NOURISH-T+: A Randomized Control Trial Targeting Parents in Promoting Healthy Eating and Exercise Behaviors in Pediatric Cancer Survivors with Overweight/Obesity

项目摘要 对解决儿童癌症幸存者超重/肥胖的干预需求尚未得到满足 (Pc)治疗后。未接受治疗的儿童癌症幸存者(PCS)的超重和肥胖率为 高于普通儿科人群，从40%到50%不等，显著增加了他们患上 随之而来的负面健康后果。当幸存者成年时，他们的比例是10.8倍 与健康的兄弟姐妹相比，他们更有可能患有心血管疾病。在PCS世卫组织中降低成人肥胖风险 通过促进健康的饮食和体力活动(PA)行为来超重或肥胖 对这些幸存者具有重要的预防作用。我们最近评估了我们干预的可行性， 为健康的过渡滋养(Nutiish-T)，通过以父母为促进剂为肥胖的PCS 变化。结果表明，Nutiish-T不仅可行，而且显示出良好的疗效。我们 进一步改进了我们的干预措施，现在称为Nutiish-T+，并在这个更大的多站点实施这些措施 RCT，目的是评估我们在不同的儿科肿瘤诊所进行干预的效果。 我们的重点是让家长示范健康饮食和PA行为，以促进PCS行为的改变。主题 与PCS的父母有关(例如，向存活的过渡和迟发效应)。PCS的父母 对于超重/肥胖(BMI和GT；85%ILE)，5-11岁，停止治疗1-5年将被随机分配到 营养-T+干预或加强日常护理(EUC)的比较。营养-T+中的父母参与 一次为期6次的人工干预，包括一次额外的营养师会议和两次PCS会议，以及 干预助推会。会议通过视频会议平台进行。EUC由一个 一次性信息交流会、全国可用的小册子和后续登记。 父母和PCS在基线、3-、6-、 干预后12个月。我们将从Johns招收一个由260名父母/PCS二人组成的高度多样化的小组 霍普金斯医疗中心(JH)，尼克劳斯儿童医院，迈阿密儿童保健系统(MC)，约翰斯 霍普金斯/所有儿童医院(ACH)和弗吉尼亚联邦大学(VCU)。南方大学 佛罗里达州(USF)是干预、数据管理和分析的协调中心。 ·目标1a：评估Nutiish-T+对儿童BMI z评分的主要结果的影响。 ·目标1b：评估Nutiish-T+对次要结果的影响：PCS腰臀比(WHR)、PA和 进食行为。 ·目标2：评估营养素-T+对父母的影响，包括BMI、腰臀比、PA和饮食 行为，以及对儿童-家庭饮食和PA实践的看法。 ·探索性目标：评估干预的潜在主持人，并检查二元 父母与子女之间的关系。

Project Summary There is an unmet need for interventions that address overweight/obesity in pediatric cancer survivors (PCS) after treatment. Rates of overweight and obesity for off-treatment pediatric cancer survivors (PCS) are higher than in the general pediatric population, ranging from 40% to 50%, significantly increasing their risk for concomitant negative health consequences. By the time survivors reach young adulthood they are 10.8 times more likely to have cardiovascular disease than healthy siblings. Reducing the risk of adult obesity in PCS who are overweight or obese by promoting healthy dietary and physical activity (PA) behaviors may serve an important preventive function for these survivors. We recently evaluated the feasibility of our intervention, NOURISH for Healthy Transitions (NOURISH-T), for PCS with obesity by targeting parents as agents for change. Results demonstrated that NOURISH-T was not only feasible, but showed promise of efficacy. We further refined our intervention, now referred to as NOURISH-T+, and implement these in this larger, multi-site RCT, with the aim of evaluating the efficacy of our intervention across diverse pediatric oncology clinics. We focus on parents to model healthy eating and PA behaviors to promote PCS behavior change. Topics relevant to parents of PCS (e.g., transitioning to survivorship and late effects) are discussed. Parents of PCS with overweight/obesity (BMI > 85th%ile), age 5-11, 1- <5 years off treatment will be randomly assigned to the NOURISH-T+ intervention or Enhanced Usual Care (EUC) comparison. Parents in NOURISH-T+ participate in a 6-session, manualized intervention, with an additional dietician session and 2 PCS sessions, as well as post- intervention booster sessions. Sessions are conducted via a videoconferencing platform. EUC consists of a one-time informational session, nationally available brochures and follow-up check-ins. Parents and PCS are assessed on anthropometric measures, PA and dietary behaviors at baseline, 3-, 6-, and 12-months post-intervention. We will enroll a highly diverse group of 260 parents/PCS dyads from Johns Hopkins Medical Center (JH), Nicklaus Children’s Hospital, Miami Children’s Health Care System (MC), Johns Hopkins/All Children’s Hospital (ACH), and Virginia Commonwealth University (VCU). University of South Florida (USF) serves as the coordinating center for intervention, data management and analyses. • Aim 1a: Evaluate NOURISH-T+ for its impact on the primary outcome of child BMI z-score. • Aim 1b: Evaluate NOURISH-T+ on secondary outcomes: PCS waist-to-hip-ratio (WHR), PA and eating behaviors. • Aim 2: Evaluate the impact of NOURISH-T+ on parents, including BMI, WHR, PA and eating behaviors, and perceptions of child-family eating and PA practices. • Exploratory Aim: Evaluate potential moderators of the intervention and examine the dyadic relations between parents and children.