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

5. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

240

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control Group
Participants will receive standard health information and continue with their usual healthcare provided by the public health system
Eksperimentell: 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).
Atferdsmessig: 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.
Andre navn:
  • mHealth
  • mobile software
Enhet: 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.
Atferdsmessig: 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.
Andre navn:
  • Human Health Assistance

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cognitive performance
Tidsramme: 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
Tidsramme: Baseline and 4 months
Yesavage Geriatric depression scale 15 (scores 0-15) higher is worse
Baseline and 4 months
Anxiety
Tidsramme: Baseline and 4 months
Geriatric Anxiety Inventory (scores 0-20) higher is worse
Baseline and 4 months
Health-Related Quality of Life
Tidsramme: Baseline and 4 months
Health-Related Quality of Life -12 (scores 0-100) higher is better
Baseline and 4 months
Physical performance
Tidsramme: 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
Tidsramme: Baseline and 4 months
LIBRA score (-5.9 a +12.7) higher is worse
Baseline and 4 months
Urinary albumin-to-creatinine ratio (UACR)
Tidsramme: Baseline and 4 months
Spot urine sample. Explored as an association with change in CVHI and cardiovascular risk.
Baseline and 4 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Engagement
Tidsramme: Continuous over 4 months
Number of app sessions, session frequency, total time in-app
Continuous over 4 months
Adherence
Tidsramme: : Continuous over 4 months
Percentage of prescribed challenges completed; proportion of planned activities completed
: Continuous over 4 months
Retention
Tidsramme: 4 months
Proportion of participants remaining active in the intervention through 4 months
4 months
Maintenance of app use
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Chile

Samarbeidspartnere

Agencia Nacional de Investigación y Desarrollo

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Neomayor

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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