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NCT06473129 · ClinicalTrials.gov registry record · NA

Strengthening, Engaging, and Empowering Dyads Through Nutrition & Wellness

A NA study, sponsored by Montefiore Medical Center.

Completed
Registry status
NA
Development phase
26
Enrollment target

NCT06473129: Completed NA study, sponsored by Montefiore Medical Center.

NCT06473129 is a NA study that has completed, run by Montefiore Medical Center. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06473129, a NA study, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
NA
Development phase
26 participants
Enrollment target

Study 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.

Primary Outcome

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 refu

Interventions

  • BEHAVIORAL Food for Life Culinary Workshops

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2023-08-01
Est. Completion 2025-06-05
Phase NA
Montefiore Medical Center

345 total trials

What the finished NCT06473129 record still lists

NCT06473129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Food for Life Culinary Workshops is the first listed.

NCT06473129 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06473129 about?

NCT06473129 is a clinical study titled "Strengthening, Engaging, and Empowering Dyads Through Nutrition & Wellness". 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...

What is the current status of trial NCT06473129?

This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2023-08-01. Estimated completion is 2025-06-05.

What interventions are being tested in trial NCT06473129?

The interventions under investigation include: Food for Life Culinary Workshops (BEHAVIORAL).

Who is sponsoring clinical trial NCT06473129?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06473129's enrollment target sits among peer trials

26 1710th of 2000 higher than 289 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06473129, the US trial registry maintained by the National Library of Medicine. NCT06473129 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.