Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT02507791
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-24
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
BMI z-score	12 weeks
physical activity as measured by Actigraph	12 weeks

Secondary Outcome Measures

Name	Time	Method
fasting lipid panel	12 weeks
Estimation of VO2 max	12 weeks	Using recovery heart rate s/p 3 minute step test
Responses to self-image questionnaire (SIQYA)	12 weeks	only for individuals greater than 13 years of age
Body composition measured by bioelectrial impedance analysis	12 weeks
Minutes per day in moderate/vigorous physical heart rate range	Daily for 24 weeks	as measured using Fitbit
fasting glucose	12 weeks
Hemoglobin A1c	12 weeks
Resting energy expenditure	12 weeks	measured using ReeVue indirect calorimeter
Average steps taken per day	Daily for 24 weeks	as measured using Fitbit
fasting insulin	12 weeks
Responses to sleep questionnaire	12 weeks	Assess subjective reports of snoring, restfulness, hours of sleep
Resting heart rate	Daily for 24 weeks	as measured using Fitbit
Active minutes	Daily for 24 weeks	as measured using Fitbit
Physical activity self-efficiacy questionnaire	12 weeks
Blood pressure	12 weeks

Trial Locations

Locations (1)

UH Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States