iStart Smart for Teens for Healthy Weight Management

NCT01693250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-08-20

Study results available
· View outcomes & findings →

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).

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Pedometer

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.

Sponsors & Collaborators

Principal Investigators

  • Jyu-Lin Chen · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-01
Completion
2016-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01693250 on ClinicalTrials.gov