Clinical trial NCT01433679: The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents
Official title: The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Adolescent Behavior
Motivation
Keywords: Health Behavior
Exercise
Adolescent Behavior
Motivation
Biological Markers
Lead sponsor: HopeLab Foundation
Sponsor class: OTHER
Collaborators: name: West Virginia University
First posted: 2011-09-14
Enrollment: 448
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity
timeFrame: Six months
Secondary outcomes:
measure: Metabolic and inflammatory biomarkers
timeFrame: Six months
Other outcomes:
Locations:
city: Los Osos
country: United States
facility: Los Osos Middle School
state: California
city: Oakland
country: United States
facility: Berkley Maynard Academy
state: California
city: Oakland
country: United States
facility: E.C. Reems Academy
state: California
city: Pismo Beach
country: United States
facility: Judkins Middle School
state: California
city: Vista
country: United States
facility: Vista Academy of Visual and Performing Arts
state: California
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: HopeLab Foundation
name: Jana Haritatos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HopeLab Foundation
name: Steve Cole, PhD
role: STUDY_DIRECTOR
References: