Clinical trial NCT03215641: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Keywords: obesity
pediatrics
weight management program
Fitbit
personal activity tracker
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: Academic Pediatric Association
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: BMI-z score
timeFrame: Baseline to program completion (~8 weeks)
Secondary outcomes:
measure: Impact of fitbit on program attendance
timeFrame: Baseline to program completion (~8 weeks)
measure: impact of fitbit on program completion rate
timeFrame: Baseline to program completion (~8 weeks)
Other outcomes:
measure: relationship between change in child weight, in Kg, and daily parent steps taken as measured by the Fitbit
timeFrame: Baseline to program completion (~8 weeks
Locations:
Study officials:
affiliation: Children's Hospital Los Angeles
name: Juan C Espinoza, MD
role: PRINCIPAL_INVESTIGATOR
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