- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05827094
Pilot Mobile for Dementia and Frailty (Mindful Meals)
May 6, 2024 updated by: Oleg Zaslavsky, University of Washington
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
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 Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98195
- Univeristy of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 65 years or older;
- ICD-9-CM (ICD-10-CM) codes for mild or major neurocognitive disorders with mild-to-moderate severity due to several possible etiologies. Specifically, a) mild neurocognitive disorder 331.83 (G31.84); major neurocognitive disorder 294.1x (F02.8x) due to Alzheimer disease 331.0 (G30.9); frontotemporal lobar degeneration 331.19 (G31.09); Lewy body disease 331.82 (G31.83);
- mild-to-moderate frailty
- own a mobile device.
Exclusion Criteria:
- Severe sensory impairment that makes it impossible to operate a mobile device or respond to prompts
- English reading level below 6th grade
- no care partner
- optimal diet
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile Intervnetion
Participants randomized to the intervention arm will receive verbal and written instructions as well as one-on-one demonstration of the app features.
Participants will have an option of either receiving the study mobile device or will be able to use their own device with an installed app.
Following the training, participants will be asked to use the app at least once a week.
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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.
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Active Comparator: Usual Care
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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to Mediterranean Diet (aMed) score
Time Frame: Baseline; 12 weeks
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MedD adherence outcomes will be measured using the FFQ and adherence to MedD (aMED) score
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Baseline; 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Physical Performance Battery
Time Frame: Baseline; 12 weeks
|
The Short Physical Performance Battery (SPPB) is designed to measure functional status and physical performance.
The scale is a composite measure assessing walking speed, standing balance, and sit-to-stand performance.
The three tests are summed to give a total score, with a maximum of 12 and a minimum of 0, with a higher score indicating higher function.
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Baseline; 12 weeks
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Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire
Time Frame: Baseline; 12 weeks
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Items include questions focused on knowledge about foods and nutrients that are important in the MedD.
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Baseline; 12 weeks
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Waist Circumference (WC)
Time Frame: Baseline; 12 weeks
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WC at the natural waist or narrowest part of the torso will also be measured to the nearest 0.1 cm
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Baseline; 12 weeks
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Body Mass Index
Time Frame: Baseline; 12 weeks
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Weight to the nearest 0.1 kg and height to the nearest 0.1 cm will be measured and used to compute BMI.
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Baseline; 12 weeks
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Social Cognitive Theory
Time Frame: Baseline; 12 weeks
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Social-cognitive theory (SCT) mechanistic variables will be measured using the Food Beliefs Survey and modified to focus on MedD
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Baseline; 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oleg Zaslavsky, PhD, MHA, RN, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
March 30, 2024
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
April 12, 2023
First Posted (Actual)
April 24, 2023
Study Record Updates
Last Update Posted (Actual)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00015813
- 5P30DK017047-45 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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