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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit Charge HR plus weekly phone calls to review physical activity data
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Fitbit, Obesity, Pediatrics

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UH Rainbow Babies and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Fitbit

Late/Delayed Fitbit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

BMI z-score
physical activity as measured by Actigraph

Secondary Outcome Measures

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

Full Information

First Posted
July 21, 2015
Last Updated
January 31, 2022
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02507791
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Fitbit, Obesity, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Fitbit
Arm Type
Experimental
Arm Description
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.
Arm Title
Late/Delayed Fitbit
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fitbit Charge HR plus weekly phone calls to review physical activity data
Intervention Description
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
Primary Outcome Measure Information:
Title
BMI z-score
Time Frame
12 weeks
Title
physical activity as measured by Actigraph
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
fasting lipid panel
Time Frame
12 weeks
Title
fasting glucose
Time Frame
12 weeks
Title
fasting insulin
Time Frame
12 weeks
Title
Hemoglobin A1c
Time Frame
12 weeks
Title
Resting energy expenditure
Description
measured using ReeVue indirect calorimeter
Time Frame
12 weeks
Title
Body composition measured by bioelectrial impedance analysis
Time Frame
12 weeks
Title
Estimation of VO2 max
Description
Using recovery heart rate s/p 3 minute step test
Time Frame
12 weeks
Title
Blood pressure
Time Frame
12 weeks
Title
Average steps taken per day
Description
as measured using Fitbit
Time Frame
Daily for 24 weeks
Title
Resting heart rate
Description
as measured using Fitbit
Time Frame
Daily for 24 weeks
Title
Active minutes
Description
as measured using Fitbit
Time Frame
Daily for 24 weeks
Title
Minutes per day in moderate/vigorous physical heart rate range
Description
as measured using Fitbit
Time Frame
Daily for 24 weeks
Title
Physical activity self-efficiacy questionnaire
Time Frame
12 weeks
Title
Responses to sleep questionnaire
Description
Assess subjective reports of snoring, restfulness, hours of sleep
Time Frame
12 weeks
Title
Responses to self-image questionnaire (SIQYA)
Description
only for individuals greater than 13 years of age
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
UH Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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

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