Collaborative and Adaptive Recommender for Personalized DIEt Management
Condition: Diet Habit; Sleep; Life Style, Healthy; Physical Activity
Study type: Interventional

Summary: 
      CarpeDiem is a mobile application which provides personalized and holistic recommendations in
      the area of diet, physical activity and sleep to help their users adopt a healthier
      lifestyle. In this study it is hypothesized that the usage of this application can achieve a
      more effective lifestyle improvement than an intervention with the use of wearables, their
      respective generic applications and general healthy lifestyle recommendations. Therefore,
      this study aims to assess whether the incorporation of a mobile application such as
      CarpeDiem, which includes smart, personalized and holistic recommendations related to a
      healthy lifestyle (diet, physical activity and sleep) is associated with a more pronounced
      change in healthy lifestyle habits than a passive monitoring approach using wearables and the
      administration of general recommendations.

      This clinical trial consists of a multicenter pilot study performed at the headquarters of
      the Technology Center of Catalonia (Eurecat), randomized, parallel and controlled, performed
      with healthy adults (18 to 65 years old). 100 subjects will be recruited, 50 as an
      intervention group and 50 as a control group. The study is scheduled to begin in June 2021.

      Both groups will receive an activity tracker (Fitbit Inspire HR 2). The intervention group
      will also receive instructions to download and use the CarpeDiem application. Through the
      CarpeDiem application, participants will be able to answer follow-up questionnaires, perform
      missions related to the healthy consumption of various food groups, monitor their physical
      activity and sleep, and receive periodic, personalized and holistic recommendations based on
      the three pillars of health. The control group will receive instructions to download the
      Fitbit application and will additionally receive general recommendations for healthy
      lifestyle habits through standardized documents. Both groups will be provided access to the
      initial and final questionnaires that will be done online. All participants must return the
      signed informed consent either with a digital signature or by mail to the Eurecat-Barcelona
      headquarters.

      The main variable of the study is: the Mediterranean lifestyle index, calculated from the
      short MEDLIFE questionnaire with 28 items, validated for the Spanish adult population.

      The secondary variables are:

      Diet related: Food intake and food groups taken from the Food Frequency Questionnaire (CFCA).
      Diet diversity index calculated from the CFCA.

      Related to physical activity: Total physical activity in MET-minutes / week, extracted from
      the IPAQ questionnaire. Data referring to daily activity (minutes sitting and moderate and
      intense physical activity and number of steps taken) measured with the activity bracelet.

      Sleep-related: Sleep quality index, derived from the Pittsburg Sleep Quality Questionnaire
      (PSQI). Data referring to users' daily sleep (sleep duration, efficiency, start and end)
      measured with the activity bracelet.

      Related to the user's experience in using the application, evaluated through the UEQ
      questionnaire. Only at the end of the intervention.

      In total, subjects will receive 3 visits:

      Visit 0, pre-screening visit before randomization to check inclusion / exclusion criteria,
      using an online form.

      Visit 1, after randomization, inclusion visit. Participants will receive the activity
      bracelet and informed consent at their homes. During this visit, participants will answer the
      questionnaires using online forms.

      Visit 2, after three months, final visit of the study intervention. Participants will answer
      the questionnaires using online forms.
    


Intervention name(s): Mobile app
Intervention type(s): Device
Intervention description(s): The CarpeDiem application is a mobile application, designed in collaboration with the Health and Nutrition Technology Unit (UTNS, Eurecat) and the translational research group on respiratory medicine of the Institut de Recerca Biomèdica de Lleida. The application is available for devices with Android as the operative system and its advanced interface allows the user to monitor their physical activity, sleep and diet and motivate them to meet personalized goals through gamification. To do this, the user must answer the questionnaires that they will find on the main page of the application with a predetermined frequency, as well as perform missions that will help them acquire healthier habits. In addition, the user will receive motivational messages and recommendations through notifications that will help and guide them to achieve their missions and achieve their goals, and as a result of changing habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention