Promoting Mental and Physical Well-being Through Smart Health
Condition: Health Behavior; Healthy Lifestyle
Study type: Observational [Patient Registry]

Summary: 
      The objective of the study is to develop a smartphone application dedicated to health
      prevention in terms of monitoring physical activity and healthy eating, mediated by the use
      of Mindfulness-ACT exercises to reduce unhealthy lifestyles and monitoring through the use of
      engineered wearable bands.

      This is a nonpharmacological prospective observational study. The procedure includes
      consecutive enrollment in the study of 40 subjects who meet all inclusion criteria. Patients
      will undergo comprehensive cognitive assessment with collection of all medical history data
      and information on current clinical condition, including dietary lifestyle. After that they
      will be invited to register on Brainhearth platform, and then via the app monitoring of
      physical activity and nutrition, mediated by the use of Mindfulness-ACT exercises, will take
      place.
    

Detailed description: 
      The Brainheart study aims to develop a smartphone application connected to a smartwatch
      dedicated to the prevention of cardiovascular disease among the elderly in their activities
      of daily living. In addition, to promote health by monitoring physical activity through
      special engineered bands and healthy eating, mediated by the use of Mindfulness-ACT exercises
      and appropriate dietary regimen, according to the attached scheme (Appendix A);to acquire
      physiological and behavioral correlates through the BRAINHEART platform;to develop physical
      activity, nutrition and interactive exercise programs based on MCBT and ACT; administering
      contextualized MCBT and ACT cognitive behavioral exercises to promote program
      adherence;enhancing meta-cognitive skills through a better understanding of the individual
      with respect to his or her own cognitive processes and their functioning;improving quality of
      life and one's mental and physical well-being;increasing scientific and clinical knowledge
      for mental and physical well-being and strategies to promote it;increasing sense of
      self-efficacy and self-esteem. To achieve these goals, the application developed on a mobile
      platform, will be designed by integrating:

        -  a multi-sensory wearable device capable of acquiring and processing physiological and
           behavioral data to monitor physical and mental health status

        -  advanced artificial intelligence-based decision support models that can recognize
           physical and mental health status and provide personalized physical activity and
           nutrition programs

        -  exercises and interactive games based on the cognitive behavioral technique Mindfulness
           and ACT, contextualized and customized in order to increase awareness of health status
           and motivate the elderly to pursue a healthy lifestyle and best follow the
           cerebrocardiovascular disease prevention program

      STUDY DESIGN.

      This is a nonpharmacological prospective observational study.

      DURATION OF THE STUDY

      Overall, the study will have a duration of 12 months.

      STUDY POPULATION

      A total of 40 subjects will be consecutively enrolled in the study who are afferent to the
      facility's outpatient clinics and meet all inclusion criteria, and who will be evaluated at
      the time of recruitment (T0), and at 6 (T1) and 12 months (T2) intervals. All patients will
      be assessed by the (a) MMSE, (b) batteries provided within the Brief Neuropsychological
      Examination, (c) quality of life assessment questionnaires, and (d) Mini Nutritional
      Assessment (see Annex A to this protocol).

      Inclusion criteria

        -  Age of subjects: 50-85 years.

        -  Subjects with global cognitive functioning at normal limits (MMSE ≥ 20)

        -  Subjects with a diagnosis of mild and/or absent depression

      Exclusion criteria.

        -  Diagnosis of dementia

        -  Diagnosis of moderate/severe depression

        -  Speech disorders;

        -  Psychiatric disorders;

        -  Praxic deficits.

      Materials

      The project involves the use of:

        -  portable devices with adequate computational and memory capabilities;

        -  wireless wearable sensors capable of simultaneously measuring heart rate (HR), and
           physical activity using triaxial accelerometer;

        -  mobile processing units for extraction of biosignal features and automatic
           classification of stress levels.
    

Intervention name(s): ACT MINDFULNESS
Intervention type(s): Behavioral
Intervention description(s): Mindfulness (MCBT) practices were offered to patients with the aim of fostering the elderly's pro-active role in health prevention by making them
aware of the relationship between thoughts, emotions and symptomatology of the disorder. The exercises will also be used as a motivational work tool within a protocol of Acceptance and Commitment Therapy (ACT), a new generation cognitive behavioral approach, in which "commitment" components are added to mindfulness, suitable for lifestyle modification.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Forty subjects (20 adult subjects for the experimental group and 20 adult subjects for the
        control group) were recruited from the Bonino-Pulejo Neurolesi Center in Messina, Italy.