Obesity Clinical Trial
NCT number | NCT02850614 |
Other study ID # | 16-080 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | May 2018 |
Verified date | October 2018 |
Source | University of Vermont |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Juniors and seniors will be recruited to participate in the study, which will begin in the fall 2016 and run through May. The intervention will be a randomized-controlled trial, where students are randomized to either a control or incentive condition. Physical activity will be automatically tracked throughout the study period using FitBit activity trackers wirelessly linked to the gaming application on students' Chromebooks or mobile phones. Students who achieve 30 minutes of MVPA during the school day and/or 60 minutes of MVPA over the entire day will receive in-game rewards moving them up leaderboards in the game, providing them with more game points, or allowing them access to more game elements. Baseline outcome measures will be collected at the beginning of the school year in the fall, and post-intervention outcome measures will be collected in May.
Status | Completed |
Enrollment | 105 |
Est. completion date | May 2018 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 18 Years |
Eligibility |
Inclusion Criteria: - 15-18 years of age Junior or Senior at Target High School BMI >=18.5 Exclusion Criteria: - Current participation in a formal weight-loss program Physical activity limitations |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont | GameTheory |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Activity - Steps | The primary measurement tool for physical activity will be the use of FitBits to quantify the number of minutes students are moving each day, and the number of steps they are taking. Even the most basic FitBits capture steps, distance, minutes people are active each day, and intensity of activity. They are then able to wirelessly sync with the study database and gaming application (intervention condition) or tracking application (control condition), so accounting for activity will be automatic. FitBits have been validated as an acceptable measurement tool for measuring physical activity in free-living individuals.48 It is anticipated that most physical activity students engage in would be traceable with the FitBit. Physical activity in both the control and intervention conditions will be continuously tracked throughout the baseline, intervention, and post-intervention periods. | 12 weeks | |
Primary | Physical Activity - Minutes of Moderate or Vigorous Physical Activity | 12 weeks | ||
Secondary | Height | Baseline and at 12 weeks | ||
Secondary | Student Engagement | Student engagement will be assessed at baseline and post-intervention using a self-administered previously established student engagement scale assessing student connectedness and whole-school connectedness. The scale was developed by Bradshaw et al., as part of the Maryland Safe and Supportive School Climate Survey.49 This scale includes 9-items with 4-point Likert scale response options. | Baseline and at 12 weeks | |
Secondary | Weight | Baseline and at 12 weeks | ||
Secondary | BMI | Baseline and at 12 weeks |
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