iStart Smart for Teens for Healthy Weight Management

NCT01693250 | Completed Results

• 1 other identifier: TEENS-2012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight; Obese

Keywords

technology; healthy weight management; primary care setting

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Diastolic Blood Pressure

  baseline and 6 months

Study Arms (2)

fitbit ultra

EXPERIMENTAL

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

Pedometer

ACTIVE COMPARATOR

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.

Behavioral: Pedometer

Interventions

fitbit Ultra BEHAVIORAL

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.

Also known as: Fitbit Ultra and associated apps

fitbit ultra

Pedometer BEHAVIORAL

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.

Also known as: Omron HJ-105 pedometer

Pedometer

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• have acute or life-threatening disease
• not be able to engage in activities of daily living

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF School of Nursing

San Francisco, California, 94143-0606, United States

Location

Related Publications (10)

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

  PMID: 22506094 BACKGROUND

• 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.

  PMID: 18407047 BACKGROUND

• 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.

  PMID: 25177158 BACKGROUND

• 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.

  PMID: 21783046 BACKGROUND

• 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.

  PMID: 23308372 BACKGROUND

• 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.

  PMID: 27621413 BACKGROUND

• 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.

  PMID: 28639320 BACKGROUND

• 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.

  PMID: 30409751 RESULT

• Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

  PMID: 38375882 DERIVED

• 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.

  PMID: 28768612 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jyu-Lin Chen
• Organization: University of California San Francisco

jyu-lin.chen@ucsf.edu

415-502-6015

Study Officials

• Jyu-Lin Chen

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Primary care providers and outcome assessors were blinded to the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized control study design with an active control group was used.

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 26, 2012
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 20, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)