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

This study has been completed.
Sponsor:
Collaborator:
West Virginia University
Information provided by (Responsible Party):
HopeLab Foundation
ClinicalTrials.gov Identifier:
NCT01433679
First received: September 12, 2011
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Health Behavior
Adolescent Behavior
Motivation
Behavioral: Zamzee Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents

Resource links provided by NLM:


Further study details as provided by HopeLab Foundation:

Primary Outcome Measures:
  • Physical activity [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Metabolic and inflammatory biomarkers [ Time Frame: Six months ] [ Designated as safety issue: No ]
    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).


Enrollment: 448
Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433679

Locations
United States, California
Los Osos Middle School
Los Osos, California, United States, 93402
Berkley Maynard Academy
Oakland, California, United States, 94605
E.C. Reems Academy
Oakland, California, United States, 94605
Judkins Middle School
Pismo Beach, California, United States, 93449
Vista Academy of Visual and Performing Arts
Vista, California, United States, 92083
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506-6845
Sponsors and Collaborators
HopeLab Foundation
West Virginia University
Investigators
Principal Investigator: Jana Haritatos, PhD HopeLab Foundation
Study Director: Steve Cole, PhD HopeLab Foundation
  More Information

No publications provided

Responsible Party: HopeLab Foundation
ClinicalTrials.gov Identifier: NCT01433679     History of Changes
Other Study ID Numbers: HLZZ-001
Study First Received: September 12, 2011
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by HopeLab Foundation:
Health Behavior
Exercise
Adolescent Behavior
Motivation
Biological Markers

ClinicalTrials.gov processed this record on October 23, 2014