Effectiveness of NeoMayor in Improving Cardiovascular Health
NEOMAYOR
1 other identifier
interventional
240
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2026
CompletedFirst Posted
Study publicly available on registry
June 8, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
Study Completion
Last participant's last visit for all outcomes
May 1, 2027
June 8, 2026
May 1, 2026
5 months
June 2, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
The primary outcome is the change in the Life's Essential 8 Cardiovascular Health Index (CVHI) from baseline to 4 months. The CVHI is a composite cardiovascular health score ranging from 0 to 100, with higher scores indicating better cardiovascular health status. The index is based on the eight cardiovascular health components defined by the American Heart Association Life's Essential 8 framework, including:Smoking status,Physical activity,Diet quality,Sleep duration,Body mass index (BMI),Blood pressure,LDL cholesterol,Fasting glucose. Each component is standardized according to published scoring algorithms and combined to generate the overall cardiovascular health score. The primary analysis will evaluate the between-group difference in change in CVHI over time.
Baseline and 4 months
Secondary Outcomes (10)
Global cognition
Baseline and 4 months
Attention and cognitive flexibility
Baseline and 4 months
Cognitive processing speed
Baseline and 4 months
Depression
Baseline and 4 months
Anxiety
Baseline and 4 months
- +5 more secondary outcomes
Study Arms (2)
NeoMayor app
EXPERIMENTALParticipants 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 4 months. Participants in this arm will additionally be randomized to receive the intervention with or without wearable device suppor
Control Group
NO INTERVENTIONParticipants will receive standard health information and continue with their usual healthcare provided by the public health system
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital clinico Universidad de Chile. Carlos Lorca Tobar 999
Santiago, Independencia, 8380456, Chile
Hospital de Til til Daniel Moya #100
Tiltil, Chile
Related Publications (2)
Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.
PMID: 35766027BACKGROUNDGutierrez M, Cabello V, SanMartin CD, Mauro J, Musa G, Torres M, San Martin MC, Marquez C, Beltran R, Rogers N, Salech F, Ponce D, Ampuero C, Varas P, Gamboa-Labbe B, Cortes VD, Vega C, Ruiz R, Velasquez J, Vergara R, Behrens MI, More J, Delgado Derio C. An mHealth App (NeoMayor) to Promote Healthy Lifestyles and Brain Health in Older Adults: Design and Validation Study. JMIR Aging. 2025 Oct 1;8:e71936. doi: 10.2196/71936.
PMID: 41032870RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Single (Outcomes Assessor)
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2026
First Posted
June 8, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
June 8, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, 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
De-identified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers.