Effectiveness of NeoMayor in Improving Cardiovascular Health (NEOMAYOR)

June 2, 2026 updated by: University of Chile

Effectiveness of NeoMayor in Improving Cardiovascular Health Status in Chilean Adults

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Population aging in low- and middle-income countries has led to an increasing burden of non-communicable diseases, particularly cardiovascular disease and dementia. A substantial proportion of cardiovascular and dementia risk factors are modifiable, making lifestyle-based preventive interventions a public health priority.

Multidomain interventions targeting physical activity, diet, sleep, and psychosocial factors have demonstrated effectiveness in reducing cardiovascular risk and supporting cognitive health. However, implementation barriers such as limited access, low adherence, and healthcare inequities reduce their impact in real-world settings.

Mobile health interventions offer a scalable alternative, particularly in settings with increasing smartphone adoption among older adults. NeoMayor was developed using a user-centered design approach and demonstrated feasibility and potential effectiveness in a pilot study conducted in Chile.

This study will evaluate the effectiveness of NeoMayor in improving cardiovascular health using the Life's Essential 8 Cardiovascular Health Index, a composite measure developed by the American Heart Association that includes modifiable behavioral and biological cardiovascular risk factors. The trial will also explore cognitive and mental health outcomes as well as pshysical performance associated with lifestyle improvement.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
      • Tiltil, Chile
        • Hospital de Til til Daniel Moya #100
    • Independencia
      • Santiago, Independencia, Chile, 8380456
        • Hospital clinico Universidad de Chile. Carlos Lorca Tobar 999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Intermediate or high cardiovascular risk, defined as the presence of at least three of the following:

Hypertension (history diagnosed by specialist or general practitioner or

≥ 140 mmHg systolic or ≥90 mm Hg diastolic blood pressure at baseline or current antihypertensive treatment) Diabetes mellitus (history diagnosed by specialist or general practitioner or or fasting blood glucose ≥126 mg/dL or current pharmacologic treatment). Obesity (BMI ≥30 kg/m²) Dyslipidaemia (history diagnosed by specialist or general practitioner or lipid-lowering drugs or baseline total cholesterol ≥ 200 mg/dL or LDL cholesterol ≥100 mg/dL) Exclusion Criteria

Participants meeting any of the following criteria will be excluded:

Dementia defined as a socre in the Mini-ACE < 21 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.

Present severe alcohol or illicit drug use. Severe or terminal illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeoMayor app
Participants will receive access to the NeoMayor mobile health application designed to promote healthy lifestyle behaviors through structured behavioral challenges targeting physical activity, diet, sleep, and mental well-being during 4 months. Participants in this arm will additionally be randomized to receive the intervention with or without wearable device suppor
Behavioral: NeoMayor App
NeoMayor 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.
Other Names:
  • mhealth
  • mobile software
Device: Wearable Device Support
Participants 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.
No Intervention: Control Group
Participants will receive standard health information and continue with their usual healthcare provided by the public health system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
Time Frame: Baseline and 4 months

The primary outcome is the change in the Life's Essential 8 Cardiovascular Health Index (CVHI) from baseline to 4 months. The CVHI is a composite cardiovascular health score ranging from 0 to 100, with higher scores indicating better cardiovascular health status.

The index is based on the eight cardiovascular health components defined by the American Heart Association Life's Essential 8 framework, including:Smoking status,Physical activity,Diet quality,Sleep duration,Body mass index (BMI),Blood pressure,LDL cholesterol,Fasting glucose.

Each component is standardized according to published scoring algorithms and combined to generate the overall cardiovascular health score. The primary analysis will evaluate the between-group difference in change in CVHI over time.
Baseline and 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global cognition
Time Frame: Baseline and 4 months
Mini-Addenbrooke's Cognitive Examination
Baseline and 4 months
Attention and cognitive flexibility
Time Frame: Baseline and 4 months
Trail Making Test - Black & White
Baseline and 4 months
Cognitive processing speed
Time Frame: Baseline and 4 months
Digit Symbol Substitution Test (DSST)
Baseline and 4 months
Depression
Time Frame: Baseline and 4 months
Geriatric depression scale
Baseline and 4 months
Anxiety
Time Frame: Baseline and 4 months
Geriatric Anxiety Inventory
Baseline and 4 months
Health-Related Quality of Life
Time Frame: Baseline and 4 months
Health-Related Quality of Life -12
Baseline and 4 months
Loneliness
Time Frame: baseline and 4 months
UCLA 3 questions
baseline and 4 months
Global physical performance
Time Frame: Baseline and 4 months
Short physical performance battery
Baseline and 4 months
Balance systems
Time Frame: Baseline and 4 months
Mini best Test
Baseline and 4 months
Modifiable dementia risk factors
Time Frame: Baseline and 4 months
LIBRA score
Baseline and 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Collaborators

Agencia Nacional de Investigación y Desarrollo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • neomayor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers.

IPD Sharing Time Frame

Data will be available beginning 12 months after the completion of the study and for a period of 5 years thereafter

IPD Sharing Access Criteria

Data will be shared with researchers who provide a methodologically sound proposal and have institutional review board (IRB) approval. Requests should be directed to cdelgado@uchile.cl. To gain access, data requestors will need to sign a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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