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NCT Number: NCT07633392

Effectiveness of NeoMayor in Improving Cardiovascular Health

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.

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Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital clinico Universidad de Chile. Carlos Lorca Tobar 999, Santiago, Independencia, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

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

Treatment and study plan

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.

Other names: mhealth, mobile software

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.

Primary outcomes

  1. Change in Life's Essential 8 Cardiovascular Health Index (CVHI)

    Time frame: Baseline and 4 months

    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.

Secondary outcomes

  1. Cognitive performance

    Time frame: Baseline and 4 months

    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.

  2. Depression

    Time frame: Baseline and 4 months

    Yesavage Geriatric depression scale 15 (scores 0-15) higher is worse

  3. Anxiety

    Time frame: Baseline and 4 months

    Geriatric Anxiety Inventory (scores 0-20) higher is worse

  4. Health-Related Quality of Life

    Time frame: Baseline and 4 months

    Health-Related Quality of Life -12 (scores 0-100) higher is better

  5. Physical performance

    Time frame: Baseline and 4 months

    Global performance will be measure by the Short physical performance battery (0-12, higher is worse) and the Balance systems will be assessed by the Mini best Test (0-28, higher is better)

  6. Modifiable dementia risk factors

    Time frame: Baseline and 4 months

    LIBRA score (-5.9 a +12.7) higher is worse

Study contacts

Contact information is provided by the study sponsor or research team.

General coordinator

CONTACT

[email protected]

+56977492730

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Agencia Nacional de Investigación y Desarrollo

Registry information

Official study title

Effectiveness of NeoMayor in Improving Cardiovascular Health Status in Chilean Adults

Acronym: NEOMAYOR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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