iStart Smart for Teens for Healthy Weight Management

• 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: University of California, San Francisco
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Fitbit Ultra	Pedometer	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Body Mass Index (BMI)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fitbit Ultra	Pedometer
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)

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
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

Outcome Measure Data

Analysis Population Description

Adolescents who are overweight or obese were invited to participate in this study,

Arm/Group Title	Fitbit Ultra	Pedometer
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)

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]

Adverse Events

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
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%)
Serious Adverse Events
	Fitbit Ultra	Pedometer
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/23 (0.00%)	0/17 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Dr. Jyu-Lin Chen
• Organization: University of California San Francisco
• Phone: 415-502-6015
• EMail: jyu-lin.chen@ucsf.edu

Publications of Results:

Chen JL, Guedes CM, Lung AE. Smartphone-based Healthy Weight Management Intervention for Chinese American Adolescents: Short-term Efficacy and Factors Associated With Decreased Weight. J Adolesc Health. 2019 Apr;64(4):443-449. doi: 10.1016/j.jadohealth.2018.08.022. Epub 2018 Nov 6.

Other Publications:

Karnik S, Kanekar A. Childhood obesity: a global public health crisis. Int J Prev Med. 2012 Jan;3(1):1-7.

Wang LY, Chyen D, Lee S, Lowry R. The association between body mass index in adolescence and obesity in adulthood. J Adolesc Health. 2008 May;42(5):512-8. doi: 10.1016/j.jadohealth.2007.10.010. Epub 2008 Jan 31.

Chen JL, Wilkosz ME. Efficacy of technology-based interventions for obesity prevention in adolescents: a systematic review. Adolesc Health Med Ther. 2014 Aug 7;5:159-70. doi: 10.2147/AHMT.S39969. eCollection 2014. Review.

Chen JL, Weiss S, Heyman MB, Cooper B, Lustig RH. The efficacy of the web-based childhood obesity prevention program in Chinese American adolescents (Web ABC study). J Adolesc Health. 2011 Aug;49(2):148-54. doi: 10.1016/j.jadohealth.2010.11.243. Epub 2011 Mar 12.

Delamater AM, Pulgaron ER, Rarback S, Hernandez J, Carrillo A, Christiansen S, Severson HH. Web-based family intervention for overweight children: a pilot study. Child Obes. 2013 Feb;9(1):57-63. doi: 10.1089/chi.2011.0126. Epub 2013 Jan 11.

Sim LA, Lebow J, Wang Z, Koball A, Murad MH. Brief Primary Care Obesity Interventions: A Meta-analysis. Pediatrics. 2016 Oct;138(4). pii: e20160149. Epub 2016 Sep 12. Review.

Al-Khudairy L, Loveman E, Colquitt JL, Mead E, Johnson RE, Fraser H, Olajide J, Murphy M, Velho RM, O'Malley C, Azevedo LB, Ells LJ, Metzendorf MI, Rees K. Diet, physical activity and behavioural interventions for the treatment of overweight or obese adolescents aged 12 to 17 years. Cochrane Database Syst Rev. 2017 Jun 22;6:CD012691. doi: 10.1002/14651858.CD012691. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen JL, Guedes CM, Cooper BA, Lung AE. Short-Term Efficacy of an Innovative Mobile Phone Technology-Based Intervention for Weight Management for Overweight and Obese Adolescents: Pilot Study. Interact J Med Res. 2017 Aug 2;6(2):e12. doi: 10.2196/ijmr.7860.

• 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