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Mobile App for Dementia and Frailty (Mindful Meals Trial)

Phase 1 & 2
Led By Oleg Zaslavsky, PhD, MHA, RN
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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: 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)
Screening 3 weeks
Treatment Varies
Follow Up baseline; 12 weeks
Awards & highlights

Mindful Meals Trial Summary

This trial will test a mobile app and web-based provider interface to help older adults with frailty & dementia stick to the Mediterranean Diet, with outcomes such as knowledge, self-efficacy, & retention measured.

Who is the study for?
This trial is for older adults aged 65 or above with mild-to-moderate frailty and early dementia who own a mobile device. Participants should have certain neurocognitive disorders but must be able to read English at a 6th-grade level, have a care partner, and not already be on an optimal diet.Check my eligibility
What is being tested?
The study tests a mobile app designed to improve adherence to the Mediterranean Diet among older adults with frailty and early dementia. It includes tracking features, personalized feedback, recipes, educational materials about the diet, and communication tools for clinicians.See study design
What are the potential side effects?
Since this intervention involves using a mobile app for dietary management rather than medication or invasive procedures, side effects are minimal but may include frustration or stress from learning new technology.

Mindful Meals Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 65 years old or older.
I have been diagnosed with a mild to moderate neurocognitive disorder.

Mindful Meals Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to Mediterranean Diet (aMed) score
Secondary outcome measures
Body Mass Index
Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire
Short Physical Performance Battery
+2 more

Mindful Meals Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mobile IntervnetionExperimental Treatment1 Intervention
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.
Group II: Usual CareActive Control1 Intervention
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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Who is running the clinical trial?

University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,373 Total Patients Enrolled
2 Trials studying Frailty
41 Patients Enrolled for Frailty
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,048 Total Patients Enrolled
2 Trials studying Frailty
26 Patients Enrolled for Frailty
Oleg Zaslavsky, PhD, MHA, RNPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Frailty
15 Patients Enrolled for Frailty

Media Library

Mobile app Clinical Trial Eligibility Overview. Trial Name: NCT05827094 — Phase 1 & 2
Frailty Research Study Groups: Mobile Intervnetion, Usual Care
Frailty Clinical Trial 2023: Mobile app Highlights & Side Effects. Trial Name: NCT05827094 — Phase 1 & 2
Mobile app 2023 Treatment Timeline for Medical Study. Trial Name: NCT05827094 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participation in this research project?

"As verified through clinicaltrials.gov, this medical trial is actively enrolling patients. This trail was initially made available on July 1st 2022 and the most recent update took place April 12th 2023."

Answered by AI

How many participants have signed up for this experiment?

"Correct. According to clinicaltrials.gov, this medical project was initiated on July 1st 2022 and is still actively calling for participants. 18 volunteers are needed at a single location."

Answered by AI
~2 spots leftby Jun 2024