NCT02425384

Brief Summary

The primary objective of this protocol is to test whether an activity monitor with an online motivational rewards component will increase physical activity levels of middle school-aged students. The secondary objective is to learn about the functionality and utilization of the activity meter device among this age group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

April 16, 2015

Last Update Submit

April 23, 2015

Conditions

Keywords

adolescentphysical activityaccelerometer

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    The amount and intensity of physical activity is recorded continuously every study day that participants wear the provided activity meter for the 6 weeks study. The primary outcome reported will be rates of "moderate to vigorous" physical activity.

    6 weeks

Study Arms (3)

Intervention Group

EXPERIMENTAL

This group is provided an activity meter that tracks the amount and intensity of one's physical activity and is linked to a motivational website. On the website, activity data from the activity meter can be viewed after uploading information from the meter to the website. The reward website allots points for participants based on the amount and intensity of physical activity. Points can be redeemed for rewards on the website, such as gift cards and digital badges.

Behavioral: Intervention Group (motivational website, activity meter)

Active Control

ACTIVE COMPARATOR

This group is provided an activity meter that tracks the amount and intensity of one's physical activity and a copy of the game Dance Dance Revolution (DDR). The activity meter will upload data to a secure server but will not be linked to the motivational website used by the intervention group. DDR is a dancing video game in which players view arrows timed to music on a TV screen and gain points by stepping on the corresponding arrows on a floor mat. Players obtain points in the game by stepping on the correct arrows at the right time to the beat of the music. The points earned with DDR cannot be redeemed for rewards.

Behavioral: Active Control (active video game, activity meter)

Passive Control

PLACEBO COMPARATOR

This group is provided with an activity meter and will be asked to carry it with them as they go about their normal daily activities. Like in the Active Control group, participants in the Passive Control group will not have access to the motivational website. For this group, the activity meter functions solely as a monitor to track their activity levels. No other product or intervention will be introduced to the control group.

Other: Passive Control (activity meter)

Interventions

The activity meter linked to a motivational website is designed to motivate middle school-aged children to increase their rates of physical activity by providing feedback on the amount of activity, and rewards based on the amount and duration of activity.

Intervention Group

The active video game, Dance Dance Revolution, requires physical movement as part of game play and may motivate users to engage in more activity. The same activity meter used in the Intervention Group is provided to this group to track physical activity but does not link to the motivational website nor does it provide any feedback on levels or duration of activity.

Active Control

Participants are provided the same activity meter used in the other study groups to track physical activity but it does not link to the motivational website nor does it provide any feedback on levels or duration of activity. Participants are asked to go about their normal activities.

Passive Control

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any student 11 to 14 years old with access to a computer that uses either Windows XP or Mac OS X 10.4 operating system with internet access.

You may not qualify if:

  • Anyone with a medical condition or existing health complications that will interfere with their ability to be physically active.
  • Inability to read and write English (though consent forms for parents that speak other languages will be provided).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Crittenden Middle School

Mountain View, California, 94043, United States

Location

Vista Middle School

Vista, California, 92083, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Health BehaviorAdolescent BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Steven Cole, PhD

    HopeLab Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 24, 2015

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations