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

Primary Purpose

Pediatric Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fitbit
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring obesity, pediatrics, weight management program, Fitbit, personal activity tracker

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    BMI-z score
    change in BMI-z score

    Secondary Outcome Measures

    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
    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).

    Full Information

    First Posted
    May 20, 2016
    Last Updated
    December 28, 2018
    Sponsor
    Children's Hospital Los Angeles
    Collaborators
    Academic Pediatric Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03215641
    Brief Title
    Is it Helpful to Use Fitbits in a Family Based Weight Loss Program?
    Official Title
    Effect of Personal Activity Trackers on Weight Loss in Children Enrolled in a Comprehensive Behavioral Family Lifestyle Intervention (CBFLI) Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    March 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital Los Angeles
    Collaborators
    Academic Pediatric Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Obesity
    Keywords
    obesity, pediatrics, weight management program, Fitbit, personal activity tracker

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Fitbit
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    BMI-z score
    Description
    change in BMI-z score
    Time Frame
    Baseline to program completion (~8 weeks)
    Secondary Outcome Measure Information:
    Title
    Impact of fitbit on program attendance
    Description
    The investigators will evaluate if families that receive fitbits attend more sessions (out of 7 total sessions) by recording their attendance at each session
    Time Frame
    Baseline to program completion (~8 weeks)
    Title
    impact of fitbit on program completion rate
    Description
    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).
    Time Frame
    Baseline to program completion (~8 weeks)
    Other Pre-specified Outcome Measures:
    Title
    relationship between change in child weight, in Kg, and daily parent steps taken as measured by the Fitbit
    Description
    evaluate whether parents who are more active have children who are more likely to lose weight
    Time Frame
    Baseline to program completion (~8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan C Espinoza, MD
    Organizational Affiliation
    Children's Hospital Los Angeles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11986487
    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. doi: 10.1542/peds.109.5.e81. Erratum In: Pediatrics 2002 Jun;109(6):1195.
    Results Reference
    background
    PubMed Identifier
    24824614
    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.
    Results Reference
    background
    PubMed Identifier
    24782483
    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.
    Results Reference
    background
    PubMed Identifier
    24249217
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23582270
    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.
    Results Reference
    background
    PubMed Identifier
    22395212
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22280195
    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.
    Results Reference
    background
    PubMed Identifier
    20604868
    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.
    Results Reference
    background
    PubMed Identifier
    20083531
    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.
    Results Reference
    background
    PubMed Identifier
    19300433
    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.
    Results Reference
    background
    PubMed Identifier
    19160202
    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.
    Results Reference
    background
    PubMed Identifier
    18235061
    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.
    Results Reference
    background
    PubMed Identifier
    33626921
    Citation
    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.
    Results Reference
    derived

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