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

2026년 8월 5일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

240

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Control Group
Participants will receive standard health information and continue with their usual healthcare provided by the public health system
실험적: 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).
행동: 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.
다른 이름들:
  • mHealth
  • mobile software
장치: 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.
행동: 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.
다른 이름들:
  • Human Health Assistance

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
기간: 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

2차 결과 측정

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

기타 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Chile

협력자

Agencia Nacional de Investigación y Desarrollo

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 4월 1일

연구 완료 (추정된)

2027년 5월 1일

연구 등록 날짜

최초 제출

2026년 6월 2일

QC 기준을 충족하는 최초 제출

2026년 6월 2일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 5일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Neomayor

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다