Effectiveness of NeoMayor in Improving Cardiovascular Health

Sponsor
University of Chile
Study ID
NCT07633392
Status
Not Yet Recruiting

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Conditions

  • Blood Pressure
  • Body Mass Index
  • Cardiovascular Health Status
  • Diet Quality
  • Fasting Glucose
  • LDL Cholesterol
  • Physical Activity
  • Sleep Duration
  • Smoking Status

Eligibility Criteria

Sex
ALL
Age
55 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NeoMayor App — BEHAVIORAL
    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.
  • Wearable Device Support — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jun 8, 2026
Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
May 31, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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 support
  • No Intervention: Control Group
    Participants will receive standard health information and continue with their usual healthcare provided by the public health system

Primary Outcome Measure

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

Central Contacts

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