Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 1 Study of Fitbit and Apps on Healthy Weight Management in Obese Teens in Primary Care Clinics
Brief 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).


Options:
A: Changes from baseline BMI (At baseline (0 years) and followed for 2 years); Changes from baseline Fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Free-fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Muscular Mass (At baseline (0 years) and followed for 2 years); Changes from baseline Corporal Water (At baseline (0 years) and followed for 2 years); Adherence to dietary pattern will be also measured through personal interview (At baseline (0 years) and followed for 2 years); Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire) (At baseline (0 years) and followed for 2 years); Changes from baseline in the number of steps per day (At baseline (0 years) and followed for 2 years)
B: Body Mass Index (BMI) (baseline and 6 months)
C: Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Adjusting Amount Task) (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Monetary Choice Questionnaire) (Phase II baseline to 2 months and 4 months (end of treatment))
D: Percent weight loss: objective (Baseline, 6 Months); Weight (Baseline, 6 Months)

Answer: B