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Pilot Mobile for Dementia and Frailty (Mindful Meals)

Primary Purpose

Dementia, Frailty

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mobile app
Usual Care
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Diet, Nutrition, Mediterranean Diet

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univeristy of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Intervnetion

Usual Care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Adherence to Mediterranean Diet (aMed) score
MedD adherence outcomes will be measured using the FFQ and adherence to MedD (aMED) score

Secondary Outcome Measures

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.
Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire
Items include questions focused on knowledge about foods and nutrients that are important in the MedD.
Waist Circumference (WC)
WC at the natural waist or narrowest part of the torso will also be measured to the nearest 0.1 cm
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.
Social Cognitive Theory
Social-cognitive theory (SCT) mechanistic variables will be measured using the Food Beliefs Survey and modified to focus on MedD

Full Information

First Posted
April 12, 2023
Last Updated
April 12, 2023
Sponsor
University of Washington
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05827094
Brief Title
Pilot Mobile for Dementia and Frailty
Acronym
Mindful Meals
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Frailty
Keywords
Diet, Nutrition, Mediterranean Diet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile Intervnetion
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Mobile app
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Adherence to Mediterranean Diet (aMed) score
Description
MedD adherence outcomes will be measured using the FFQ and adherence to MedD (aMED) score
Time Frame
Baseline; 12 weeks
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery
Description
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.
Time Frame
Baseline; 12 weeks
Title
Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire
Description
Items include questions focused on knowledge about foods and nutrients that are important in the MedD.
Time Frame
Baseline; 12 weeks
Title
Waist Circumference (WC)
Description
WC at the natural waist or narrowest part of the torso will also be measured to the nearest 0.1 cm
Time Frame
Baseline; 12 weeks
Title
Body Mass Index
Description
Weight to the nearest 0.1 kg and height to the nearest 0.1 cm will be measured and used to compute BMI.
Time Frame
Baseline; 12 weeks
Title
Social Cognitive Theory
Description
Social-cognitive theory (SCT) mechanistic variables will be measured using the Food Beliefs Survey and modified to focus on MedD
Time Frame
Baseline; 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oleg Zaslavsky, PhD, MHA, RN
Phone
206-849-3301
Email
ozasl@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleg Zaslavsky, PhD, MHA, RN
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuan-Ching Wu, BSN
Email
kuancw@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Mobile for Dementia and Frailty

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