Cardiovascular Health StatusNEOMAYORNCT07633392
Effectiveness and Implementation Evaluation of NeoMayor for Improving Cardiovascular Health in Chilean Older Adults
A study testing NeoMayor App, Wearable Device Support and Human Health Coach Support in people with Cardiovascular Health Status and Smoking Status, run by University of Chile at 2 sites in Chile.
Trial summary
This study aims to evaluate the effectiveness and implementation of NeoMayor, a mobile health (mHealth) intervention designed to improve cardiovascular health among older adults at elevated cardiovascular risk in Chile. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Cardiovascular Health Status, Smoking Status, Physical Activity
- What is being tested?
- NeoMayor App, Wearable Device Support and Human Health Coach Support
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesChile
- Study dates
- 5 Oct 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chile2 sites, 2 recruiting
- Recruiting
Hospital clinico Universidad de Chile. Carlos Lorca Tobar 999
Santiago, Independencia, 8380456
Johana Santander, Neomayor Santiago coordinator, +56957539840, coordinacionmayores@gmail.com
Melissa Torres, Neomayor Coordinator, +56967890671, mtorrest@hcuch.cl
- Recruiting
Hospital de Til til Daniel Moya #100
Tiltil
Anita Gil, coordinador neomayor tiltil, +56962341081, neomayor.tiltil@gmail.com
Melissa Torres, General coordinator, +56967890671, mtorrest@hcuch.cl
About this study
Official title: 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 and implementation 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.
Read more
The primary objective is to determine whether NeoMayor improves cardiovascularhealth, measured with the Life's Essential 8 Cardiovascular Health Index (CVHI).Secondary objectives include changes in cognitive performance, depressivesymptoms, anxiety symptoms, quality of life, physical performance, and urinaryalbumin-to-creatinine ratio (UACR).
This is a Hybrid Type 1 effectiveness-implementation trial. As an exploratory aim, participants in the NeoMayor arm are further randomized (2x2 factorial) to receivethe app with or without human health coach support, and with or without a wearable device, both used as implementation support strategies. The study will describe engagement, adherence, retention, and maintenance of app use over four months.This aim is hypothesis-generating; the trial is not powered to compare implementation strategies.
Read the detailed description
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.
- Conditions
- Cardiovascular Health Status, Smoking Status, Physical Activity, Diet Quality, Sleep Duration, Body Mass Index
- Being tested
- NeoMayor App, Wearable Device Support, Human Health Coach Support
- Keywords
- Cardiovascular Health Index, cardiovascular risk, Life's Essential 8, mhealth, older adults, implementation science, hybrid effectiveness-implementation trial
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoMayor AppBehavioural
Also called mhealth, mobile software
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.
Wearable Device SupportDevice
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.
Human Health Coach SupportBehavioural
Also called Human Health Assistance
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.
| Study group | Role | What they receive |
|---|---|---|
| NeoMayor app | Experimental | 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). Receives: Behavioral: NeoMayor App; Device: Wearable Device Support; Behavioral: Human Health Coach Support |
| Control Group | No intervention | Participants will receive standard health information and continue with their usual healthcare provided by the public health system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
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.
Measured: Baseline and 4 months
Secondary outcomes (7)
Cognitive performance
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.
Measured: Baseline and 4 months
Depression
Yesavage Geriatric depression scale 15 (scores 0-15) higher is worse
Measured: Baseline and 4 months
Anxiety
Geriatric Anxiety Inventory (scores 0-20) higher is worse
Measured: Baseline and 4 months
Health-Related Quality of Life
Health-Related Quality of Life -12 (scores 0-100) higher is better
Measured: Baseline and 4 months
Physical performance
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)
Measured: Baseline and 4 months
Modifiable dementia risk factors
LIBRA score (-5.9 a +12.7) higher is worse
Measured: Baseline and 4 months
Urinary albumin-to-creatinine ratio (UACR)
Spot urine sample. Explored as an association with change in CVHI and cardiovascular risk.
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start5 Oct 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Health StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 2:1 ratio to either the NeoMayor mHealth intervention or a control group receiving usual care and standard health information. Within the intervention arm, participants will undergo an additional 2x2 factorial randomization to receive the app with or without health coach support, and with or without wearable device support. These two factors are implementation support strategies and are not analyzed as separate clinical arms. Randomization will be stratified by recruitment site (urban and rural centers).Participants will be considered enrolled once they have signed the informed consent form, met all eligibility criteria at the baseline evaluation, and been randomized. Individuals who sign the informed consent form but do not meet the eligibility criteria will be classified as screen failures and will not be counted as enrolled. The intervention starts after randomization, up to approximately two weeks after the baseline evaluation.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633392
- Sponsor's protocol ID
- Neomayor
- Acronym
- NEOMAYOR
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers.
Publications
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.
PubMed 35766027Gutierrez 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.
PubMed 41032870
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid Type 1 Effectiveness-Implementation Randomized Controlled Trial of NeoMayor, a Mobile Health Intervention to Improve Cardiovascular Health in Chilean Older Adults
- ClinicalTrials.gov ID
- NCT07633392
- Acronym / sponsor ID
- NEOMAYOR / Neomayor
- Conditions
- Cardiovascular Health Status, Smoking Status, Physical Activity, Diet Quality, Sleep Duration, Body Mass Index
- Keywords
- Cardiovascular Health Index, cardiovascular risk, Life's Essential 8, mhealth, older adults, implementation science, hybrid effectiveness-implementation trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness and implementation 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 NeoMayor improves cardiovascularhealth, measured with the Life's Essential 8 Cardiovascular Health Index (CVHI).Secondary objectives include changes in cognitive performance, depressivesymptoms, anxiety symptoms, quality of life, physical performance, and urinaryalbumin-to-creatinine ratio (UACR).
This is a Hybrid Type 1 effectiveness-implementation trial. As an exploratory aim, participants in the NeoMayor arm are further randomized (2x2 factorial) to receivethe app with or without human health coach support, and with or without a wearable device, both used as implementation support strategies. The study will describe engagement, adherence, retention, and maintenance of app use over four months.This aim is hypothesis-generating; the trial is not powered to compare implementation strategies.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 2:1 ratio to either the NeoMayor mHealth intervention or a control group receiving usual care and standard health information. Within the intervention arm, participants will undergo an additional 2x2 factorial randomization to receive the app with or without health coach support, and with or without wearable device support. These two factors are implementation support strategies and are not analyzed as separate clinical arms. Randomization will be stratified by recruitment site (urban and rural centers).Participants will be considered enrolled once they have signed the informed consent form, met all eligibility criteria at the baseline evaluation, and been randomized. Individuals who sign the informed consent form but do not meet the eligibility criteria will be classified as screen failures and will not be counted as enrolled. The intervention starts after randomization, up to approximately two weeks after the baseline evaluation.
| Arm | Type | Receives |
|---|---|---|
| NeoMayor app | Experimental | Behavioral: NeoMayor App, Device: Wearable Device Support, Behavioral: Human Health Coach SupportParticipants 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). |
| Control Group | No intervention | –Participants will receive standard health information and continue with their usual healthcare provided by the public health system |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoMayor AppAlso: mhealth, mobile softwareNeoMayor 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. | Behavioural | NeoMayor app |
| Wearable Device SupportParticipants 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. | Device | NeoMayor app |
| Human Health Coach SupportAlso: Human Health AssistanceParticipants 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. | Behavioural | NeoMayor app |
Primary outcome
Change in Life's Essential 8 Cardiovascular Health Index (CVHI)
Time frame: 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.
7 secondary outcomes
Cognitive performance
Time frame: Baseline and 4 months
Depression
Time frame: Baseline and 4 months
Anxiety
Time frame: Baseline and 4 months
Health-Related Quality of Life
Time frame: Baseline and 4 months
Physical performance
Time frame: Baseline and 4 months
Modifiable dementia risk factors
Time frame: Baseline and 4 months
Urinary albumin-to-creatinine ratio (UACR)
Time frame: Baseline and 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 35766027Lloyd-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.
- Results publication: PubMed 41032870Gutierrez 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoMayor App, Wearable Device Support and Human Health Coach Support in people with Cardiovascular Health Status and Smoking Status, run by University of Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact General coordinator (+56977492730, coordinacionmayores@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Life's Essential 8 Cardiovascular Health Index (CVHI) (time frame: Baseline and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07633392, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.