Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents
Condition: Adolescent Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      The prevention of overweight and obesity in adolescents is a public health priority given the
      impact of obesity on both short- and long-term health. Scientific evidence has shown that
      interventions in diet and physical exercise can reduce the risk of obesity in children and
      young people since adolescence is an ideal stage for educating on a healthy lifestyle and
      correcting the habits that may have been acquired in childhood. Smartphone applications
      (apps) can provide a useful alternative to overweight and obesity prevention measures.

      The objective of this study was to evaluate, through a randomized controlled clinical trial,
      the effect of an intervention based on a mobile health application (m-Health) on improving
      the degree of sport and nutrition knowledge, eating habits, and level of physical activity of
      adolescents.

      The sample consists of 305 adolescents, 154 in the intervention group and 151 in the control
      group that are evaluated at the beginning and 6 months later regarding sociodemographic,
      eating habits, food knowledge, level of physical activity, body mass index, and waist
      circumference. The educational intervention was carried out using an m-Health tool, a mobile
      phone application. The outcomes were changes in the mentioned variables to a six-month
      follow-up between the two groups.
    

Detailed description: 
      Design: A randomized parallel-group, controlled clinical trial was performed on adolescents
      from public secondary schools in the province of Cadiz, Spain.

      Randomization and Blinding: The randomization and allocation to each group (1:1,
      intervention, and usual care) are based on computer-generated random numbers stratified in
      the three courses of secondary education. The researchers responsible for the study do not
      participate in the allocation of the participants. Due to the kind of intervention, blinding
      is not possible when the participants are allocated to groups. To minimize any bias,
      objective clinical variables are measured during the evaluation visit and the analyses are
      performed by blinded researchers.

      Study Sample: The estimated sample size to detect a mean difference of at least one point in
      the level of healthy eating habits, measured by the KidMed questionnaire, with a standard
      deviation of the values in the questionnaire known from previous studies of 2.5 points, a
      level of confidence of 95% and statistical power of 90%, it was 126 participants in each
      group, intervention, and control. Assuming a 20% loss to follow-up, 305 participants were
      recruited, 154 in the intervention group and 151 in the control group.

      Recruitment: All participants, in the intervention and control groups, received an
      Intervention on healthy habits consisting of four sessions developed by a nurse over two
      months. Adolescents who voluntarily decided to participate in the mobile Health educational
      intervention were recruited by a nurse. Both the adolescents and their parents signed the
      informed consent.

      Intervention: The nurse installs the application on the mobile phone of the participants in
      the intervention group. It is a friendly, easy-to-use application for smartphones and tablets
      that favors the process of learning while playing.

      Application Contents: Through the application, the adolescent participates in five
      activities: food, exercises, tests, learning more, and games that are different from each
      other but interconnected and that allow progress to be seen. The application "Care your
      habits" has educational materials on nutrition and physical activity. The participant records
      the food eaten and the physical activity performed, in addition to answering health
      questionnaires.

      Technical Data of the Application:

      The application has been developed for Android mobiles with versions between API 16 and API
      28, which guarantees user compatibility. This app uses Firebase, a cloud platform that
      enables certain features, such as a secure login for app users. The application uses an
      initial Activity, which is responsible for managing the Login. The application is structured
      in different Fragments. Each of these Fragments is made up of a layout that is the graphical
      interface that the user sees and a class in the Java programming language that is the part in
      charge of processing the user's interaction with the interface and performing the appropriate
      action.

      The app needs a server that manages interactions with the database where the data that users
      provide voluntarily from the app itself is stored. The part of the server that supports and
      complements the Android application is made up of a RESTful API developed in the NodeJS
      programming language. This server communicates with Firebase in order to verify the identity
      of the user who is providing data at all times, so that a user could not falsify another
      user's data.

      All of this information is persistently stored in a NoSQL database, specifically a MongoDB
      database. The information provided by users is encrypted to prevent data theft.

      Ethical Considerations: The study was conducted in agreement with the guidelines and
      protocols established in the Helsinki Declaration as revised in Fortaleza (Brazil) in October
      2013, and complies with Law 14/2007 on Biomedical Research and with European Data Protection
      Regulations. The Biomedical Research Ethics Committee of Cádiz, Andalusian, approved the
      project with the reference: 11_02_2019. The informed written consent of all the participants
      and their parents was requested. The application guarantees security measures regarding the
      current General Data Protection Regulations in Europe. It also includes data encryption
      mechanisms.
    

Intervention name(s): Mobile health application
Intervention type(s): Device
Intervention description(s): Health intervention through a smartphone application that favors the process of learning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: mobile application; eating habits; physical activity; overweight; nutrition knowledge