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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02507791
Recruitment Status : Unknown
Verified July 2015 by Ryan Farrell, University Hospitals Cleveland Medical Center.
Recruitment status was:  Recruiting
First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Sponsor:
Collaborators:
Sovereign Order of St. John
Department of Pediatric Endocrinology and Metabolism
Healthy Kids, Healthy Weight
Center for Child Health and Advocacy
Information provided by (Responsible Party):
Ryan Farrell, 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.

Condition or disease Intervention/treatment Phase
Obesity Other: Fitbit Charge HR plus weekly phone calls to review physical activity data Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents
Study Start Date : May 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. BMI z-score [ Time Frame: 12 weeks ]
  2. physical activity as measured by Actigraph [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. fasting lipid panel [ Time Frame: 12 weeks ]
  2. fasting glucose [ Time Frame: 12 weeks ]
  3. fasting insulin [ Time Frame: 12 weeks ]
  4. Hemoglobin A1c [ Time Frame: 12 weeks ]
  5. Resting energy expenditure [ Time Frame: 12 weeks ]
    measured using ReeVue indirect calorimeter

  6. Body composition measured by bioelectrial impedance analysis [ Time Frame: 12 weeks ]
  7. Estimation of VO2 max [ Time Frame: 12 weeks ]
    Using recovery heart rate s/p 3 minute step test

  8. Blood pressure [ Time Frame: 12 weeks ]
  9. Average steps taken per day [ Time Frame: Daily for 24 weeks ]
    as measured using Fitbit

  10. Resting heart rate [ Time Frame: Daily for 24 weeks ]
    as measured using Fitbit

  11. Active minutes [ Time Frame: Daily for 24 weeks ]
    as measured using Fitbit

  12. Minutes per day in moderate/vigorous physical heart rate range [ Time Frame: Daily for 24 weeks ]
    as measured using Fitbit

  13. Physical activity self-efficiacy questionnaire [ Time Frame: 12 weeks ]
  14. Responses to sleep questionnaire [ Time Frame: 12 weeks ]
    Assess subjective reports of snoring, restfulness, hours of sleep

  15. Responses to self-image questionnaire (SIQYA) [ Time Frame: 12 weeks ]
    only for individuals greater than 13 years of age



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507791


Contacts
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Contact: Ryan M Farrell, MD 216-844-3661 ryan.farrell@uhhospitals.org

Locations
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United States, Ohio
UH Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Ryan M Farrell, MD    216-844-3661    ryan.farrell@uhhospitals.org   
Contact: Naveen Uli, MD    216-844-3661    Naveen.Uli1@uhhospitals.org   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Sovereign Order of St. John
Department of Pediatric Endocrinology and Metabolism
Healthy Kids, Healthy Weight
Center for Child Health and Advocacy
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Responsible Party: Ryan Farrell, Fellow, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02507791    
Other Study ID Numbers: 03-15-03
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015
Keywords provided by Ryan Farrell, University Hospitals Cleveland Medical Center:
Fitbit
Obesity
Pediatrics
Additional relevant MeSH terms:
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Metabolic Diseases