Clinical trial NCT02507791: Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents
Official title: Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Fitbit
Obesity
Pediatrics
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is evaluating the feasibility and efficacy of using Fitbit Charge HR devices to remotely track the physical activity of obese pediatric patients who are concurrently enrolled in a comprehensive weight loss intervention program. Patients will receive Fitbit devices and will be called weekly to review their average daily steps and heart rates. Patients will receive the Fitbit either at the beginning of classes or upon completion of classes. Patients will then be followed remotely and called weekly for 12 additional weeks after completing classes. The two groups will be compared to examine for differences.

Detailed description: Patients will be randomly assigned into one of two groups. In the first group, patients will undergo an already established multidisciplinary weight loss intervention program and will also wear Fitbit Charge HR devices. Their data will be regularly uploaded to their Fitbit Dashboard, and this information will be reviewed by the study team.

Eligibility criteria: Inclusion Criteria:

* Enrollment in the Healthy Kids, Healthy Weight assessment and intervention program
* BMI greater than or equal to the 95th percentile

Exclusion Criteria:

* Compromising medical condition that prevents physical activity (sickle cell disease, severe asthma, fractures, etc)
* Severe intellectual disability
* History of smoking
* Current use of atypical antipsychotics, stimulants

Primary outcomes:
measure: BMI z-score
timeFrame: 12 weeks
measure: physical activity as measured by Actigraph
timeFrame: 12 weeks
Secondary outcomes:
measure: fasting lipid panel
timeFrame: 12 weeks
measure: fasting glucose
timeFrame: 12 weeks
measure: fasting insulin
timeFrame: 12 weeks
measure: Hemoglobin A1c
timeFrame: 12 weeks
measure: Resting energy expenditure
timeFrame: 12 weeks
measure: Body composition measured by bioelectrial impedance analysis
timeFrame: 12 weeks
measure: Estimation of VO2 max
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Average steps taken per day
timeFrame: Daily for 24 weeks
measure: Resting heart rate
timeFrame: Daily for 24 weeks
measure: Active minutes
timeFrame: Daily for 24 weeks
measure: Minutes per day in moderate/vigorous physical heart rate range
timeFrame: Daily for 24 weeks
measure: Physical activity self-efficiacy questionnaire
timeFrame: 12 weeks
measure: Responses to sleep questionnaire
timeFrame: 12 weeks
measure: Responses to self-image questionnaire (SIQYA)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: UH Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
References: