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NCT07633392
Effectiveness of NeoMayor in Improving Cardiovascular Health
Conditions: Cardiovascular Health Status, Smoking Status, Physical Activity, Diet Quality, Sleep Duration, Body Mass Index, Blood Pressure, LDL Cholesterol, Fasting Glucose
Sex: All
Ages: 55 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 240
Sponsor: University of Chile
Location: Hospital clinico Universidad de Chile. Carlos Lorca Tobar 999 Santiago Independencia
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.
Eligibility 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 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
Participants meeting any of the following criteria will be excluded:
Dementia defined as a socre 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.
Source: ClinicalTrials.gov (NCT07633392). StuddyBuddy aggregates publicly available trial information.