CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Mobile app +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05827094
NCT05827094N/ACompleted

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

University of Washington·interventional·Posted Apr 24, 2023·Updated Mar 13, 2025

In Brief

A clinical study evaluating Mobile app and Usual Care for Dementia and Frailty. Completed, enrolled 19 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia, Frailty
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedApr 24, 2023
Enrollment StartJun 6, 2023
Primary CompletionMar 15, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.2 years ago

Interventions

Mobile appother

The main mobile intervention features. Tracking and immediate feedback: Pressing the icon launches a short series of questions with multiple-choice response options focusing on recent meals . The survey items are modeled after the 14-item Mediterranean Adherence Screener using simplified language and intuitive visuals to lower cognitive load. Based on responses to the survey, the app provides an intuitive visualization of the survey results, personalized feedback, and recipes on how to improve the person's diet. On-demand resources: individuals are able to access on-demand resources about the MedD diet, its benefits, and best dietary practices. The recipe page includes a personalized list of simple breakfast, lunch, dinner, and snack recipes based on the survey results with step by step instructions on how to prepare Mediterranean foods. In-app messaging: Individuals are able to receive notifications and send and receive messages.

Usual Careother

Participants randomly allocated to the control group will receive educational materials on healthy eating, as provided on the NIA web page (https://www.nia.nih.gov/health/healthy-eating).