NCT07633392 Effectiveness and Implementation Evaluation of NeoMayor for Improving Cardiovascular Health in Chilean Older Adults

Eligibility & Interventions

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This trial targets 240 participants in total. It began in 2026-10-05 with a primary completion date of 2027-04.

Brief Summary

This study aims to evaluate the effectiveness and implementation 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 NeoMayor improves cardiovascularhealth, measured with the Life's Essential 8 Cardiovascular Health Index (CVHI).Secondary objectives include changes in cognitive performance, depressivesymptoms, anxiety symptoms, quality of life, physical performance, and urinaryalbumin-to-creatinine ratio (UACR). This is a Hybrid Type 1 effectiveness-implementation trial. As an exploratory aim, participants in the NeoMayor arm are further randomized (2x2 factorial) to receivethe app with or without human health coach support, and with or without a wearable device, both used as implementation support strategies. The study will describe engagement, adherence, retention, and maintenance of app use over four months.This aim is hypothesis-generating; the trial is not powered to compare implementation strategies.

Eligibility Criteria

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 MEFO \< 9 * 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

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