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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Fitbit Charge HR plus weekly phone calls to review physical activity data

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UH Rainbow Babies and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Fitbit; Patients will receive Fitbit in the first phase of the study. In addition to attending weekly weight management classes, patients will wear Fitbit Charge HR devices to track heart rate, "active minutes," steps taken, calories burned, and sleep patterns. Patients will receive weekly phone calls to review this data, and further recommendations will be given to encourage additional physical activity as clinically indicated based on time spent being physically active. The goal will be for individuals to reach 10,000 steps per day, though if subjects are significantly under that goal, realistic goal-setting (recommended increases of physical activity of 10% at a time). Patients will continue this intervention for 12 weeks. After 12 weeks, they will return for reassessment. This coincides with the completion of the weight loss program. Subjects will then be followed remotely for another 12 weeks and phone call interventions will continue before returning for a final study visit.	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
Active Comparator: Late/Delayed Fitbit; These subjects will follow a similar pattern except they will not receive Fitbit Charge HR devices until the second phase of the study (specifically after completion of the 12 week weight loss program). In the first phase, these subjects will receive weekly phone calls to offer them the same attention as the experimental group, but instead of reviewing Fitbit data, these subjects will subjectively report their physical activity in minutes and by qualifying their physical activity as light, moderate, or vigorous. These individuals, after 12 weeks, will return for reassessment. At that time, these individuals will receive Fitbits and receive weekly telephone calls for an additional 12 weeks before returning for a final study visit.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
BMI z-score	12 weeks
physical activity as measured by Actigraph	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 24, 2015

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Pediatrics; Fitbit
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 03-15-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No