Pilot Mobile for Dementia and Frailty
Public ClinicalTrials.gov record NCT05827094. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pilot Evaluation of a Mobile Intervention to Support Mediterranean Diet (MedD) for Persons With Mild Alzheimer Disease and Alzheimer Disease Related Dementia's (AD/ADRD) and Frailty
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this project, we propose to build on our Stage I formative work (according to the NIH Stage Model for Behavioral Intervention Development), where we developed fully functional prototypes of a mobile intervention aimed at improving adherence to Mediterranean Diet (MedD) for older adults with frailty and early dementia to complete the Stage II exploratory work, where the intervention will undergo further feasibility, acceptability, and preliminary efficacy tests. The intervention includes a patient-facing app that allows users to track their diet and receive personalized feedback concerning opportunities for improvement and recipes for breakfast, lunch, dinner, and snacks, informational materials about MedD, and a chat feature. On the other end, a web-based provider interface allows clinicians to review patient progress, suggest meal plans, and send and receive messages. The pilot randomized controlled trial, conducted over three months, will compare usual care to usual care plus mobile intervention to gather preliminary efficacy data concerning a change in adherence to MedD score (primary outcome). Mechanistic and secondary outcomes will include MedD knowledge, constructs from Social Cognitive Theory (self-efficacy, outcome expectation, self-regulation, and social support), platform use, anthropometric, and functional measures. Feasibility will be evaluated in terms of recruitment and retention outcomes. Acceptability will be determined through post-intervention semi-structured interviews and structured survey measures.
Study identification
- NCT ID
- NCT05827094
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 19 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 65 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 5, 2023
- Primary completion
- Mar 14, 2024
- Completion
- Mar 14, 2024
- Last update posted
- Mar 12, 2025
2023 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univeristy of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05827094, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05827094 live on ClinicalTrials.gov.