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
Phase: NA
Conditions: Dementia, Frailty
Sponsor: University of Washington

Pilot Mobile for Dementia and Frailty (Mindful Meals) 
NCT05827094 
April 23,  2023 

STUDY PROTOCOL 
 
 
Objective 
 
We conducted a pilot randomized controlled trial (RCT) to assess the feasibility and preliminary 
efficacy of an innovative, theory-driven mobile intervention specifically designed for older adults 
with frailty and dementia, aimed at increasing Mediterranean food consumption. Primary efficacy 
outcome was adherence to the Mediterranean diet score. 
 
Design 
 
This was a pilot randomized control trial (RCT) to test the feasibility and preliminary 
efficacy of a mobile intervention consisting of a patient-facing mobile app and a secure 
web-based administrative dashboard. Participants were randomly assigned to either the 
intervention group or the control group. Those randomized to the intervention received 
access to a mobile app, available for download by invitation only on the Apple App Store. 
Participants randomized to control received via email referral to National Institute on 
Aging (NIA) materials concerning healthy eating. 
 
Methods 
 
 
Participants 
Eligibility criteria included: a) being age 65 years and older, b) having difficulty with at 
least one of the following activities: performing heavy housework; performing light 
housework; walking outside alone; managing money/paying bills; shopping for personal 
items; preparing meals, suggestive of frailty, 3) being diagnosed with early dementia or 
having memory symptoms suggestive of mild cognitive impairment.  Exclusion criteria 
included: a) having difficulty with basic activities of daily living such as eating and getting 

out of bed, suggestive of overt disability, b) having a 14-item Mediterranean Diet 
Adherence Screener (MEDAS) >8, suggestive of an optimal diet, d) severe hearing or 
visual impairment. 
 
STATISTICAL ANALYSIS PLAN 
 
Descriptive statistics were first calculated to compare demographic characteristics 
between the intervention and the control groups. Outcomes measures were analyzed by 
calculating the within-group pretest–post-test change scores and then comparing the 
change scores between the intervention and the control groups using Mann–Whitney U 
tests. To estimate the magnitude of the intervention's impact compared to the control 
group, we used Hedges' g to measure effect size. Hedges' g is a variation of Cohen's d 
that corrects for biases that may occur in small sample sizes, making it a more 
appropriate choice for our study. Hedges' g takes the difference in means between the 
intervention and control groups and divides it by the pooled standard deviation while 
applying a correction factor to account for potential biases. A larger absolute value of 
Hedges' g indicates a greater effect size, with values of 0.2, 0.5, and 0.8 generally 
considered small, medium, and large effect sizes, respectively. An R package, “BootES” 
was used to calculate 95% bootstrap confidence intervals for the effect sizes. The 
"BootES" package is designed specifically for this purpose, providing a robust and 
efficient method for estimating confidence intervals based on resampling techniques. 
Finally, descriptive statistics and visual analytics were used to describe app quality and to 
analyze log data of user interactions.