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

NCT ID: NCT03215641

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Pediatric Obesity

Keywords

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obesity pediatrics weight management program Fitbit personal activity tracker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Fitbit

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

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

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Academic Pediatric Association

INDUSTRY

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan C Espinoza, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

References

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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 24824614 (View on PubMed)

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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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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.

Reference Type DERIVED
PMID: 33626921 (View on PubMed)

Other Identifiers

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R25DK096944

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHLA-15-00269

Identifier Type: -

Identifier Source: org_study_id