Blood Pressure, Body Mass Index, Cardiovascular Health Status, Diet Quality, Fasting Glucose, LDL Cholesterol, Physical Activity, Sleep Duration, Smoking Status, Urinary Albumin-to-Creatinine Ratio
Conditions
Keywords
Cardiovascular Health Index, cardiovascular risk, Life's Essential 8, mhealth, older adults, implementation science, hybrid effectiveness-implementation trial
Brief 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.
Detailed description
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 of 2 months conducted in Chile. That pilot did not assess sustained use beyond the initial period, so no prior data exist on how engagement or adherence evolve over a four-month intervention. This trial follows a Hybrid Type 1 design, the primary aim is confirmatory and evaluates clinical effectiveness on cardiovascular health index; the implementation aim is exploratory and evaluates strategies to support sustained engagement. This distinction is reflected in the statistical analysis plan, where only the primary effectiveness outcome is powered for confirmatory testing. The implementation aim is guided by the RE-AIM framework, focusing on reach, adoption, fidelity, and maintenance. Within the NeoMayor arm, participants are randomized to receive the app with or without a human health coach, and with or without a wearable device. These two implementation support strategies are evaluated through their main effects on engagement, adherence, retention, and maintenance of app use, using the full intervention arm sample. The coach x wearable interaction, and any association between implementation outcomes and clinical outcomes, will be analyzed descriptively and reported as exploratory, given the sample size was not calculated for these comparisons.
Interventions
BEHAVIORALNeoMayor App
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.
DEVICEWearable Device Support
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.
BEHAVIORALHuman Health Coach Support
Participants randomized to coach support will receive monthly contact from a geriatrician to support onboarding, troubleshoot app use, and encourage continued engagement with the app content and challenges. This is an implementation support strategy, not an independent clinical intervention.
Sponsors
University of Chile
Agencia Nacional de Investigación y Desarrollo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Double (Outcomes Assessor and Investigator)
Intervention model description
Participants will be randomized in a 2:1 ratio to either the NeoMayor mHealth intervention or a control group receiving usual care and standard health information. Within the intervention arm, participants will undergo an additional 2x2 factorial randomization to receive the app with or without human health support, and with or without wearable device support. These two factors are implementation support strategies and are not analyzed as separate clinical arms. Randomization will be stratified by recruitment site (urban and rural centers).
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Life's Essential 8 Cardiovascular Health Index (CVHI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cognitive performance | 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. |
| Depression | Baseline and 4 months | Yesavage Geriatric depression scale 15 (scores 0-15) higher is worse |
| Anxiety | Baseline and 4 months | Geriatric Anxiety Inventory (scores 0-20) higher is worse |
| Health-Related Quality of Life | Baseline and 4 months | Health-Related Quality of Life -12 (scores 0-100) higher is better |
| Physical performance | 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) |
| Modifiable dementia risk factors | Baseline and 4 months | LIBRA score (-5.9 a +12.7) higher is worse |
| Urinary albumin-to-creatinine ratio (UACR) | Baseline and 4 months | Spot urine sample. Explored as an association with change in CVHI and cardiovascular risk. |
Countries
Chile
Contacts
CONTACTGeneral coordinator
Outcome results
None listed