Cardiovascular DiseasesNCT03897426
Image Based Mobile System for Dietary Assessment and Coaching
A study testing Mediterranean Diet - Remote Coaching using a Mobile App in people with Cardiovascular Diseases, run by Vibrent Health.
Trial summary
Vignet partnered with The George Washington University Hospital to conduct a randomized control trial (RCT) with to evaluate the system's potential to improve health outcomes for patients with CVD. Results from the RCT have the potential to be applied to patients in other chronic disease contexts. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Mediterranean Diet - Remote Coaching using a Mobile App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2016to 31 Aug 2017
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consecutive patients with ongoing cardiology care with a cardiologist based at the GWU MFA and are expected to remain in the care of that cardiologist for at least 6 months.
- Patients must own their own Android- or Apple iOS-based smartphone with a data plan.
- Patients must give informed consent.
- English language requirement.
- At least 5th grade literacy level as assessed with Rapid Estimate of Adult Literacy in Medicine (REALM).[ ]
- Patients must demonstrate an ability to download and install the Vignet FitNinja app.
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- Patient must be at least 18 years of age.
- Patient with evidence of prior acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, ischemic non-embolic stroke/TIA, or peripheral artery disease presumed to be of atherosclerotic origin.
- Patient is on optimal medical therapy as determined by the primary cardiologist at time of enrollment.
Who cannot join
- Clinical instability at time of enrollment.
- Co-morbid medical disease that would preclude ability to participate in a nutrition intervention study (e.g., digestive disease with fat intolerance, life expectancy less than 5 years, severe neurologic, psychiatric or endocrine abnormalities).
- Immunodeficiency or HIV-positive status.
- Illegal drug use, alcoholism or daily alcohol intake >80 g/d.
- BMI>40 kg/m2.
- Inability or unwillingness to change dietary habits as predicted by the Prochaska and DiClemente stages of change model.[ ]
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- Inability or unwillingness to adhere to a Mediterranean diet (e.g., religious/moral reasons, disorders or chewing or swallowing).
- Allergies to major components of the Mediterranean diet (i.e., nuts, olive oil).
- Participation in any drug trial or use of any investigational drug within the past one year.
- Patients who are institutionalized, lack autonomy, are non-ambulatory, lack a stable address, or have a history of missing more than one appointment in the past 6 months.
- Patients with an acute infection or inflammation (e.g., pneumonia) in the past 3 months.
- Pregnancy.
About this study
Vignet partnered with The George Washington University Hospital to conduct a randomized control trial (RCT) with to evaluate the system's potential to improve health outcomes for patients with CVD. Results from the RCT have the potential to be applied to patients in other chronic disease contexts.
Read the detailed description
84 million American adults (>1 in 3) have cardiovascular disease, and cardiovascular disease accounts for 1 of every 3 deaths in the United States and has been the number one cause of deaths in every year since 1918. In addition, strokes, heart attacks, and uncontrolled hypertension are sources of significant disability. However, with control of known cardiovascular risk factors (i.e., smoking, body mass index, physical activity, healthy diet, total cholesterol, blood pressure, fasting plasma glucose), the risk of developing cardiovascular disease is markedly reduced. The most uncontrolled risk factor of these seven metrics for cardiovascular health amongst US adults is healthy dietary behaviors. 73 percent of Americans have a poor diet, and <1 percent have an ideal diet. No other metric of cardiovascular risk comes close - by comparison, the second worst metric is body mass index for which 31 percent have an ideal score, and the remaining five risk factors are all greater than 40 percent with ideal control. The magnitude of the gap that needs closure is greatest with healthy dietary behaviors, yet it frequently receives the least amount of intervention, and the gap has worsened over the past quarter century. Fewer patients with hypertension today are adhering to healthy nutritional habits than patients a quarter century ago. These suboptimal dietary habits are the leading cause of mortality and disability-adjusted life-years lost, greater than smoking, obesity, physical inactivity, high cholesterol, hypertension, or diabetes.
