Trial Outcomes & Findings for iStart Smart for Teens for Healthy Weight Management (NCT NCT01693250)

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2019-08-20

Participant Flow

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.

An explanation of why potential participants were excluded from the study before assignment to groups was given them.

Participant milestones

Participant milestones
Measure	Fitbit Ultra 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.	Pedometer 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 Study STARTED	23	17
Overall Study COMPLETED	21	15
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Fitbit Ultra 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.	Pedometer 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 Study Lost to Follow-up	2	2

Baseline Characteristics

iStart Smart for Teens for Healthy Weight Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fitbit Ultra n=23 Participants 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.	Pedometer n=17 Participants 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 n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	15.0 years STANDARD_DEVIATION 1.66 • n=5 Participants	14.8 years STANDARD_DEVIATION 1.69 • n=7 Participants	14.9 years STANDARD_DEVIATION 1.67 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	8 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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%.

Outcome measures

Outcome measures
Measure	Fitbit Ultra n=23 Participants 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.	Pedometer n=17 Participants 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.
Body Mass Index (BMI) baseline data	27.37 kg/m^2 Standard Deviation 3.26	28.35 kg/m^2 Standard Deviation 4.36
Body Mass Index (BMI) 6 months data	26.93 kg/m^2 Standard Deviation 3.42	29.18 kg/m^2 Standard Deviation 3.88

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline and 6 months

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

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.

Outcome measures

Outcome measures
Measure	Fitbit Ultra n=23 Participants 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.	Pedometer n=17 Participants 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.
Diastolic Blood Pressure baseline	72.74 mmhg Standard Deviation 8.07	69.94 mmhg Standard Deviation 11.25
Diastolic Blood Pressure 6 month	70.15 mmhg Standard Deviation 7.53	72.14 mmhg Standard Deviation 8.71

Adverse Events

Fitbit Ultra

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pedometer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jyu-Lin Chen

University of California San Francisco

Phone: 415-502-6015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place