Personal Lifestyle Engine (PLX) - Personal Lifestyle Medicine Center (PLMC)
Condition: Health, Subjective; Gastrointestinal Dysfunction; Cardiovascular Risk Factor; Autoimmune Diseases; Dental Diseases; Hormone Disturbance; Neurocognitive Dysfunction
MeSH terms: Stomatognathic Diseases; Endocrine System Diseases; Autoimmune Diseases; Cognitive Dysfunction
Study type: Observational

Summary: 
      It has been suggested that the best medicine should include four principles (4P) - Medicine
      should be personalized, predictive, preventative and participatory. Technology has provided
      the tools to collect data in ways not previously possible. Individuals can now collect
      information on their genome (including their genetic predisposition to tolerate medications
      and to respond to healthy lifestyle programs) that will modify their lifestyle and
      therapeutic choices. Beyond spot checks of vital signs and weight, individuals can now
      collect information on body composition, continuous monitoring of heart rate, blood pressure,
      and even blood sugar. Data on food consumption at a caloric, macronutrient and even
      micronutrient level can be collected. Standard medical histories and detailed physical
      examination findings and laboratory biomarkers can be correlated with this data.

      Collections of individual patient data will need to be managed through computer programs and
      smart phone applications that provide direct feedback about the influence of lifestyle on
      health, wellness and biomarkers. To this end, Metagenics is designing and is launching a
      smart phone application, Personal Lifestyle Engine (PLX), for individual use by patients and
      their healthcare providers. The statistical analysis of these data is the primary objective
      of this study.
    

Detailed description: 
      Technology has led to a significant revisioning and modification of the models of medicine in
      practice today. It has been suggested that the best medicine should include four principles -
      Medicine should be personalized, predictive, preventative and participatory. This 4P medicine
      will thus be patient centered with a focus on the person who has the disease and not the
      disease the person has. It will be predictive as it identifies the preclinical trend/decline
      towards illness sooner than onset of symptoms that herald the loss of function and health. It
      will be preventative as the information gathered should offer opportunities to modify these
      trajectories towards illness and finally it will be participatory as individuals will be
      intimately involved in the gathering of data to identify trends and in the application of
      lifestyle measures to improve the quality of their life.

      Technology has provided the tools to collect data in ways not previously possible.
      Individuals can now collect information on their genome (including their genetic
      predisposition to tolerate medications and to respond to healthy lifestyle programs) that
      will modify their lifestyle and therapeutic choices. Beyond spot checks of vital signs and
      weight, individuals can now collect information on body composition, continuous monitoring of
      heart rate, blood pressure, and even blood sugar. Data on food consumption at a caloric,
      macronutrient and even micronutrient level can be collected. Standard medical histories and
      detailed physical examination findings and laboratory biomarkers can be correlated with this
      data.

      As has been noted in the Nathan Price et al. article, "A wellness study of 108 individuals
      using personal, dense, dynamic data clouds" (PMID: 28714965), a significant challenge to the
      effective use of these complex sets of individual patient data is how to define the
      boundaries between disease, average health and optimal wellbeing. To meet this challenge,
      compiling and analyzing collections of de-identified, detailed patient histories,
      questionnaires regarding symptoms and general condition, and associated objective findings
      (genomic data, vital signs, and physical exam and laboratory biomarkers) will theoretically
      identify these boundaries and will facilitate the deliverance of 4P Medicine. Comprehensive
      data collections on each subject evaluated in aggregate provides a diversity of uniqueness
      markers that can be statistically probed to identify patterns that predict wellbeing and
      perhaps individual response to lifestyle interventions.

      An additional challenge for both the patient and their health care provider in 2018 and
      beyond is how to manage this data in an effective manner. Collections of individual patient
      data will need to be managed through computer programs and smart phone applications that
      provide direct feedback about the influence of lifestyle on health, wellness and biomarkers.
      To this end, Metagenics is designing and is launching a smart phone application, PLX, for
      individual use by patients and their healthcare providers. After and while a statistical
      analysis of this data set has been/is being completed, the data set will also be used in an
      initial beta test of the PLX operating system. The PLX application will not be used to
      conduct the statistical analysis which is the primary objective of this study."
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited first from Metagenics employees but expand to family members of
        employees and from the general population. It is expected that subjects will be recruited
        from the private practices of both Study Investigators and associated clinical staff.
      
Keywords: wellness; personalized medicine; functional medicine; 4P medicine; employee wellness program; functional capacity; smart phone application