Effectiveness of NeoMayor in Improving Cardiovascular Health (NCT07633392) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of NeoMayor in Improving Cardiovascular Health
Chile240 participantsStarted 2026-09-01
Plain-language summary
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.
Who can participate
Age range
55 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing something called NeoMayor and measuring a score called the Life's Essential 8 Cardiovascular Health Index — can you explain what that score covers and whether improving it would be meaningful for my specific situation?
2The trial isn't recruiting yet, so there's no set start date — given where I am right now with my cardiovascular health, does it make sense to wait and see if this trial opens, or should we be starting some form of treatment or lifestyle program now?
3The trial is looking at things like diet, sleep, physical activity, blood pressure, LDL cholesterol, and fasting glucose all together — are there established programs or interventions already available that target these same factors, and how would those compare to waiting for this trial?
4Since this trial is listed as Phase NA, which often applies to behavioral or device studies rather than drug trials, can you help me understand what NeoMayor actually is and what the known safety profile looks like before I consider whether to enroll?
5If this trial does open and I become eligible, what would participation actually involve day-to-day — for example, would I need to change my current medications or routines, and how would that fit with managing my health in the meantime?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)