Is it Helpful to Use Fitbits in a Family Based Weight Loss Program?

Pediatric Obesity Clinical Trial

Official title:

Effect of Personal Activity Trackers on Weight Loss in Children Enrolled in a Comprehensive Behavioral Family Lifestyle Intervention (CBFLI) Program

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03215641
• Other study ID #: CHLA-15-00269
• Secondary ID: R25DK096944
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 2015
• Est. completion date: March 2019

Study information

• Verified date: December 2018
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Childhood obesity rates have tripled in the last 30 years, with as many as 50% of children in the US being obese or overweight. High-intensity comprehensive behavioral family lifestyle intervention (CBFLI) programs have been shown to be among the most effective interventions for weight loss in children. However, these programs are time- and resource-intensive with high rates of recidivism. Personal activity trackers (PAT) provide objectively measured physical activity data and are more reliable than self-report. These devices can also have a motivational impact. The investigators intend to study the effects of these devices and their data on behavior change and weight loss for both parents and children enrolled in a CBFLI program. The investigators will objectively measure the level of activity of both members of the parent-child dyad, explore the relationship between parent-child activity levels and its effect on each other, as well as on overall weight loss or weight maintenance.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• All individuals enrolled in BodyWorks who are at least 7 years old meet inclusion criteria for this study. there is no maximum age for participation.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pediatric Obesity
• Weight Loss

Intervention

Device:
• Fitbit
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	Academic Pediatric Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Lytle LA. Dealing with the childhood obesity epidemic: a public health approach. Abdom Imaging. 2012 Oct;37(5):719-24. Review. — View Citation

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. Review. — View Citation

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. Erratum in: Obesity (Silver Spring). 2009 Jul;17(7):1473. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Wang G, Dietz WH. Economic burden of obesity in youths aged 6 to 17 years: 1979-1999. Pediatrics. 2002 May;109(5):E81-1. Erratum in: Pediatrics 2002 Jun;109(6):1195. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	relationship between change in child weight, in Kg, and daily parent steps taken as measured by the Fitbit	evaluate whether parents who are more active have children who are more likely to lose weight	Baseline to program completion (~8 weeks
Primary	BMI-z score	change in BMI-z score	Baseline to program completion (~8 weeks)
Secondary	Impact of fitbit on program attendance	The investigators will evaluate if families that receive fitbits attend more sessions (out of 7 total sessions) by recording their attendance at each session	Baseline to program completion (~8 weeks)
Secondary	impact of fitbit on program completion rate	The investigators will evaluate if families that receive fitbits complete the program at a higher rate (completion is defined as having attended at least 4 out of 7 sessions).	Baseline to program completion (~8 weeks)