iStart Smart for Teens for Healthy Weight Management

NCT ID: NCT01693250

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-12-01

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.

Conditions

Overweight; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

fitbit Ultra

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Pedometer

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Fitbit Ultra and associated apps; Omron HJ-105 pedometer

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jyu-Lin Chen

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF School of Nursing

San Francisco, California, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 22506094 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18407047 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25177158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21783046 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 23308372 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 27621413 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28639320 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30409751 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38375882 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28768612 (View on PubMed)

Other Identifiers

TEENS-2012

Identifier Type: -

Identifier Source: org_study_id