Health Behavior Clinical Trial
Official title:
The Effect of a Web-Based Behavioral Intervention on Physical Activity Levels in Adolescents
Verified date | July 2012 |
Source | HopeLab Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
HopeLab Foundation | West Virginia University |
United States,
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 |
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