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

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.

Study Overview

• Status: Completed
• Conditions: Health Behavior; Motivation; Adolescent Behavior
• Intervention / Treatment: Behavioral: Zamzee Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 448
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Osos, California, United States, 93402
      • Los Osos Middle School
    • Oakland, California, United States, 94605
      • Berkley Maynard Academy
    • Oakland, California, United States, 94605
      • E.C. Reems Academy
    • Pismo Beach, California, United States, 93449
      • Judkins Middle School
    • Vista, California, United States, 92083
      • Vista Academy of Visual and Performing Arts
  • West Virginia
    • Morgantown, West Virginia, United States, 26506-6845
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Website intervention; Participants randomly assigned to the Website Intervention arm receive access to the motivational rewards website. The website displays the individual's physical activity data and allocates reward points based on the amount and intensity of physical activity. The website also allows reward points to be redeemed for various rewards such as gift cards to retail outlets, donations to charities, small tangible goods, and customization of participants' cartoon-like avatars on the website.	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.
No Intervention: Control; Participants in the control group will not have access to the motivational website. No other product or intervention will be introduced to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HopeLab Foundation
• Collaborators: West Virginia University
• Investigators: Principal Investigator: Jana Haritatos, PhD, HopeLab Foundation; Study Director: Steve Cole, PhD, HopeLab Foundation

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: September 12, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (Estimate): September 14, 2011

Study Record Updates

• Last Update Posted (Estimate): July 16, 2012
• Last Update Submitted That Met QC Criteria: July 12, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Exercise; Motivation; Biological Markers; Health Behavior; Adolescent Behavior
• Other Study ID Numbers: HLZZ-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No