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
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|Condition or disease||Intervention/treatment||Phase|
|Overweight Obese||Behavioral: fitbit Ultra Behavioral: Pedometer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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.|
|Official Title:||Phase 1 Study of Fitbit and Apps on Healthy Weight Management in Obese Teens in Primary Care Clinics|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||June 1, 2016|
|Actual Study Completion Date :||December 1, 2016|
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.
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
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.
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
- 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%.
- 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.
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|Ages Eligible for Study:||13 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- have acute or life-threatening disease
- not be able to engage in activities of daily living
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693250
|United States, California|
|UCSF School of Nursing|
|San Francisco, California, United States, 94143-0606|
|Principal Investigator:||Jyu-Lin Chen||University of California, San Francisco|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University of California, San Francisco|
|Other Study ID Numbers:||
|First Posted:||September 26, 2012 Key Record Dates|
|Results First Posted:||August 2, 2019|
|Last Update Posted:||August 20, 2019|
|Last Verified:||August 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
healthy weight management
primary care setting