- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03215641
Is it Helpful to Use Fitbits in a Family Based Weight Loss Program?
December 28, 2018 updated by: Children's Hospital Los Angeles
Effect of Personal Activity Trackers on Weight Loss in Children Enrolled in a Comprehensive Behavioral Family Lifestyle Intervention (CBFLI) Program
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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.
|
|
Experimental: Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI-z score
Time Frame: Baseline to program completion (~8 weeks)
|
change in BMI-z score
|
Baseline to program completion (~8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of fitbit on program attendance
Time Frame: Baseline to program completion (~8 weeks)
|
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)
|
impact of fitbit on program completion rate
Time Frame: Baseline to program completion (~8 weeks)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relationship between change in child weight, in Kg, and daily parent steps taken as measured by the Fitbit
Time Frame: Baseline to program completion (~8 weeks
|
evaluate whether parents who are more active have children who are more likely to lose weight
|
Baseline to program completion (~8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Juan C Espinoza, MD, Children's Hospital Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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. Erratum In: Pediatrics 2002 Jun;109(6):1195.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
May 20, 2016
First Submitted That Met QC Criteria
July 10, 2017
First Posted (Actual)
July 12, 2017
Study Record Updates
Last Update Posted (Actual)
December 31, 2018
Last Update Submitted That Met QC Criteria
December 28, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHLA-15-00269
- R25DK096944 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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