Cardiac EventVWCRNCT05897710
Virtual World-Based Cardiac Rehabilitation
A study testing Virtual World-Based Cardiac Rehabilitation (VWCR) and Center-Based Cardiac Rehabilitation (CBCR) in people with Cardiac Event and Telemedicine, run by Mayo Clinic at 1 site in United States.
Trial summary
The proposed trial is a multiphase, multicenter, non-inferiority, hybrid type 1 effectiveness, randomized controlled trial to test an innovative virtual world-based cardiac rehabilitation (CR) program, "Destination Cardiac Rehab". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Event, Telemedicine, Cardiovascular Diseases
- What is being tested?
- Virtual World-Based Cardiac Rehabilitation (VWCR) and Center-Based Cardiac Rehabilitation (CBCR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,881 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Indication for CR according to Centers for Medicare \& Medicaid Services (CMS) guidelines: Myocardial infarction within the preceding 12 months; Coronary artery bypass surgery; Current stable angina (chest pain); Heart valve repair or replacement; Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; Heart or heart-lung transplant; Stable chronic heart failure
- Aged ≥18 years
- Basic Internet navigation skills
- Active email address
Who cannot join
- High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification (e.g., sudden cardiac arrest survivor)
- Receiving continuous inotropic support
- Presence of a mechanical circulatory support device
- Decompensated heart failure
- Symptomatic valvular heart disease
- Uncontrolled angina
Show all 10Show fewer
- Presence of hemodynamically unstable dysrhythmias (e.g., ventricular tachycardia) given safety concern of unsupervised exercise20
- Pregnant (due to associated hormonal and weight changes)
- Non-English-speaking
- Visual/hearing impairment or mental disability that would preclude independent use of the VW platform
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual World-Based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients
The proposed trial is a multiphase, multicenter, non-inferiority, hybrid type 1 effectiveness, randomized controlled trial to test an innovative virtual world-based cardiac rehabilitation (CR) program, "Destination Cardiac Rehab". The primary objectives of this study are to assess the efficacy and adherence of "Destination Cardiac Rehab" compared to traditional center-based CR.
Read the detailed description
The proposed virtual world-based cardiac rehabilitation (VWCR) program provides a novel home-based delivery method of a CR program to address several barriers to care associated with traditional center-based CR (CBCR). This 2-arm, randomized controlled trial (RCT) will rigorously assess adherence and efficacy of VWCR compared to CBCR in a 12-week (36-session) intervention that includes patient education, self-monitoring of physical activity and blood pressure, social support, and weekly telehealth visits with a CR nurse and exercise physiologist. Patients with a CR eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. We hypothesize that the VWCR, known as "Destination Cardiac Rehab" will be non-inferior to CBCR as assessed by improvement in cardiovascular health and adherence to CR sessions.
- Conditions
- Cardiac Event, Telemedicine, Cardiovascular Diseases
- Being tested
- Virtual World-Based Cardiac Rehabilitation (VWCR), Center-Based Cardiac Rehabilitation (CBCR)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual World-Based Cardiac Rehabilitation (VWCR)Other
Also called Destination Cardiac Rehab
12-week virtual world technology-based program via Second Life platform. Weekly virtual visits with nurse coach and exercise physiologist, weekly education sessions, and social support group discussions within the virtual world environment.
Center-Based Cardiac Rehabilitation (CBCR)Other
Traditional 12-week in-person cardiac rehabilitation program; standard of care at participant's cardiac rehabilitation facility
| Study group | Role | What they receive |
|---|---|---|
| Center-Based Cardiac Rehab (CBCR) | Active comparator | Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program. Receives: Other: Center-Based Cardiac Rehabilitation (CBCR) |
| Virtual World-Based Cardiac Rehab (VWCR) | Experimental | Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program. Receives: Other: Virtual World-Based Cardiac Rehabilitation (VWCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life's Essential 8 component: Self-reported healthy diet
Changes from baseline in healthy diet using the Mediterranean Eating Patterns for Americans (MEPA), a 16-item questionnaire evaluating accordance with a Mediterranean-like diet pattern
Measured: Baseline, 3 months, and 6 months post-randomization
Life's Essential 8 component: Self-reported physical activity
Changes from baseline in physical activity using the International Physical Activity Questionnaire (IPAQ), a 12-item questionnaire classifying physical activity as "low," "moderate," or "high" intensity physical activity (minutes/day) over the prior week
Measured: Baseline, 3 months, and 6 months post-randomization
Life's Essential 8 component: Self-Reported smoking status
Changes from baseline in smoking status using the National Health and Nutrition Examination Survey-Smoking-Cigarette Use Questionnaire (NHANES-SMQ), evaluating current and past smoking habits
Measured: Baseline, 3 months, and 6 months post-randomization
Life's Essential 8 component: Sleep Quality
Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI).
