iStart Smart for Teens for Healthy Weight Management
|ClinicalTrials.gov Identifier: NCT01693250|
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obese||Device: fitbit Ultra Device: Pedometer||Phase 1 Phase 2|
|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|
|Primary Completion Date :||June 1, 2016|
|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.
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.
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: three month post intervention ]change of BMI at 3 month post intervention will be computed
- Physical activity [ Time Frame: three month post intervention ]Accelerometer (Actigraph) will provide physical activity data
- Blood pressure [ Time Frame: three month post intervention ]change of blood pressure while seating at 3 month post intervention will be computed
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|