iStart Smart for Teens for Healthy Weight Management
Primary Purpose
Overweight, Obese
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fitbit Ultra
Pedometer
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring technology, healthy weight management, primary care setting
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- have acute or life-threatening disease
- not be able to engage in activities of daily living
Sites / Locations
- UCSF School of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
fitbit ultra
Pedometer
Arm 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.
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.
Outcomes
Primary Outcome Measures
Body Mass Index (BMI)
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%.
Secondary Outcome Measures
Full Information
NCT ID
NCT01693250
First Posted
September 19, 2012
Last Updated
August 9, 2019
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01693250
Brief Title
iStart Smart for Teens for Healthy Weight Management
Official Title
Phase 1 Study of Fitbit and Apps on Healthy Weight Management in Obese Teens in Primary Care Clinics
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the increased prevalence of childhood obesity in the last two decades. Obesity during the adolescent years is associated with many adverse health consequences, including T2DM, hyperlipidemia, and psychosocial problems. The first step toward effective obesity management and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the rapid expansion of cellular networks, and advancements in smartphone technologies, it is now possible to monitor PA and dietary intake and at the same time to transmit data digitally to their primary care providers (PCP). The proposed pilot study will include the collaboration among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese adolescents. The study will adapt and implement smartphone-based technologies and integrate these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake. Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid profile), at 3 months post intervention between the intervention and control groups. The smartphone app for the intervention group will allow the teens to graphically compare daily PA and dietary intake with the goal, participate in a reward program where they can collect virtual points for achieving the goal, and play interactive games related to PA and diet. A total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to the feasibility study (Aim 2).
Detailed Description
Using evidence to inform the design of clinical practice is a foundational principle of modern health care practice. In the present pilot study, using evidence from research on technology in clinical practice facilitated development of a hybrid intervention that combined lifestyle modification with routine clinical care. Chief among the benefits of this hybrid smartphone technology-based intervention (STB) was the potential to improve health outcomes and reduce obesity in overweight and obese adolescents. The purposes of this study were to (1) measure effects of an innovative smartphone-technology-based (STB) intervention for overweight and obese adolescents and to (2) examine the intervention's feasibility for use in primary care clinics.The STB intervention had 3 components: use of Fitbit Flex, participation in the online educational program, and receipt of bi-weekly text message during the maintenance phase. A randomized control study design was utilized. Data regard to anthropometrics (BMI and waist-hip ratio), blood pressure, levels of physical and sedentary activity, diet, and self-efficacy regarding physical activity and diet were collected at baseline, 3 month and 6 months after the baseline assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
technology, healthy weight management, primary care setting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized control study design with an active control group was used.
Masking
Care ProviderOutcomes Assessor
Masking Description
Primary care providers and outcome assessors were blinded to the group assignment.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fitbit ultra
Arm Type
Experimental
Arm 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.
Arm Title
Pedometer
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
fitbit Ultra
Other Intervention Name(s)
Fitbit Ultra and associated apps
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pedometer
Other Intervention Name(s)
Omron HJ-105 pedometer
Intervention Description
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.
Primary Outcome Measure Information:
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
Other Pre-specified Outcome Measures:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
have acute or life-threatening disease
not be able to engage in activities of daily living
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyu-Lin Chen
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF School of Nursing
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0606
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22506094
Citation
Karnik S, Kanekar A. Childhood obesity: a global public health crisis. Int J Prev Med. 2012 Jan;3(1):1-7.
Results Reference
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18407047
Citation
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Results Reference
background
PubMed Identifier
25177158
Citation
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.
Results Reference
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PubMed Identifier
21783046
Citation
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.
Results Reference
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PubMed Identifier
23308372
Citation
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.
Results Reference
background
PubMed Identifier
27621413
Citation
Sim LA, Lebow J, Wang Z, Koball A, Murad MH. Brief Primary Care Obesity Interventions: A Meta-analysis. Pediatrics. 2016 Oct;138(4):e20160149. doi: 10.1542/peds.2016-0149. Epub 2016 Sep 12.
Results Reference
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PubMed Identifier
28639320
Citation
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(6):CD012691. doi: 10.1002/14651858.CD012691.
Results Reference
background
PubMed Identifier
30409751
Citation
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.
Results Reference
result
PubMed Identifier
28768612
Citation
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.
Results Reference
derived
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iStart Smart for Teens for Healthy Weight Management
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