iStart Smart for Teens for Healthy Weight Management
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the
      increased prevalence of childhood obesity in the last two decades. Obesity during the
      adolescent years is associated with many adverse health consequences, including T2DM,
      hyperlipidemia, and psychosocial problems. The first step toward effective obesity management
      and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the
      rapid expansion of cellular networks, and advancements in smartphone technologies, it is now
      possible to monitor PA and dietary intake and at the same time to transmit data digitally to
      their primary care providers (PCP). The proposed pilot study will include the collaboration
      among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese
      adolescents. The study will adapt and implement smartphone-based technologies and integrate
      these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake.
      Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the
      smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the
      effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid
      profile), at 3 months post intervention between the intervention and control groups. The
      smartphone app for the intervention group will allow the teens to graphically compare daily
      PA and dietary intake with the goal, participate in a reward program where they can collect
      virtual points for achieving the goal, and play interactive games related to PA and diet. A
      total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to
      the feasibility study (Aim 2).
    

Detailed description: 
      Using evidence to inform the design of clinical practice is a foundational principle of
      modern health care practice. In the present pilot study, using evidence from research on
      technology in clinical practice facilitated development of a hybrid intervention that
      combined lifestyle modification with routine clinical care. Chief among the benefits of this
      hybrid smartphone technology-based intervention (STB) was the potential to improve health
      outcomes and reduce obesity in overweight and obese adolescents. The purposes of this study
      were to (1) measure effects of an innovative smartphone-technology-based (STB) intervention
      for overweight and obese adolescents and to (2) examine the intervention's feasibility for
      use in primary care clinics.The STB intervention had 3 components: use of Fitbit Flex,
      participation in the online educational program, and receipt of bi-weekly text message during
      the maintenance phase. A randomized control study design was utilized. Data regard to
      anthropometrics (BMI and waist-hip ratio), blood pressure, levels of physical and sedentary
      activity, diet, and self-efficacy regarding physical activity and diet were collected at
      baseline, 3 month and 6 months after the baseline assessment.
    

Intervention name(s): fitbit Ultra; Pedometer
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.; adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.
Other intervention name(s): Fitbit Ultra and associated apps; Omron HJ-105 pedometer
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized control study design with an active control group was used.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: technology; healthy weight management; primary care setting