Measured: Baseline, 3 months, and 6 months post-randomization
Life's Essential 8 component: Body Mass Index (BMI)
Changes from baseline in BMI as calculated with weight (kg) and height (m), reported as kg/m^2
Measured: Baseline, 3 months, and 6 months post-randomization
Life's Essential 8 component: Cholesterol
Changes from baseline in Non-HDL Cholesterol levels reported as mg/dL
Measured: Baseline, 3 months, and 6 months post-randomization
Life's Essential 8 component: Blood Glucose
Changes from baseline in Hemoglobin A1c (percent) and fasting blood glucose (mg/dL)
Measured: Baseline, 3 months, and 6 months post-randomization
Life's Essential 8 component: Blood Pressure
Changes from baseline in systolic and diastolic blood pressure measurements; average of three sitting readings in mmHg
Measured: Baseline, 3 months, and 6 months post-randomization
Life's Essential 8 composite score: Cardiovascular health
Changes from baseline in Life's Essential 8 score. Life's Essential 8 composite score is determined as a composite of all components by calculating an unweighted average score on a scale of 0 to 100 points. An overall cardiovascular health score (Life's Essential 8 score) will be considered high (80 to 100 points), moderate (50 to 79 points) or low for (0 to 49 points).
Measured: Baseline, 3 months, and 6 months post-randomization
Number of sessions attended by participants
Optimal adherence defined as completion of 70% or more of weekly visits (in-person or virtual). Attendance measured by CR staff for control group, and by VWCR web administrators, Exercise Physiologists, and Nurse Coaches in the VWCR arm.
Measured: Baseline through 12-week program
Secondary outcomes (10)
MACE (Major Adverse Cardiovascular Events) 3 months post-randomization
MACE (Major Adverse Cardiovascular Events): CV-related hospital readmissions; CV and all-cause mortality
Measured: 3 months and 6 months post-randomization
Exercise Sessions
Self-reported number of self-directed exercise sessions per week, confirmed by Fitbit activity tracker data.
Measured: Baseline through 12-week (36 session) cardiac rehabilitation program
Functional Capacity
Six-Minute walk test, evaluating blood pressure, oxygen saturation, and pulse after walking for 6 minutes at a normal pace
Measured: Baseline, 3 months, and 6 months post-randomization
Health-related quality of life
Changes from baseline in health-related quality of life using the Short Form [SF]-12 Health Survey, a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 consists of 12-items and 8 subdomains. Each item of the questionnaire has response categories which vary from 2- to 6-point scales and raw scores for items ranging from 1 to 6. The raw scores are summated and linearly transformed into 0-100 scale with a higher score indicating better health status.
Measured: Baseline, 3 months, and 6 months post-randomization
Physical Activity Self-efficacy
Changes from baseline in physical activity self-efficacy measured by the Exercise Confidence Survey scale to assess the participant's confidence in their ability to exercise when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A higher total sum indicates higher self-efficacy for physical activity.
Measured: Baseline, 3 months, and 6 months post-randomization
Physical Activity Self-regulation
Changes from baseline in physical activity self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to increase their step count or physical activity levels. Items are measured on a five-point scale from 1 (never) to 5 (repeatedly). Higher scores indicate more self-regulation.
Measured: Baseline, 3 months, and 6 months post-randomization
Physical Activity Social Support
Changes from baseline in physical activity social support using the Social Support for Exercise Survey scale that asks participants how much encouragement they received to increase physical activity on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for physical activity.
Measured: Baseline, 3 months, and 6 months post-randomization
Diet Self-efficacy
Changes from baseline in diet self-efficacy measured the Diet Confidence Survey scale to assess the participant's confidence in their ability to maintain a healthy diet when faced with common barriers. 12 items are assessed, each on a 5-point scale ranging from 1 to 5. A higher total sum indicates higher self-efficacy for healthy eating.
Measured: Baseline, 3 months, and 6 months post-randomization
Diet Self-regulation
Changes from baseline in diet self-regulation measured by the Health Beliefs Survey to assess strategies used in the past 3 months to eat healthier foods. Items are measured on a five-point scale from 1 (never) to 5 (repeatedly). Higher scores indicate more use of self-regulation strategies to promote healthy eating.
Measured: Baseline, 3 months, and 6 months post-randomization
Diet Social Support
Changes from baseline in diet social support using the Social Support for Eating Habits Survey scale that asks participants how much encouragement they received to eat healthier on a five-point scale from 1 (never) to 5 (very often). Higher scores indicate more social support for healthy eating.
Measured: Baseline, 3 months, and 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start7 Mar 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,881 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of California, Irvine, University of Mississippi Medical Center
- Responsible party
- Principal investigator, LaPrincess C. Brewer, Mayo Clinic
- Investigators
- LaPrincess Brewer, M.D., M.P.H., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897710
- Sponsor's protocol ID
- 22-011357
- Acronym
- VWCR
- Status last verified
- Feb 2026
- First submitted
- 5 May 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brewer LC, Abraham H, Clark D 3rd, Echols M, Hall M, Hodgman K, Kaihoi B, Kopecky S, Krogman A, Leth S, Malik S, Marsteller J, Mathews L, Scales R, Schulte P, Shultz A, Taylor B, Thomas R, Wong N, Olson T. Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial. J Am Heart Assoc. 2023 Dec 5;12(23):e030883. doi: 10.1161/JAHA.123.030883. Epub 2023 Nov 28.
PubMed 38014699
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual World-Based Cardiac Rehabilitation to Improve Cardiovascular Health and Outcomes Among Cardiac Patients
- ClinicalTrials.gov ID
- NCT05897710
- Acronym / sponsor ID
- VWCR / 22-011357
- Conditions
- Cardiac Event, Telemedicine, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,881 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of California, Irvine, University of Mississippi Medical Center
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 9 Jun 2023 (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.
The proposed trial is a multiphase, multicenter, non-inferiority, hybrid type 1 effectiveness, randomized controlled trial to test an innovative virtual world-based cardiac rehabilitation (CR) program, "Destination Cardiac Rehab". The primary objectives of this study are to assess the efficacy and adherence of "Destination Cardiac Rehab" compared to traditional center-based CR.
Detailed description
The proposed virtual world-based cardiac rehabilitation (VWCR) program provides a novel home-based delivery method of a CR program to address several barriers to care associated with traditional center-based CR (CBCR). This 2-arm, randomized controlled trial (RCT) will rigorously assess adherence and efficacy of VWCR compared to CBCR in a 12-week (36-session) intervention that includes patient education, self-monitoring of physical activity and blood pressure, social support, and weekly telehealth visits with a CR nurse and exercise physiologist. Patients with a CR eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. We hypothesize that the VWCR, known as "Destination Cardiac Rehab" will be non-inferior to CBCR as assessed by improvement in cardiovascular health and adherence to CR sessions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Center-Based Cardiac Rehab (CBCR) | Active comparator | Other: Center-Based Cardiac Rehabilitation (CBCR)Standard of care for participants' center-based cardiac rehabilitation program. Traditional 12-week, in-person program. |
| Virtual World-Based Cardiac Rehab (VWCR) | Experimental | Other: Virtual World-Based Cardiac Rehabilitation (VWCR)Telehealth delivery of cardiac rehabilitation via Second Life virtual world platform. 12-week, home-based program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indication for CR according to Centers for Medicare \& Medicaid Services (CMS) guidelines: Myocardial infarction within the preceding 12 months; Coronary artery bypass surgery; Current stable angina (chest pain); Heart valve repair or replacement; Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; Heart or heart-lung transplant; Stable chronic heart failure
- Aged ≥18 years
- Basic Internet navigation skills
- Active email address
Key exclusion criteria (10 listed)
- High risk patients according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) risk stratification (e.g., sudden cardiac arrest survivor)
- Receiving continuous inotropic support
- Presence of a mechanical circulatory support device
- Decompensated heart failure
- Symptomatic valvular heart disease
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 |
|---|---|---|
| Virtual World-Based Cardiac Rehabilitation (VWCR)Also: Destination Cardiac Rehab12-week virtual world technology-based program via Second Life platform. Weekly virtual visits with nurse coach and exercise physiologist, weekly education sessions, and social support group discussions within the virtual world environment. | Other | Virtual World-Based Cardiac Rehab (VWCR) |
| Center-Based Cardiac Rehabilitation (CBCR)Traditional 12-week in-person cardiac rehabilitation program; standard of care at participant's cardiac rehabilitation facility | Other | Center-Based Cardiac Rehab (CBCR) |
Primary outcome
Life's Essential 8 component: Self-reported healthy diet
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in healthy diet using the Mediterranean Eating Patterns for Americans (MEPA), a 16-item questionnaire evaluating accordance with a Mediterranean-like diet pattern
Life's Essential 8 component: Self-reported physical activity
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in physical activity using the International Physical Activity Questionnaire (IPAQ), a 12-item questionnaire classifying physical activity as "low," "moderate," or "high" intensity physical activity (minutes/day) over the prior week
Life's Essential 8 component: Self-Reported smoking status
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in smoking status using the National Health and Nutrition Examination Survey-Smoking-Cigarette Use Questionnaire (NHANES-SMQ), evaluating current and past smoking habits
Life's Essential 8 component: Sleep Quality
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in sleep quality (number of hours of sleep nightly) using the Pittsburg Sleep Quality Index (PSQI).
