This study aims to evaluate the effectiveness of NeoMayor, a mobile health (mHealth) intervention designed to improve cardiovascular health among older adults at elevated cardiovascular risk in Chile. NeoMayor is a smartphone-based application that provides personalized guidance on physical activity, diet, sleep, and mental well-being through a multidomain lifestyle approach.
This multicenter randomized controlled trial will enroll community-dwelling older adults aged 55 to 75 years recruited from primary healthcare centers in urban and rural settings. Participants will be randomized in a 2:1 ratio to either the NeoMayor intervention or a control group receiving standard health information and usual care. The intervention duration will be four months.
The primary objective is to determine whether the NeoMayor intervention improves cardiovascular health as measured by the Life's Essential 8 Cardiovascular Health Index. Secondary objectives include evaluating changes in cognitive performance, depressive symptoms, anxiety symptoms, quality of life and physical performance outcomes. The study will also assess feasibility and adherence to digital intervention.
Age between 55 and 75 years
Able to read and understand written instructions
Ownership of a smartphone and ability to use it independently
Physically inactive, defined as performing less than 30 minutes of daily physical activity or less than 2,5 h a week.
Dementia defined as a score in the MEFO < 9
Significant limitations for independent mobility, including use of assistive devices, frailty, gait instability, or lower-limb painful conditions limiting physical activity
Uncorrected hearing or visual impairment preventing adequate use of a smartphone
Chronic neurological, psychiatric, or psychological disorders without regular treatment or follow-up.
Parallel
NeoMayor App
BehavioralNeoMayor is a smartphone-based multidomain lifestyle intervention designed for older adults. The application delivers structured behavioral challenges and personalized recommendations targeting physical activity, healthy diet, sleep quality, and emotional well-being. Participants receive onboarding training and ongoing app-based feedback throughout the 4-month intervention period.
Wearable Device Support
DeviceParticipants randomized to wearable support will receive a commercially available wearable activity tracker synchronized with the NeoMayor application to support self-monitoring of physical activity and health behaviors.
Human Health Coach Support
BehavioralParticipants randomized to coach support will receive monthly contact from a geriatrician to support onboarding, troubleshoot app use, and encourage continued engagement with the app content and challenges. This is an implementation support strategy, not an independent clinical intervention.
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
The primary outcome is the change in the American Heart Association Life's Essential 8 Cardiovascular Health Index (CVHI) from baseline to 4 months. The CVHI is a composite score ranging from 0 to 100, with higher scores indicating better outcome. The score is calculated as the unweighted average of eight cardiovascular health components: smoking status, physical activity, diet quality, sleep duration, body mass index, blood pressure, LDL cholesterol, and fasting glucose. Each component is scored from 0 to 100 according to the American Heart Association scoring algorithm, with higher scores indicating better cardiovascular health.
Cognitive performance
Cognitive performance will be assessed by 3 different test: The Mini-Addenbrooke's Cognitive Examination (scores 0-30, higher scores are better) for global cognition. Trail Making Test - Black \& White A \& B (scores 0-300 sec, ,higher is worse) for attention and cognitive flexibility and the Digit Symbol Substitution Test (DSST) (scores 0-130, higher is better) for processing speed.
Depression
Yesavage Geriatric depression scale 15 (scores 0-15) higher is worse
Anxiety
Geriatric Anxiety Inventory (scores 0-20) higher is worse
Health-Related Quality of Life
Health-Related Quality of Life -12 (scores 0-100) higher is better
Engagement
Number of app sessions, session frequency, total time in-app
Adherence
Percentage of prescribed challenges completed; proportion of planned activities completed
Retention
Proportion of participants remaining active in the intervention through 4 months
Maintenance of app use
App use frequency in the final month compared with the first month.
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University of Chile
Lead sponsor
Agencia Nacional de Investigación y Desarrollo
Collaborator
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