Obesity
Conditions
Keywords
Fitbit, Obesity, Pediatrics
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.
Interventions
OTHERFitbit 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
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI z-score | 12 weeks |
| physical activity as measured by Actigraph | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active minutes | Daily for 24 weeks | as measured using Fitbit |
| Minutes per day in moderate/vigorous physical heart rate range | Daily for 24 weeks | as measured using Fitbit |
| Physical activity self-efficiacy questionnaire | 12 weeks | — |
| Responses to sleep questionnaire | 12 weeks | Assess subjective reports of snoring, restfulness, hours of sleep |
| fasting lipid panel | 12 weeks | — |
| fasting glucose | 12 weeks | — |
| Average steps taken per day | Daily for 24 weeks | as measured using Fitbit |
| Hemoglobin A1c | 12 weeks | — |
| Resting energy expenditure | 12 weeks | measured using ReeVue indirect calorimeter |
| Body composition measured by bioelectrial impedance analysis | 12 weeks | — |
| Estimation of VO2 max | 12 weeks | Using recovery heart rate s/p 3 minute step test |
| Blood pressure | 12 weeks | — |
| Responses to self-image questionnaire (SIQYA) | 12 weeks | only for individuals greater than 13 years of age |
| fasting insulin | 12 weeks | — |
| Resting heart rate | Daily for 24 weeks | as measured using Fitbit |
Countries
United States
Outcome results
None listed