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

NCT02507791 | Completed

• 1 other identifier: 03-15-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Fitbit; Obesity; Pediatrics

Outcome Measures

Primary Outcomes (2)

• BMI z-score

  12 weeks

• physical activity as measured by Actigraph

  12 weeks

Secondary Outcomes (15)

• fasting lipid panel

  12 weeks

• fasting glucose

  12 weeks

• fasting insulin

  12 weeks

• Hemoglobin A1c

  12 weeks

• Resting energy expenditure

  12 weeks

Study Arms (2)

Early Fitbit

EXPERIMENTAL

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

Late/Delayed Fitbit

ACTIVE COMPARATOR

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

Interventions

Fitbit Charge HR plus weekly phone calls to review physical activity data OTHER

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

Early Fitbit; Late/Delayed Fitbit

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

UH Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 24, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 15, 2022

Record last verified: 2022-01

Locations

US (1)