Mode
Text Size
Log in / Sign up
N/A N=40 Randomized Double-blind Prevention

iStart Smart for Teens for Healthy Weight Management

Overweight · Obese

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Body Mass Index (BMI) — 27.37; 28.35; 26.93; 29.18 kg/m^2 — p=<.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
fitbit Ultra (Behavioral); Pedometer (Behavioral)
Age
Pediatric, Adult · 13+ yrs
Sex
All
Sponsor
University of California, San Francisco
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Body Mass Index (BMI)
27.37; 28.35; 26.93; 29.18 <.001 sig

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).

Eligibility Criteria

Inclusion Criteria

  • between 13-18 years old
  • have a BMI at ≥ 85th percentile, based on CDC growth chart
  • own a smartphone;
  • have access to a computer with internet access
  • be able to read and speak English.

Exclusion Criteria

  • have acute or life-threatening disease
  • not be able to engage in activities of daily living
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01693250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search