iStart Smart for Teens for Healthy Weight Management

Overweight Clinical Trial

Official title:

Phase 1 Study of Fitbit and Apps on Healthy Weight Management in Obese Teens in Primary Care Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693250
• Other study ID #: TEENS-2012
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 1, 2016

Study information

• Verified date: August 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCSF School of Nursing	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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.20 — View 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. — View 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. Review. — View 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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diastolic Blood Pressure	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.	baseline and 6 months
Primary	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%.	baseline and 6 months