Effectiveness of NeoMayor in Improving Cardiovascular Health in Chilean Older Adults (NEOMAYOR)
A Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial of NeoMayor, a Mobile Health Intervention to Improve Cardiovascular Health in Chilean Older Adults
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: General coordinator
- Número de teléfono: +56977492730
- Correo electrónico: coordinacionmayores@gmail.com
Ubicaciones de estudio
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Tiltil, Chile
- Hospital de Til til Daniel Moya #100
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Independencia
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Santiago, Independencia, Chile, 8380456
- Hospital clinico Universidad de Chile. Carlos Lorca Tobar 999
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control Group
Participants will receive standard health information and continue with their usual healthcare provided by the public health system
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Experimental: NeoMayor app
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).
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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.
Otros nombres:
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
Periodo de tiempo: Baseline and 4 months
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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.
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Baseline and 4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cognitive performance
Periodo de tiempo: Baseline and 4 months
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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.
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Baseline and 4 months
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Depression
Periodo de tiempo: Baseline and 4 months
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Yesavage Geriatric depression scale 15 (scores 0-15) higher is worse
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Baseline and 4 months
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Anxiety
Periodo de tiempo: Baseline and 4 months
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Geriatric Anxiety Inventory (scores 0-20) higher is worse
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Baseline and 4 months
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Health-Related Quality of Life
Periodo de tiempo: Baseline and 4 months
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Health-Related Quality of Life -12 (scores 0-100) higher is better
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Baseline and 4 months
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Physical performance
Periodo de tiempo: Baseline and 4 months
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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)
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Baseline and 4 months
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Modifiable dementia risk factors
Periodo de tiempo: Baseline and 4 months
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LIBRA score (-5.9 a +12.7) higher is worse
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Baseline and 4 months
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Urinary albumin-to-creatinine ratio (UACR)
Periodo de tiempo: Baseline and 4 months
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Spot urine sample.
Explored as an association with change in CVHI and cardiovascular risk.
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Baseline and 4 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Engagement
Periodo de tiempo: Continuous over 4 months
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Number of app sessions, session frequency, total time in-app
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Continuous over 4 months
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Adherence
Periodo de tiempo: : Continuous over 4 months
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Percentage of prescribed challenges completed; proportion of planned activities completed
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: Continuous over 4 months
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Retention
Periodo de tiempo: 4 months
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Proportion of participants remaining active in the intervention through 4 months
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4 months
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Maintenance of app use
Periodo de tiempo: Month 1 and Month 4
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App use frequency in the final month compared with the first month.
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Month 1 and Month 4
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Reach, adoption, and fidelity
Periodo de tiempo: Throughout the 4-month intervention
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Assessed through app usage records and semi-structured interviews with a purposive sample of participants and healthcare staff
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Throughout the 4-month intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Gutierrez 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Neomayor
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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