iStart Smart for Teens for Healthy Weight Management
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). Findings from this study will be used to plan for a NIH R01.
Device: fitbit Ultra
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase 1 Study of Fitbit and Apps on Healthy Weight Management in Obese Teens in Primary Care Clinics|
- Body mass index (BMI) [ Time Frame: three month post intervention ] [ Designated as safety issue: No ]change of BMI at 3 month post intervention will be computed
- Physical activity [ Time Frame: three month post intervention ] [ Designated as safety issue: No ]Accelerometer (Actigraph) will provide physical activity data
- Blood pressure [ Time Frame: three month post intervention ] [ Designated as safety issue: No ]change of blood pressure while seating at 3 month post intervention will be computed
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: fitbit ultra
Adolescents in the intervention group will receive a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.
Device: fitbit Ultra
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.
Other Name: Fitbit Ultra and associated apps
Active Comparator: Pedometer
After completion of the baseline assessments, 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.
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 Name: Omron HJ-105 pedometer
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693250
|Contact: Jyu-Lin Chen, PhDfirstname.lastname@example.org|
|United States, California|
|UCSF School of Nursing||Not yet recruiting|
|San Francisco, California, United States, 94143-0606|
|Contact: Jyu-Lin Chen, PhD 415-502-6015 email@example.com|
|Principal Investigator: Jyu-Lin Chen, PhD|