Web-based Physical Activity Intervention for Children with ALL

针对 ALL 儿童的基于网络的身体活动干预

• 批准号: 9298607
• 负责人: Kirsten Kimberlie Ness
• 金额: $ 86.99万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9298607
• 关键词: Accelerometer; Acute Disease; Acute Lymphocytic Leukemia; Adolescent; Adopted; Aftercare; Biological Markers; Body mass index; Bone Density; Cardiomyopathies; Child; Childhood Acute Lymphocytic Leukemia; Childhood Leukemia; Complement; Computer software; Computers; Control Groups; Data; Diagnosis; Educational Materials; Effectiveness; Enrollment; Evaluation; Fasting; Fatigue; Future; Gifts; Glucose; Goals; Health; Height; Individual; Inflammation; Inflammatory; Insulin; Intervention; Late Effects; Lipids; Literature; Measures; Mediating; Modeling; Modification; Neuropathy; Online Systems; Only Child; Participant; Pediatric Oncology Group; Peripheral Nervous System Diseases; Physical activity; Physiological; Pilot Projects; Population; Protocols documentation; Quality of life; Randomized; Recruitment Activity; Reporting; Research; Research Infrastructure; Resources; Rewards; Sampling; Schools; Site; Survival Rate; Survivors; System; Testing; Therapeutic; Time; Video Games; Walking; Wireless Technology; adipokines; arm; base; blood pressure reduction; chemotherapy; cost; cost effective; dashboard; design; efficacy testing; experience; fitness; group intervention; handheld mobile device; improved; intervention effect; learning materials; neuromusculoskeletal; obesity risk; portability; prevent; prospective; psychosocial; public health relevance; sedentary; sedentary lifestyle; survivorship; therapy design; tool; treatment effect; web site

The five year survival rate among children diagnosed with acute lymphoblastic leukemia (ALL) has surpassed 90%. Unfortunately, cure is not without consequences. ALL survivors are at elevated risk for obesity, low bone mineral density, cardiomyopathy, peripheral neuropathy, and altered psychosocial functioning. Research is critically needed to provide survivors with tools to improve their long term health. Because children with leukemia are likely to adopt a sedentary lifestyle that persists long into survivorship, and because a sedentary lifestyle may perpetuate or exacerbate many of the complications experienced by ALL survivors, a portable and generalizable intervention that promotes physical activity and impacts fitness and biomarkers of cardiometabolic health in the first year after treatment may be of particular benefit. This proposal is designed to access the resources of the Children's Oncology Group (COG) and complements ongoing therapeutic protocols. It will draw upon the existing infrastructure and expertise of the COG to recruit a sample of children as they complete treatment for childhood ALL. The primary goals of this study are to evaluate the effects of a rewards-based physical activity intervention, delivered via an interactive website for children with ALL, during a six month period beginning any time during the first three months after the end of curative chemotherapy, on fitness, biomarkers of cardiometabolic health, inflammation, adipokine status, quality of life and school attendance. We also plan to evaluate if the effects of the intervention on markers of cardiometabolic health are mediated by changes in fitness. To achieve this goal we have designed a two-arm, prospective, randomized study with a rewards- based intervention group (N=192) and a control group (N=192). The control group will receive educational materials encouraging physical activity, including information about activity modifications for common neuromusculoskeletal deficits (e.g. neuropathy, weakness), and an activity monitor to record physical activity levels. The intervention group will receive the same educational materials, the activity monitor, and access to a rewards-based interactive website designed to motivate increased levels of physical activity. Intervention group participants will receive points based on physical activity levels. Points are redeemed for small gift cards ($5.00) during the course of the study. Based on our pilot study, the average child/adolescent will earn eight gift cards. Individual physical activity levels are uploaded to the website (with acknowledgement of the data upload for control group participants, and with an interactive video game-type dashboard for intervention group participants when the activity monitor is connected to a computer). Rewards and encouragement are provided by the website based on the intervention participants' measured physical activity levels. Children who are initially less active still earn points as the rewards system is based on individual baseline physical activity. Evaluation time points are planned at baseline, after intervention, and six months and one year after the intervention is completed.

儿童急性淋巴细胞白血病（ALL）的五年生存率已超过 百分之九十不幸的是，治愈并非没有后果。所有的幸存者都有肥胖、低骨密度 矿物质密度、心肌病、周围神经病变和社会心理功能改变。研究是 迫切需要为幸存者提供改善其长期健康的工具。因为患有白血病的儿童 很可能会采取久坐不动的生活方式，这种生活方式会持续很长时间， 可能使ALL幸存者经历的许多并发症永久化或加剧， 促进身体活动并影响健康和心脏代谢生物标志物的普遍干预 治疗后第一年的健康可能特别有益。本提案旨在访问 儿童肿瘤学小组（COG）的资源，并补充正在进行的治疗方案。委员会将提请 在现有的基础设施和专业知识的COG招募儿童样本，因为他们完成 儿童ALL的治疗。本研究的主要目的是评估基于奖励的 在六个月期间，通过互动网站为ALL儿童提供身体活动干预 在治愈性化疗结束后的前三个月内的任何时间开始， 心脏代谢健康、炎症、脂肪因子状态、生活质量和入学率。我们也 计划评估干预措施对心脏代谢健康标志物的影响是否由变化介导 健身。为了实现这一目标，我们设计了一项两组、前瞻性、随机研究， 干预组（N=192）和对照组（N=192）。对照组将接受教育 鼓励体育活动的材料，包括有关活动修改的信息， 神经肌肉骨骼缺陷（例如神经病变、虚弱），以及记录身体活动的活动监测器 程度.干预组将收到相同的教育材料，活动监测器，并获得一个 基于奖励的互动网站，旨在激励增加身体活动水平。干预组 参加者可根据体力活动的程度获得积分。积分可兑换小礼品卡（5美元） 在研究过程中。根据我们的试点研究，儿童/青少年平均将获得8份礼物， 卡.将个人体力活动水平上传至网站（并确认数据上传 对于对照组参与者，以及对于干预组参与者， 当活动监视器连接到计算机时，参与者）。提供奖励和鼓励 根据干预参与者测量的身体活动水平，儿童最初 不太活跃的人仍然可以获得积分，因为奖励系统是基于个人的基线体力活动。评价 在基线、干预后、干预后6个月和1年时计划时间点， 完成