ObesityNCT02507791
Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents
A study testing Fitbit Charge HR plus weekly phone calls to review physical activity data in people with Obesity, run by University Hospitals Cleveland Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Fitbit Charge HR plus weekly phone calls to review physical activity data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrollment in the Healthy Kids, Healthy Weight assessment and intervention program
- BMI greater than or equal to the 95th percentile
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UH Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Fitbit Charge HR plus weekly phone calls to review physical activity data
- Keywords
- Fitbit, Obesity, Pediatrics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Charge HR plus weekly phone calls to review physical activity dataOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Fitbit Charge HR plus weekly phone calls to review physical activity data |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score
Measured: 12 weeks
physical activity as measured by Actigraph
Measured: 12 weeks
Secondary outcomes (15)
fasting lipid panel
Measured: 12 weeks
fasting glucose
Measured: 12 weeks
fasting insulin
Measured: 12 weeks
Hemoglobin A1c
Measured: 12 weeks
Resting energy expenditure
measured using ReeVue indirect calorimeter
Measured: 12 weeks
Body composition measured by bioelectrial impedance analysis
Measured: 12 weeks
Estimation of VO2 max
Using recovery heart rate s/p 3 minute step test
Measured: 12 weeks
Blood pressure
Measured: 12 weeks
Average steps taken per day
as measured using Fitbit
Measured: Daily for 24 weeks
Resting heart rate
as measured using Fitbit
Measured: Daily for 24 weeks
Active minutes
as measured using Fitbit
Measured: Daily for 24 weeks
Minutes per day in moderate/vigorous physical heart rate range
as measured using Fitbit
Measured: Daily for 24 weeks
Physical activity self-efficiacy questionnaire
Measured: 12 weeks
Responses to sleep questionnaire
Assess subjective reports of snoring, restfulness, hours of sleep
Measured: 12 weeks
Responses to self-image questionnaire (SIQYA)
only for individuals greater than 13 years of age
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Farrell, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507791
- Sponsor's protocol ID
- 03-15-03
- Status last verified
- Jan 2022
- First submitted
- 21 Jul 2015
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fitbit Plus Weight Management Program on Physical Activity and Metabolic Disease in Obese Adolescents
- ClinicalTrials.gov ID
- NCT02507791
- Acronym / sponsor ID
- 03-15-03
- Conditions
- Obesity
- Keywords
- Fitbit, Obesity, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Fitbit | Experimental | Other: Fitbit Charge HR plus weekly phone calls to review physical activity dataPatients 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. |
| Late/Delayed Fitbit | Active comparator | Other: Fitbit Charge HR plus weekly phone calls to review physical activity dataThese 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Enrollment in the Healthy Kids, Healthy Weight assessment and intervention program
- BMI greater than or equal to the 95th percentile
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Charge HR plus weekly phone calls to review physical activity dataPatients 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 | Other | Early Fitbit, Late/Delayed Fitbit |
Primary outcome
BMI z-score
Time frame: 12 weeks
physical activity as measured by Actigraph
Time frame: 12 weeks
15 secondary outcomes
fasting lipid panel
Time frame: 12 weeks
fasting glucose
Time frame: 12 weeks
fasting insulin
Time frame: 12 weeks
Hemoglobin A1c
Time frame: 12 weeks
Resting energy expenditure
Time frame: 12 weeks
Body composition measured by bioelectrial impedance analysis
Time frame: 12 weeks
Estimation of VO2 max
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Average steps taken per day
Time frame: Daily for 24 weeks
Resting heart rate
Time frame: Daily for 24 weeks
Active minutes
Time frame: Daily for 24 weeks
Minutes per day in moderate/vigorous physical heart rate range
Time frame: Daily for 24 weeks
Physical activity self-efficiacy questionnaire
Time frame: 12 weeks
Responses to sleep questionnaire
Time frame: 12 weeks
Responses to self-image questionnaire (SIQYA)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Charge HR plus weekly phone calls to review physical activity data in people with Obesity, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.