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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507791
• Other study ID #: 03-15-03
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 2016

Study information

• Verified date: January 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Obesity

Intervention

Other:
• Fitbit Charge HR plus weekly phone calls to review physical activity data
Patients during weekly Healthy Kids, Healthy Weight classes will also upload their Fitbit data, which will be remotely accessed by the study team and weekly phone calls will be implemented to discuss activity

Locations

Country	Name	City	State
United States	UH Rainbow Babies and Children's Hospital	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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