Effectiveness of NeoMayor in Improving Cardiovascular Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-75
SponsorUniversity of Chile

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

Dementia defined as a score 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.

Trial design

Treatments tested in this trial

  • NeoMayor App
  • Wearable Device Support

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Chile

Lead sponsor

Agencia Nacional de Investigación y Desarrollo

Collaborator