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OpenTrials
Completed

NCT Number: NCT02507791

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

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.

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Key information

Conditions

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

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. BMI z-score

    Time frame: 12 weeks

  2. physical activity as measured by Actigraph

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2015
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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