An interventional study of NeoMayor App and Wearable Device Support in Cardiovascular Health Status, Smoking Status and Physical Activity, sponsored by University of Chile. Recruiting at 2 sites in Chile. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by University of Chile · Not applicable, Interventional, and Prevention
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 240 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →University of Chile is the lead sponsor of 194 studies on the registry; 38 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive access to the NeoMayor mobile health application designed to promote healthy lifestyle behaviors through structured behavioral challenges targeting physical activity, diet, sleep, and mental well-being during four months. Within this arm, participants are further randomized to receive the app with or without human health coach support, and with or without wearable device support (2x2 factorial).
Behavioral: NeoMayor App · Device: Wearable Device Support · Behavioral: Human Health Coach Support
Participants will receive standard health information and continue with their usual healthcare provided by the public health system
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.
Also known as: mhealth, mobile software
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.
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.
Also known as: Human Health Assistance
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
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.
Time frame: Baseline and 4 months
Cognitive performance
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.
Time frame: Baseline and 4 months
Depression
Yesavage Geriatric depression scale 15 (scores 0-15) higher is worse
Time frame: Baseline and 4 months
Anxiety
Geriatric Anxiety Inventory (scores 0-20) higher is worse
Time frame: Baseline and 4 months
Health-Related Quality of Life
Health-Related Quality of Life -12 (scores 0-100) higher is better
Time frame: Baseline and 4 months
Physical performance
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)
Time frame: Baseline and 4 months
Modifiable dementia risk factors
LIBRA score (-5.9 a +12.7) higher is worse
Time frame: Baseline and 4 months
Urinary albumin-to-creatinine ratio (UACR)
Spot urine sample. Explored as an association with change in CVHI and cardiovascular risk.
Time frame: Baseline and 4 months
Engagement
Number of app sessions, session frequency, total time in-app
Time frame: Continuous over 4 months
Adherence
Percentage of prescribed challenges completed; proportion of planned activities completed
Time frame: Continuous over 4 months
Retention
Proportion of participants remaining active in the intervention through 4 months
Time frame: 4 months
Maintenance of app use
App use frequency in the final month compared with the first month.
Time frame: Month 1 and Month 4
Reach, adoption, and fidelity
Assessed through app usage records and semi-structured interviews with a purposive sample of participants and healthcare staff
Time frame: Throughout the 4-month intervention
Plan to share: Yes — De-identified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available beginning 12 months after the completion of the study and for a period of 5 years thereafter
Access criteria: Data will be shared with researchers who provide a methodologically sound proposal and have institutional review board (IRB) approval. Requests should be directed to cdelgado@uchile.cl. To gain access, data requestors will need to sign a data access agreement
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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