Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

iStart Smart for Teens for Healthy Weight Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Overweight
Obese
Interventions Behavioral: fitbit Ultra
Behavioral: Pedometer
Enrollment 40
Recruitment Details The trained research assistant worked with primary care providers at two large community clinics whose patient populations were predominantly Chinese American in northern California. A study invitation letter was posted in the clinics. Pediatricians at the clinics were also given a study invitation letter to give to potential participants.
Pre-assignment Details An explanation of why potential participants were excluded from the study before assignment to groups was given them.
Arm/Group Title Fitbit Ultra Pedometer
Hide Arm/Group Description

A total of 23 adolescents in the intervention group received 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.

fitbit Ultra: Participants were 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.

A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

Period Title: Overall Study
Started 23 [1] 17 [2]
Completed 21 [3] 15 [4]
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
[1]
3 months post baseline assessment
[2]
three month post baseline assessment
[3]
21 teens completed 6 months post baseline assessment
[4]
15 teens completed 6 months post baseline assessment
Arm/Group Title Fitbit Ultra Pedometer Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 23 17 40
Hide Baseline Analysis Population Description
23 participants were assigned to the fitbit ultra group and 17 were assigned to Pedometer group
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 17 participants 40 participants
<=18 years
23
 100.0%
17
 100.0%
40
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 17 participants 40 participants
15.0  (1.66) 14.8  (1.69) 14.9  (1.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 17 participants 40 participants
Female
8
  34.8%
9
  52.9%
17
  42.5%
Male
15
  65.2%
8
  47.1%
23
  57.5%
1.Primary Outcome
Title Body Mass Index (BMI)
Hide Description 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%.
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fitbit Ultra Pedometer
Hide Arm/Group Description:

Participants in the intervention group received 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.

fitbit Ultra: Participants were 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.

After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

Overall Number of Participants Analyzed 23 17
Mean (Standard Deviation)
Unit of Measure: kg/m^2
baseline data 27.37  (3.26) 28.35  (4.36)
6 months data 26.93  (3.42) 29.18  (3.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fitbit Ultra, Pedometer
Comments This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.68
Parameter Dispersion
Type: Standard Deviation
Value: .5
Estimation Comments [Not Specified]
2.Other Pre-specified Outcome
Title Diastolic Blood Pressure
Hide Description 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.
Time Frame baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Adolescents who are overweight or obese were invited to participate in this study,
Arm/Group Title Fitbit Ultra Pedometer
Hide Arm/Group Description:

A total of 23 adolescents in the intervention group received 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.

fitbit Ultra: Participants were 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.

A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

Overall Number of Participants Analyzed 23 17
Mean (Standard Deviation)
Unit of Measure: mmhg
baseline 72.74  (8.07) 69.94  (11.25)
6 month 70.15  (7.53) 72.14  (8.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fitbit Ultra, Pedometer
Comments We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.66
Estimation Comments [Not Specified]
Time Frame The study period is 6 months, therefore, adverse event data were collected over 6 months.
Adverse Event Reporting Description Any adverse event happened during the study period will be reported to UCSF Institutional Review Board. The IRB will review the adverse event report and determine if a) the risk-benefit ratio continues to be acceptable, b) the research protocol and informed consent document accurately and completely present risk information, c) current subjects should be advised of newly identified risks and d) the event meets the definition of an Unanticipated Problem involving risk to participants or others.
 
Arm/Group Title Fitbit Ultra Pedometer
Hide Arm/Group Description

A total of 23 adolescents in the intervention group received 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.

fitbit Ultra: Participants were 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.

A total of 17 adolescent included in the control group. After completion of the baseline assessments, adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

Pedometer: adolescents in the control group were given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

All-Cause Mortality
Fitbit Ultra Pedometer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/17 (0.00%) 
Hide Serious Adverse Events
Fitbit Ultra Pedometer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fitbit Ultra Pedometer
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/17 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jyu-Lin Chen
Organization: University of California San Francisco
Phone: 415-502-6015
EMail: jyu-lin.chen@ucsf.edu
Other Publications:
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01693250    
Other Study ID Numbers: TEENS-2012
First Submitted: September 19, 2012
First Posted: September 26, 2012
Results First Submitted: October 24, 2017
Results First Posted: August 2, 2019
Last Update Posted: August 20, 2019