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Clinical Trials/NCT01778127
NCT01778127
Completed
Not Applicable

A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer

St. Jude Children's Research Hospital1 site in 1 country105 target enrollmentFebruary 2013
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
St. Jude Children's Research Hospital
Enrollment
105
Locations
1
Primary Endpoint
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important concern. The growing population of survivors is at an increased risk of physical inactivity and associated adverse health outcomes. Regular physical activity is associated with better cardiovascular and musculoskeletal health. Despite the known benefits of physical activity, nearly half of all childhood cancer survivors do not meet recommended guidelines for physical activity.

Researchers at St. Jude Children's Research Hospital (SJCRH) want to determine if a rewards-based physical activity intervention delivered via an interactive website among young adolescent childhood cancer survivors, aged 11 through 14 years, will increase physical activity levels and improve cardiovascular and musculoskeletal health. The investigators also want to learn if this rewards-based intervention is effective. To achieve this goal the investigators have designed a three-arm prospective, randomized study with two reward-based intervention groups and a control group.

Detailed Description

PRIMARY OBJECTIVE: * To compare changes in levels of moderate and vigorous physical activity over 24 weeks. SECONDARY OBJECTIVE: * To compare changes in cardiorespiratory fitness, muscular strength and flexibility over 24 weeks. Participants will be randomized to one of three groups. Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. Participants randomized to the two intervention groups will be given access to a rewards program delivered via an interactive website, an activity monitor, and educational materials. Individual physical activity data can be viewed by study participants after uploading information from their monitors to the interactive website. One intervention group will receive minimal rewards, while the other group will receive immediate incentives as well as the minimal rewards as they move from one level to the other on the website. After 24 weeks, changes in cardiorespiratory fitness, muscular strength, flexibility, and physical function will be compared between the two intervention groups and the control group.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
April 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Previously treated for childhood cancer at St. Jude Children's Research Hospital (SJCRH)
  • 11 through 14 years of age
  • Not undergoing active treatment for cancer
  • Medical clearance from participant's attending physician via email
  • Does not meet the Centers for Disease Control (CDC) physical activity guidelines. CDC guidelines for children age 11 to 14 are defined as 60 minutes or more per day of physical activity, seven days a week
  • Internet access and a computer that has software that is compatible with the study device (Windows XP, Windows Vista, Windows 7, Mac OSX 10.5 and Mac OSX 10.6)

Exclusion Criteria

  • Global cognitive impairment (Full Scale Intelligence Quotient \< 70) that prevents use of the interactive website
  • Pregnant female
  • Inability to read and write English

Outcomes

Primary Outcomes

Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups

Time Frame: Baseline, Week 24

The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.

Secondary Outcomes

  • Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up(Baseline and 24 weeks)
  • Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second(Baseline and 24 weeks)
  • Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second(Baseline and 24 weeks)
  • Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks(Baseline and 24 weeks)
  • Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip(Baseline and 24 weeks)
  • Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup(Baseline and 24 weeks)
  • Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach(Baseline and 24 weeks)
  • Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second(Baseline and 24 weeks)
  • Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion(Baseline and 24 weeks)
  • Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second(Baseline and 24 weeks)
  • Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second(Baseline and 24 weeks)

Study Sites (1)

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