Image Based Mobile System for Dietary Assessment and Coaching
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mediterranean Diet - Remote Coaching using a Mobile App
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention