logs or continuous glucose monitors. Mean changes in glucose levels post-intervention (in units of mg/dL) will be reported. Normal fasting glucose levels ranges vary. Normal glucose levels are associated with more favorable health outcomes and the impact of the FFL on diabetes (glucose) management in this study.

  Baseline and 6 weeks

Secondary Outcomes (5)

• Change in Geriatric Depression

  Baseline and 6 weeks

• Change in Caregiver Stress/Burden

  Baseline and 6 weeks

• Dietary Pattern

  Baseline and 6 weeks

• Cognitive Assessment

  Baseline

• Household Food Security

  Baseline

Study Arms (1)

Food for Life Culinary Workshop

EXPERIMENTAL

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.

Behavioral: Food for Life Culinary Workshops

Interventions

Food for Life Culinary Workshops 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.

Food for Life Culinary Workshop

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Memory Disorders

Interventions

Food

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Mirnova Ceide, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm pilot

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 25, 2024
• Study Start: August 1, 2023
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)