Lifestyle modification is the cornerstone of cardiovascular disease prevention, and healthy nutritional habits are essential to reducing cardiovascular risk. Changes in diet alone are as effective as blood pressure medications, without side effects associated with pharmacologic intervention. Increase nut consumption lowers cholesterol, and reducing sugar-sweetened beverages reduces risk of weight gain.
More recently, greater attention has been brought to the Mediterranean diet. The Mediterranean diet lowers blood pressure, increases HDL cholesterol, and decreases glucose levels. The term "Mediterranean diet" was first coined by Ancel Keys, best known for the Seven Countries Study, which found lower cardiovascular mortality in Mediterranean vs. non-Mediterranean countries. Since Keys' seminal work, multiple observational studies and randomized controlled trials have demonstrated a diet characterized by abundant olive oil and nut consumption and enriched for fruits, vegetables and fatty fish to be the most likely to reduce risk of cardiovascular events, including myocardial infarction, stroke and death. The Mediterranean diet was speculated to have cardiovascular benefit after observational studies suggested benefit, and the evidence solidified after randomized controlled studies showed superiority of the Mediterranean diet in both high-risk primary prevention populations and secondary prevention populations. The PREDIMED study showed a 30 percent reduction in major adverse cardiovascular events, largely through a reduction in stroke, for those patients at high risk for the development of atherosclerotic disease on a Mediterranean diet enriched for olive oil and nut consumption. The Lyon Diet Heart Study enrolled patients after a first myocardial infarction, and those randomized to receiving a Mediterranean diet enriched with more bread, fish, root vegetables and fish had improved survival and fewer myocardial infarctions than those on a usual prudent diet. Neither study demonstrated any adverse effects of the diet. These studies, however, were conducted in Mediterranean countries, and whether this diet can be successfully implemented in a non-Mediterranean population (and whether the benefits would similarly translate) remains to be tested. Observational studies suggest its possibility in a non-Mediterranean population but this finding remains to be confirmed by randomized controlled trial.
- Conditions
- Cardiovascular Diseases
- Being tested
- Mediterranean Diet - Remote Coaching using a Mobile App
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet - Remote Coaching using a Mobile AppBehavioural
Patients randomized to the intervention arm will be then given an instruction booklet on using Mobile App, directed to a website for additional instruction on its use, and have the app set up to establish connectivity to the RD.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care arm | No intervention | Patients randomized to the Standard-of-care-arm were provided 60 minutes of RD time for consultation through in person visits. |
| Intervention arm | Experimental | Mediterranean Diet - Remote Coaching using a Mobile App.
Patients randomized to the intervention arm were allotted 60 minutes of RD time through a Mobile App (for remote consultation), given an instruction booklet on using Mobile App, directed to a website for additional instruction on its use, and have the app set up to establish connectivity to the RD. Remote coaching by RD was the intervention. Receives: Behavioral: Mediterranean Diet - Remote Coaching using a Mobile App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the Mediterranean Diet Compliance Score at 3 months between the intervention and standard of care groups
The primary endpoint is to compare the Mediterranean Diet Compliance Score, on a scale of 0 to 14, at 3 months between the intervention and standard of care groups. Basic comparisons will be made using Wilcoxon tests to compare medians between the two groups with repeated measures analysis of variance used to compare differences across groups and over time. The higher value represents a better outcome. Subscales will not be combined.
Measured: 3 months
Compare the Mediterranean Diet Compliance Score at 6 months between the intervention and standard of care groups
The primary endpoint is to compare the Mediterranean Diet Compliance Score, on a scale of 0 to 14, at 6 months between the intervention and standard of care groups. Basic comparisons will be made using Wilcoxon tests to compare medians between the two groups with repeated measures analysis of variance used to compare differences across groups and over time. The higher value represents a better outcome. Subscales will not be combined.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start4 Mar 2016
- Primary completion2 Jun 2017
- Study completion31 Aug 2017
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 Cardiovascular DiseasesStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibrent Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- George Washington University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897426
- Sponsor's protocol ID
- HHSN261201400053C_SBIR 308
- Status last verified
- Mar 2019
- First submitted
- 31 Dec 2017
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi BG, Dhawan T, Metzger K, Marshall L, Akbar A, Jain T, Young HA, Katz RJ. Image-Based Mobile System for Dietary Management in an American Cardiology Population: Pilot Randomized Controlled Trial to Assess the Efficacy of Dietary Coaching Delivered via a Smartphone App Versus Traditional Counseling. JMIR Mhealth Uhealth. 2019 Apr 23;7(4):e10755. doi: 10.2196/10755.