Life's Essential 8 component: Body Mass Index (BMI)
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in BMI as calculated with weight (kg) and height (m), reported as kg/m^2
Life's Essential 8 component: Cholesterol
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in Non-HDL Cholesterol levels reported as mg/dL
Life's Essential 8 component: Blood Glucose
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in Hemoglobin A1c (percent) and fasting blood glucose (mg/dL)
Life's Essential 8 component: Blood Pressure
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in systolic and diastolic blood pressure measurements; average of three sitting readings in mmHg
Life's Essential 8 composite score: Cardiovascular health
Time frame: Baseline, 3 months, and 6 months post-randomization
Changes from baseline in Life's Essential 8 score. Life's Essential 8 composite score is determined as a composite of all components by calculating an unweighted average score on a scale of 0 to 100 points. An overall cardiovascular health score (Life's Essential 8 score) will be considered high (80 to 100 points), moderate (50 to 79 points) or low for (0 to 49 points).
Number of sessions attended by participants
Time frame: Baseline through 12-week program
Optimal adherence defined as completion of 70% or more of weekly visits (in-person or virtual). Attendance measured by CR staff for control group, and by VWCR web administrators, Exercise Physiologists, and Nurse Coaches in the VWCR arm.
10 secondary outcomes
MACE (Major Adverse Cardiovascular Events) 3 months post-randomization
Time frame: 3 months and 6 months post-randomization
Exercise Sessions
Time frame: Baseline through 12-week (36 session) cardiac rehabilitation program
Functional Capacity
Time frame: Baseline, 3 months, and 6 months post-randomization
Health-related quality of life
Time frame: Baseline, 3 months, and 6 months post-randomization
Physical Activity Self-efficacy
Time frame: Baseline, 3 months, and 6 months post-randomization
Physical Activity Self-regulation
Time frame: Baseline, 3 months, and 6 months post-randomization
Physical Activity Social Support
Time frame: Baseline, 3 months, and 6 months post-randomization
Diet Self-efficacy
Time frame: Baseline, 3 months, and 6 months post-randomization
Diet Self-regulation
Time frame: Baseline, 3 months, and 6 months post-randomization
Diet Social Support
Time frame: Baseline, 3 months, and 6 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 38014699Brewer LC, Abraham H, Clark D 3rd, Echols M, Hall M, Hodgman K, Kaihoi B, Kopecky S, Krogman A, Leth S, Malik S, Marsteller J, Mathews L, Scales R, Schulte P, Shultz A, Taylor B, Thomas R, Wong N, Olson T. Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial. J Am Heart Assoc. 2023 Dec 5;12(23):e030883. doi: 10.1161/JAHA.123.030883. Epub 2023 Nov 28.
- Individual participant dataSharing planned: No
Related trials for Cardiac Event
Recruiting
CCTA-Based vs CAG-Based CABG: A Multicenter Pragmatic Non-Inferiority Trial
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingObservational study
Geographic Mismatch as A Predictor of Short-Term Major Adverse Cardiovascular Events Following Long Coronary Stent Implantation
Geographic Mismatch, Short-Term
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. This study is not recruiting at the moment.
LaPrincess Brewer, M.D., M.P.H. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual World-Based Cardiac Rehabilitation (VWCR) and Center-Based Cardiac Rehabilitation (CBCR) in people with Cardiac Event and Telemedicine, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life's Essential 8 component: Self-reported healthy diet (time frame: Baseline, 3 months, and 6 months post-randomization). The study lists 10 primary outcomes in all. 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 NCT05897710, which also lists 1 linked publication.
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 27 Feb 2026.