Accelerometer-linked Online Intervention to Promote Physical Activity in Adolescents

Health Behavior Clinical Trial

Official title:

Accelerometer-linked Online Intervention to Promote Physical Activity in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425384
• Other study ID #: HL-GD001
• Status: Completed
• Phase: N/A
• First received: April 16, 2015
• Last updated: April 23, 2015
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: April 2015
• Source: HopeLab Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The goal of this pilot study is to find out whether an activity meter linked to web-based rewards will increase physical activity levels in middle school aged students who use it over 6 weeks. To test this, students who participate in the study will be assigned to 1 of 3 groups: the meter with web-based rewards group, the Dance Dance Revolution group, or the control group. The physical activity of participants in all 3 groups will be tracked using the an activity meter that participants will be asked to carry daily for the 6 weeks of the study. Participants given the activity meter with web-based rewards or Dance Dance Revolution will be instructed to use them at their own will, as much or as little as they like. Before beginning the study, all participating students will be asked background questions about themselves (such as their gender, age, and ethnic group) and about the kinds of computer and video game consoles they have access to at home. All participants will also complete short questionnaires at enrollment, week 1, week 3 and week 6. These questions will ask participants about their experiences using the assigned devices, their physical activity levels, and their thoughts about their ability to be physically active. At the end of 6 weeks, all participants will finish the study and return their assigned devices to the study coordinator. Height and weight will be measured at baseline and at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Adolescent Behavior
• Health Behavior
• Motivation

Intervention

Behavioral:
• Intervention Group (motivational website, activity meter)
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.
• Active Control (active video game, activity meter)
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.

Other:
• Passive Control (activity meter)
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.

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia
United States	Crittenden Middle School	Mountain View	California
United States	Vista Middle School	Vista	California

Sponsors (4)

Lead Sponsor	Collaborator
HopeLab Foundation	Santech, Inc, Stanford University, West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No