PubMed 31012860
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Based Mobile System for Dietary Assessment and Coaching
- ClinicalTrials.gov ID
- NCT03897426
- Acronym / sponsor ID
- HHSN261201400053C_SBIR 308
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vibrent HealthIndustry (pharma, biotech, devices)
- Collaborators
- George Washington University
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 2 Jun 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 1 Apr 2019 (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.
Vignet partnered with The George Washington University Hospital to conduct a randomized control trial (RCT) with to evaluate the system's potential to improve health outcomes for patients with CVD. Results from the RCT have the potential to be applied to patients in other chronic disease contexts.
Detailed description
84 million American adults (>1 in 3) have cardiovascular disease, and cardiovascular disease accounts for 1 of every 3 deaths in the United States and has been the number one cause of deaths in every year since 1918. In addition, strokes, heart attacks, and uncontrolled hypertension are sources of significant disability. However, with control of known cardiovascular risk factors (i.e., smoking, body mass index, physical activity, healthy diet, total cholesterol, blood pressure, fasting plasma glucose), the risk of developing cardiovascular disease is markedly reduced. The most uncontrolled risk factor of these seven metrics for cardiovascular health amongst US adults is healthy dietary behaviors. 73 percent of Americans have a poor diet, and <1 percent have an ideal diet. No other metric of cardiovascular risk comes close - by comparison, the second worst metric is body mass index for which 31 percent have an ideal score, and the remaining five risk factors are all greater than 40 percent with ideal control. The magnitude of the gap that needs closure is greatest with healthy dietary behaviors, yet it frequently receives the least amount of intervention, and the gap has worsened over the past quarter century. Fewer patients with hypertension today are adhering to healthy nutritional habits than patients a quarter century ago. These suboptimal dietary habits are the leading cause of mortality and disability-adjusted life-years lost, greater than smoking, obesity, physical inactivity, high cholesterol, hypertension, or diabetes.
Lifestyle modification is the cornerstone of cardiovascular disease prevention, and healthy nutritional habits are essential to reducing cardiovascular risk. Changes in diet alone are as effective as blood pressure medications, without side effects associated with pharmacologic intervention. Increase nut consumption lowers cholesterol, and reducing sugar-sweetened beverages reduces risk of weight gain.
More recently, greater attention has been brought to the Mediterranean diet. The Mediterranean diet lowers blood pressure, increases HDL cholesterol, and decreases glucose levels. The term "Mediterranean diet" was first coined by Ancel Keys, best known for the Seven Countries Study, which found lower cardiovascular mortality in Mediterranean vs. non-Mediterranean countries. Since Keys' seminal work, multiple observational studies and randomized controlled trials have demonstrated a diet characterized by abundant olive oil and nut consumption and enriched for fruits, vegetables and fatty fish to be the most likely to reduce risk of cardiovascular events, including myocardial infarction, stroke and death. The Mediterranean diet was speculated to have cardiovascular benefit after observational studies suggested benefit, and the evidence solidified after randomized controlled studies showed superiority of the Mediterranean diet in both high-risk primary prevention populations and secondary prevention populations. The PREDIMED study showed a 30 percent reduction in major adverse cardiovascular events, largely through a reduction in stroke, for those patients at high risk for the development of atherosclerotic disease on a Mediterranean diet enriched for olive oil and nut consumption. The Lyon Diet Heart Study enrolled patients after a first myocardial infarction, and those randomized to receiving a Mediterranean diet enriched with more bread, fish, root vegetables and fish had improved survival and fewer myocardial infarctions than those on a usual prudent diet. Neither study demonstrated any adverse effects of the diet. These studies, however, were conducted in Mediterranean countries, and whether this diet can be successfully implemented in a non-Mediterranean population (and whether the benefits would similarly translate) remains to be tested. Observational studies suggest its possibility in a non-Mediterranean population but this finding remains to be confirmed by randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care arm | No intervention | –Patients randomized to the Standard-of-care-arm were provided 60 minutes of RD time for consultation through in person visits. |
| Intervention arm | Experimental | Behavioral: Mediterranean Diet - Remote Coaching using a Mobile AppMediterranean Diet - Remote Coaching using a Mobile App. Patients randomized to the intervention arm were allotted 60 minutes of RD time through a Mobile App (for remote consultation), given an instruction booklet on using Mobile App, directed to a website for additional instruction on its use, and have the app set up to establish connectivity to the RD. Remote coaching by RD was the intervention. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Consecutive patients with ongoing cardiology care with a cardiologist based at the GWU MFA and are expected to remain in the care of that cardiologist for at least 6 months.
