iStart Smart for Teens for Healthy Weight Management

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01693250
First received: September 19, 2012
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Overweight
Obese
Device: fitbit Ultra
Device: Pedometer
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Physical activity [ Time Frame: three month post intervention ] [ Designated as safety issue: No ]
    Accelerometer (Actigraph) will provide physical activity data


Other Outcome Measures:
  • 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


Estimated Enrollment: 60
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: 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.
Other Name: Omron HJ-105 pedometer

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693250

Contacts
Contact: Jyu-Lin Chen, PhD 415-502-6015 jyu-lin.chen@nursing.ucsf.edu

Locations
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    jyu-lin.chen@nursing.ucsf.edu   
Principal Investigator: Jyu-Lin Chen, PhD         
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01693250     History of Changes
Other Study ID Numbers: TEENS-2012
Study First Received: September 19, 2012
Last Updated: March 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
technology
healthy weight management
primary care setting

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014