NCT03215641

Brief Summary

This study evaluates the role of personal activity trackers to help improve weight loss or weight maintenance for children and their parents enrolled in a comprehensive weight loss program.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

3.6 years

First QC Date

May 20, 2016

Last Update Submit

December 28, 2018

Conditions

Pediatric Obesity

Keywords

obesitypediatricsweight management programFitbitpersonal activity tracker

Outcome Measures

Primary Outcomes (1)

  • BMI-z score

    change in BMI-z score

    Baseline to program completion (~8 weeks)

Secondary Outcomes (2)

  • Impact of fitbit on program attendance

    Baseline to program completion (~8 weeks)

  • impact of fitbit on program completion rate

    Baseline to program completion (~8 weeks)

Other Outcomes (1)

  • relationship between change in child weight, in Kg, and daily parent steps taken as measured by the Fitbit

    Baseline to program completion (~8 weeks

Study Arms (2)

Control

NO INTERVENTION

The control group families will participate in the standard Body Works weight loss program. They will fill out brief surveys regarding their physical activity on a weekly basis, but otherwise will receive the standard curriculum. they will receive weekly feedback based on their physical activity surveys.

Intervention

EXPERIMENTAL

The intervention group families will be given fitbits on the first day of the Body Works program. They will otherwise receive the same curriculum as the control families. the will fill out the same physical activity surveys as the control families. they will receive weekly feedback based on the objectively measured physical activity.

Device: Fitbit

Interventions

FitbitDEVICE

The Fitbit is a consumer-grade personal activity tracker. It is used to track physical activity. Patients will be given devices at the beginning of the study, and they will continue to use it for 7 weeks. Their data will be collected on a weekly basis, and patients will receive feedback on their level of activity based on the Fitbit data.

Intervention

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Unable to wear PAT as described in study protocol Unwilling to wear PAT Unwilling to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Wang G, Dietz WH. Economic burden of obesity in youths aged 6 to 17 years: 1979-1999. Pediatrics. 2002 May;109(5):E81-1. doi: 10.1542/peds.109.5.e81.

    PMID: 11986487BACKGROUND

  • Janicke DM, Steele RG, Gayes LA, Lim CS, Clifford LM, Schneider EM, Carmody JK, Westen S. Systematic review and meta-analysis of comprehensive behavioral family lifestyle interventions addressing pediatric obesity. J Pediatr Psychol. 2014 Sep;39(8):809-25. doi: 10.1093/jpepsy/jsu023. Epub 2014 May 13.

    PMID: 24824614BACKGROUND

  • Troiano RP, McClain JJ, Brychta RJ, Chen KY. Evolution of accelerometer methods for physical activity research. Br J Sports Med. 2014 Jul;48(13):1019-23. doi: 10.1136/bjsports-2014-093546. Epub 2014 Apr 29.

    PMID: 24782483BACKGROUND

  • Buttitta M, Iliescu C, Rousseau A, Guerrien A. Quality of life in overweight and obese children and adolescents: a literature review. Qual Life Res. 2014 May;23(4):1117-39. doi: 10.1007/s11136-013-0568-5. Epub 2013 Nov 19.

    PMID: 24249217BACKGROUND

  • Guinhouya BC, Samouda H, de Beaufort C. Level of physical activity among children and adolescents in Europe: a review of physical activity assessed objectively by accelerometry. Public Health. 2013 Apr;127(4):301-11. doi: 10.1016/j.puhe.2013.01.020. Epub 2013 Apr 10.

    PMID: 23582270BACKGROUND

  • Lytle LA. Dealing with the childhood obesity epidemic: a public health approach. Abdom Imaging. 2012 Oct;37(5):719-24. doi: 10.1007/s00261-012-9861-y.

    PMID: 22395212BACKGROUND

  • Trasande L, Elbel B. The economic burden placed on healthcare systems by childhood obesity. Expert Rev Pharmacoecon Outcomes Res. 2012 Feb;12(1):39-45. doi: 10.1586/erp.11.93.

    PMID: 22280195BACKGROUND

  • Wilks DC, Besson H, Lindroos AK, Ekelund U. Objectively measured physical activity and obesity prevention in children, adolescents and adults: a systematic review of prospective studies. Obes Rev. 2011 May;12(5):e119-29. doi: 10.1111/j.1467-789X.2010.00775.x.

    PMID: 20604868BACKGROUND

  • Whitlock EP, O'Connor EA, Williams SB, Beil TL, Lutz KW. Effectiveness of weight management interventions in children: a targeted systematic review for the USPSTF. Pediatrics. 2010 Feb;125(2):e396-418. doi: 10.1542/peds.2009-1955. Epub 2010 Jan 18.

    PMID: 20083531BACKGROUND

  • Trasande L, Chatterjee S. The impact of obesity on health service utilization and costs in childhood. Obesity (Silver Spring). 2009 Sep;17(9):1749-54. doi: 10.1038/oby.2009.67. Epub 2009 Mar 19.

    PMID: 19300433BACKGROUND

  • Oude Luttikhuis H, Baur L, Jansen H, Shrewsbury VA, O'Malley C, Stolk RP, Summerbell CD. Interventions for treating obesity in children. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001872. doi: 10.1002/14651858.CD001872.pub2.

    PMID: 19160202BACKGROUND

  • Finkelstein EA, Trogdon JG. Public health interventions for addressing childhood overweight: analysis of the business case. Am J Public Health. 2008 Mar;98(3):411-5. doi: 10.2105/AJPH.2007.114991. Epub 2008 Jan 30.

    PMID: 18235061BACKGROUND

  • Espinoza JC, Deavenport-Saman A, Solomon O, Chowdhuri S, Wee CP, Azen C, Orozco J, Kreutzer C, Yin L. Not just at school: Inclusion of children with autism spectrum disorder in a weight management program in a community pediatric setting. Autism. 2021 Apr;25(3):642-655. doi: 10.1177/1362361321993710. Epub 2021 Feb 24.

    PMID: 33626921DERIVED

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juan C Espinoza, MD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

July 12, 2017

Study Start

August 1, 2015

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

December 31, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share