The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents

Health Behavior Clinical Trial

Official title:

The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433679
• Other study ID #: HLZZ-001
• Status: Completed
• Phase: N/A
• First received: September 12, 2011
• Last updated: July 12, 2012
• Start date: September 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• 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 purpose of this study is to test whether rewarding physical activity with a motivational website will increase physical activity levels in middle school-aged children over six months. As a secondary outcome, the study also tests the intervention's impact on biological measures of inflammation and metabolic function in a sub-set of study participants who agree to provide blood samples.

Description:

Physical activity is associated with a variety of positive health outcomes, as well as improved metabolic profiles and reduced inflammation. However, levels of moderate to vigorous physical activity (MVPA) diminish dramatically as children move into the middle school years. To address this problem, this study tests a behavioral intervention, called "Zamzee," designed to motivate middle school-aged children to increase their levels of MVPA. The Zamzee intervention consists of a 3-axis accelerometer that tracks individual physical activity rates over time and a website that displays individual physical activity rates and provides rewards for maintaining or improving physical activity rates. The primary aim of this randomized, controlled trial is to test whether middle school-aged children randomly assigned to the Zamzee intervention will show significantly greater levels of physical activity levels over six months, compared with control group participants who wear the accelerometer but have no access to the rewards website. A secondary aim is to test the intervention's impact on biological parameters that may contribute to the long-term health effects of inactivity (including C-reactive protein as a measure of inflammation, and hemoglobin-A1C as a measure of metabolic status) in a sub-set of study participants who agree to provide blood samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 14 Years

Eligibility

Inclusion Criteria:

• Middle-school-aged students aged 11 to 14

Exclusion Criteria:

• Previously participation in a Zamzee pilot study

• Existing medical conditions or health complications that will interfere with the ability to be physically active

• Inability to read and write English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Behavior
• Health Behavior
• Motivation

Intervention

Behavioral:
• Zamzee Intervention
The Zamzee intervention is designed to motivate middle school-aged children to increase their rates of moderate to vigorous physical activity (MVPA) by providing rewards based on amount and duration of physical activity. Rewards include gift cards to retail stores, donations to charity, small tangible goods, and customization of their cartoon-like avatars on the website.

Locations

Country	Name	City	State
United States	Los Osos Middle School	Los Osos	California
United States	West Virginia University	Morgantown	West Virginia
United States	Berkley Maynard Academy	Oakland	California
United States	E.C. Reems Academy	Oakland	California
United States	Judkins Middle School	Pismo Beach	California
United States	Vista Academy of Visual and Performing Arts	Vista	California

Sponsors (2)

Lead Sponsor	Collaborator
HopeLab Foundation	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 their accelerometer for the duration of the six month study. The primary outcome reported will be rates of "moderate to vigorous physical activity" as defined by the CDC.	Six months	No
Secondary	Metabolic and inflammatory biomarkers	In the subset of study participants who agree to provide blood samples, blood samples collected at study baseline and at the six month study completion will be assayed for measures of inflammation (e.g., C-reactive protein) and metabolic function (e.g.,hemoglobin-A1C).	Six months	No