Pilot Mobile for Dementia and Frailty

NCT05827094 | Completed Results

• 2 other identifiers: STUDY000158135P30DK017047-45
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dementia; Frailty

Keywords

Diet; Nutrition; Mediterranean Diet

Outcome Measures

Primary Outcomes (1)

• Change in Adherence to Mediterranean Diet (aMed) Score. The Change Was Calculated From Two Time Points as the Value at the Later Time Point Minus the Value at the Earlier Time Point

  Mediterranean Diet adherence was measured using an Food Frequency Questionnaire (FFQ) adherence to Mediterranean Diet (aMED) score. The self-administered FFQ asks participants to report the frequency of consumption and portion size of approximately 125-line items over the last 3 months. A series of foods or beverages define each line item. The aMED score was designed to assess adherence to a Mediterranean dietary pattern. aMED scores range from 0 (nonadherence) to 9 (perfect adherence)

  Baseline; 12 weeks

Secondary Outcomes (5)

• Short Physical Performance Battery

  Baseline; 12 weeks

• Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire

  Baseline; 12 weeks

• Waist Circumference (WC)

  Baseline; 12 weeks

• Body Mass Index

  Baseline; 12 weeks

• Social Cognitive Theory

  Baseline; 12 weeks

Study Arms (2)

Mobile Intervnetion

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Usual Care OTHER

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).

Usual Care

Mobile app OTHER

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.

Mobile Intervnetion

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Univeristy of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Dementia; Frailty

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Associate Professor
• Organization: University of Washington School of Nursing

ozasl@uw.edu

2068493301

Study Officials

• Oleg Zaslavsky, PhD, MHA, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor- School of Nursing

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: June 6, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)