Clinical trial NCT05827094: Pilot Mobile for Dementia and Frailty
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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Frailty
Keywords: Diet
Nutrition
Mediterranean Diet
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-04-24
Enrollment: 19
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

1. 65 years or older;
2. 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);
3. mild-to-moderate frailty
4. own a mobile device.

Exclusion Criteria:

1. Severe sensory impairment that makes it impossible to operate a mobile device or respond to prompts
2. English reading level below 6th grade
3. no care partner
4. optimal diet

Primary outcomes:
measure: 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
timeFrame: Baseline; 12 weeks
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: Baseline; 12 weeks
measure: Mediterranean Diet Nutrition Knowledge (MDNK) Questionnaire
timeFrame: Baseline; 12 weeks
measure: Waist Circumference (WC)
timeFrame: Baseline; 12 weeks
measure: Body Mass Index
timeFrame: Baseline; 12 weeks
measure: Social Cognitive Theory
timeFrame: Baseline; 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Univeristy of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Oleg Zaslavsky, PhD, MHA, RN
role: PRINCIPAL_INVESTIGATOR
References: