A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Global cognitive impairment (Full Scale Intelligence Quotient < 70) that prevents use of the interactive website
- •Pregnant female
- •Inability to read and write English
研究组 & 干预措施
Group A: Minimal Rewards
Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
干预措施: Activity Monitor (Behavioral)
Group A: Minimal Rewards
Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
干预措施: Interactive Website (Behavioral)
Group B: Immediate Incentives
Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
干预措施: Interactive Website (Behavioral)
Group A: Minimal Rewards
Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.
干预措施: Educational Materials (Behavioral)
Group B: Immediate Incentives
Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
干预措施: Activity Monitor (Behavioral)
Group B: Immediate Incentives
Participants use an activity monitor and the interactive website.
In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.
干预措施: Educational Materials (Behavioral)
Group C: Control
Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
干预措施: Activity Monitor (Behavioral)
Group C: Control
Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.
干预措施: Educational Materials (Behavioral)
结局指标
主要结局
Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups
时间窗: 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.
次要结局
- 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: 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 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)