Pilot Mobile for Dementia and Frailty

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dementia, Frailty

Intervention / Treatment
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* Other: Mobile app
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Intervnetion<br>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. | Other: Mobile app<br>* 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.<br>|
| Active Comparator: Usual Care<br>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). | Other: Usual Care<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Mediterranean Diet (aMed) score | MedD adherence outcomes will be measured using the FFQ and adherence to MedD (aMED) score | Baseline; 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery | 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. | Baseline; 12 weeks | 
| Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire | Items include questions focused on knowledge about foods and nutrients that are important in the MedD. | Baseline; 12 weeks | 
| Waist Circumference (WC) | WC at the natural waist or narrowest part of the torso will also be measured to the nearest 0.1 cm | Baseline; 12 weeks | 
| Body Mass Index | Weight to the nearest 0.1 kg and height to the nearest 0.1 cm will be measured and used to compute BMI. | Baseline; 12 weeks | 
| Social Cognitive Theory | Social-cognitive theory (SCT) mechanistic variables will be measured using the Food Beliefs Survey and modified to focus on MedD | Baseline; 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Nutrition, Mediterranean Diet