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iStart Smart for Teens for Healthy Weight Management

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ClinicalTrials.gov Identifier: NCT01693250
Recruitment Status : Completed
First Posted : September 26, 2012
Results First Posted : August 2, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 19, 2012
First Posted Date  ICMJE September 26, 2012
Results First Submitted Date  ICMJE October 24, 2017
Results First Posted Date  ICMJE August 2, 2019
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
Body Mass Index (BMI) [ Time Frame: baseline and 6 months ]
Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%.
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
Body Mass Index (BMI) [ Time Frame: three month post intervention ]
change of BMI at 3 month post intervention will be computed
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2012)
Physical activity [ Time Frame: three month post intervention ]
Accelerometer (Actigraph) will provide physical activity data
Current Other Pre-specified Outcome Measures
 (submitted: June 14, 2019)
Diastolic Blood Pressure [ Time Frame: baseline and 6 months ]
Systolic blood pressure and diastolic blood pressure were measured by using a mercury sphygmomanometer with specific cuff size appropriate for adolescents (Baumanometer, W. A. Baum Co., Copiague, New York). After participants sat for 10 minutes, blood pressure was measured twice in the adolescent's right arm; blood pressures were measured to the nearest 2 mmHg. Average score of two measures was used.
Original Other Pre-specified Outcome Measures
 (submitted: September 21, 2012)
Blood pressure [ Time Frame: three month post intervention ]
change of blood pressure while seating at 3 month post intervention will be computed
 
Descriptive Information
Brief Title  ICMJE iStart Smart for Teens for Healthy Weight Management
Official Title  ICMJE 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).
Detailed Description Using evidence to inform the design of clinical practice is a foundational principle of modern health care practice. In the present pilot study, using evidence from research on technology in clinical practice facilitated development of a hybrid intervention that combined lifestyle modification with routine clinical care. Chief among the benefits of this hybrid smartphone technology-based intervention (STB) was the potential to improve health outcomes and reduce obesity in overweight and obese adolescents. The purposes of this study were to (1) measure effects of an innovative smartphone-technology-based (STB) intervention for overweight and obese adolescents and to (2) examine the intervention's feasibility for use in primary care clinics.The STB intervention had 3 components: use of Fitbit Flex, participation in the online educational program, and receipt of bi-weekly text message during the maintenance phase. A randomized control study design was utilized. Data regard to anthropometrics (BMI and waist-hip ratio), blood pressure, levels of physical and sedentary activity, diet, and self-efficacy regarding physical activity and diet were collected at baseline, 3 month and 6 months after the baseline assessment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A randomized control study design with an active control group was used.
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description:
Primary care providers and outcome assessors were blinded to the group assignment.
Primary Purpose: Prevention
Condition  ICMJE
  • Overweight
  • Obese
Intervention  ICMJE
  • 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.
    Other Name: Fitbit Ultra and associated apps
  • 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.
    Other Name: Omron HJ-105 pedometer
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: fitbit Ultra
  • 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.
    Intervention: Behavioral: Pedometer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2012)
60
Actual Study Completion Date  ICMJE December 1, 2016
Actual Primary Completion Date June 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01693250
Other Study ID Numbers  ICMJE TEENS-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jyu-Lin Chen University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP