NCT02850614

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

July 26, 2016

Last Update Submit

October 9, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Physical Activity - Minutes of Moderate or Vigorous Physical Activity

    12 weeks

Secondary Outcomes (4)

  • Height

    Baseline and at 12 weeks

  • Student Engagement

    Baseline and at 12 weeks

  • Weight

    Baseline and at 12 weeks

  • BMI

    Baseline and at 12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Fifty participants in the control condition will each receive a FitBit to track their physical activity. Instead of interfacing with a gaming app on their Chromebooks to track physical activity, control condition participants will interface with a minimalist activity tracker showing them only how many minutes of MVPA they've done over the course of the day. It is expected that after several weeks of baseline use, control condition participants will no longer find the FitBit novel. In order to encourage control condition participants to wear their FitBits at school daily, they will receive one entry into a weekly lottery for each day they wear the FitBit that week.

Device: FitBit

Intervention

EXPERIMENTAL

Fifty participants will be randomized to the intervention condition, which will use a gaming application to encourage physical activity, as physical activity goal achievement will translate into rewards in the game. Physical activity will be tracked using a FitBit activity monitor and in order to encourage intervention condition participants to wear their FitBits at school daily, they will receive one entry into a weekly lottery for each day they wear the FitBit that week.

Behavioral: gaming application to encourage physical activityDevice: FitBit

Interventions

FitBitDEVICE
ControlIntervention

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age Junior or Senior at Target High School BMI \>=18.5

You may not qualify if:

  • Current participation in a formal weight-loss program Physical activity limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and DPD Director

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 1, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

Data will deposited in a repository after the study is finished.

Locations