- Patients must own their own Android- or Apple iOS-based smartphone with a data plan.
- Patients must give informed consent.
- English language requirement.
- At least 5th grade literacy level as assessed with Rapid Estimate of Adult Literacy in Medicine (REALM).[ ]
Key exclusion criteria (12 listed)
- Clinical instability at time of enrollment.
- Co-morbid medical disease that would preclude ability to participate in a nutrition intervention study (e.g., digestive disease with fat intolerance, life expectancy less than 5 years, severe neurologic, psychiatric or endocrine abnormalities).
- Immunodeficiency or HIV-positive status.
- Illegal drug use, alcoholism or daily alcohol intake >80 g/d.
- BMI>40 kg/m2.
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 |
|---|---|---|
| Mediterranean Diet - Remote Coaching using a Mobile AppPatients randomized to the intervention arm will be then given an instruction booklet on using Mobile App, directed to a website for additional instruction on its use, and have the app set up to establish connectivity to the RD. | Behavioural | Intervention arm |
Primary outcome
Compare the Mediterranean Diet Compliance Score at 3 months between the intervention and standard of care groups
Time frame: 3 months
The primary endpoint is to compare the Mediterranean Diet Compliance Score, on a scale of 0 to 14, at 3 months between the intervention and standard of care groups. Basic comparisons will be made using Wilcoxon tests to compare medians between the two groups with repeated measures analysis of variance used to compare differences across groups and over time. The higher value represents a better outcome. Subscales will not be combined.
Compare the Mediterranean Diet Compliance Score at 6 months between the intervention and standard of care groups
Time frame: 6 months
The primary endpoint is to compare the Mediterranean Diet Compliance Score, on a scale of 0 to 14, at 6 months between the intervention and standard of care groups. Basic comparisons will be made using Wilcoxon tests to compare medians between the two groups with repeated measures analysis of variance used to compare differences across groups and over time. The higher value represents a better outcome. Subscales will not be combined.
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 2 Apr 2019.
- Derived from this study: PubMed 31012860Choi BG, Dhawan T, Metzger K, Marshall L, Akbar A, Jain T, Young HA, Katz RJ. Image-Based Mobile System for Dietary Management in an American Cardiology Population: Pilot Randomized Controlled Trial to Assess the Efficacy of Dietary Coaching Delivered via a Smartphone App Versus Traditional Counseling. JMIR Mhealth Uhealth. 2019 Apr 23;7(4):e10755. doi: 10.2196/10755.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet - Remote Coaching using a Mobile App in people with Cardiovascular Diseases, run by Vibrent Health.
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 9 inclusion and 12 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Compare the Mediterranean Diet Compliance Score at 3 months between the intervention and standard of care groups (time frame: 3 months). The study lists 2 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 NCT03897426, 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 2 Apr 2019; AzTrials last refreshed its copy on 31 Oct 2026.