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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 is a NA study that has completed, run by Montefiore Medical Center. The registered enrollment target is 26 participants.
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.
Interventions
- BEHAVIORAL Food for Life Culinary Workshops
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2025-06-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06473129
The ClinicalTrials.gov registry entry for NCT06473129 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Food for Life Culinary Workshops is the first listed.
NCT06473129 reports 0 study locations.
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.
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