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Effectiveness of NeoMayor in Improving Cardiovascular Health in Chilean Older Adults (NEOMAYOR)

5 août 2026 mis à jour par: University of Chile

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

240

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chili
      • Tiltil, Chili
        • Hospital de Til til Daniel Moya #100
    • Independencia
      • Santiago, Independencia, Chili, 8380456
        • Hospital clinico Universidad de Chile. Carlos Lorca Tobar 999

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Control Group
Participants will receive standard health information and continue with their usual healthcare provided by the public health system
Expérimental: 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).
Comportemental: NeoMayor 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.
Autres noms:
  • mhealth
  • mobile software
Dispositif: Wearable 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.
Comportemental: Human 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.
Autres noms:
  • Human Health Assistance

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
Délai: 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.
Baseline and 4 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cognitive performance
Délai: 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.
Baseline and 4 months
Depression
Délai: Baseline and 4 months
Yesavage Geriatric depression scale 15 (scores 0-15) higher is worse
Baseline and 4 months
Anxiety
Délai: Baseline and 4 months
Geriatric Anxiety Inventory (scores 0-20) higher is worse
Baseline and 4 months
Health-Related Quality of Life
Délai: Baseline and 4 months
Health-Related Quality of Life -12 (scores 0-100) higher is better
Baseline and 4 months
Physical performance
Délai: 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)
Baseline and 4 months
Modifiable dementia risk factors
Délai: Baseline and 4 months
LIBRA score (-5.9 a +12.7) higher is worse
Baseline and 4 months
Urinary albumin-to-creatinine ratio (UACR)
Délai: Baseline and 4 months
Spot urine sample. Explored as an association with change in CVHI and cardiovascular risk.
Baseline and 4 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Engagement
Délai: Continuous over 4 months
Number of app sessions, session frequency, total time in-app
Continuous over 4 months
Adherence
Délai: : Continuous over 4 months
Percentage of prescribed challenges completed; proportion of planned activities completed
: Continuous over 4 months
Retention
Délai: 4 months
Proportion of participants remaining active in the intervention through 4 months
4 months
Maintenance of app use
Délai: Month 1 and Month 4
App use frequency in the final month compared with the first month.
Month 1 and Month 4
Reach, adoption, and fidelity
Délai: Throughout the 4-month intervention
Assessed through app usage records and semi-structured interviews with a purposive sample of participants and healthcare staff
Throughout the 4-month intervention

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Chile

Collaborateurs

Agencia Nacional de Investigación y Desarrollo

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

1 avril 2027

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

2 juin 2026

Première soumission répondant aux critères de contrôle qualité

2 juin 2026

Première publication (Réel)

8 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 août 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Neomayor

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers.

Délai de partage IPD

Data will be available beginning 12 months after the completion of the study and for a period of 5 years thereafter

Critères d'accès au partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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