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Effectiveness of NeoMayor in Improving Cardiovascular Health in Chilean Older Adults

Study acronym: NEOMAYOR
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Feb 2027 → Apr 2027
See other at-risk trials from University of Chile

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Feb 2027 to Apr 2027v3 Show 5 more changesShow less
    • Interventions: NeoMayor App (Behavioral), Wearable Device Support (Device) to Human Health Coach Support (Behavioral), NeoMayor App (Behavioral), Wearable Device Support (Device)
    • Eligibility criteria revised
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 124 words
    • Study title expanded, about 4 words
  2. Eligibility criteria shortened, about 11 words
    • Secondary endpoints: 10 to 6
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07633392
Lead Sponsor University of Chile
Collaborators: Agencia Nacional de Investigación y Desarrollo
Conditions
(from sponsor)		 Cardiovascular Health Status, Smoking Status, Physical Activity, Diet Quality, Sleep Duration, Body Mass Index, Blood Pressure, LDL Cholesterol +2 more
Related terms Motor Activity
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov