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

NOURISH-T：一项针对父母促进超重/肥胖儿童癌症幸存者健康饮食和运动行为的随机对照试验

• 批准号: 10738021
• 负责人: Marilyn Stern
• 金额: $ 13.5万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-12-01 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10738021
• 关键词: Accelerometer; Address; Adherence; Aftercare; Age; Behavior; Behavioral; Blinded; Body Weight decreased; Body mass index; Cardiovascular Diseases; Characteristics; Child; Child health care; Childhood; Childhood Cancer Treatment; Chronic Disease; Clinic; Collaborations; Data; Data Analyses; Diabetes Mellitus; Dietary Assessment; Eating; Eating Behavior; Effectiveness of Interventions; Energy Intake; Enrollment; Exercise; Family; Fatty acid glycerol esters; Florida; Frequencies; Future; Goals; Health; Health behavior change; Healthcare Systems; Healthy Eating; Height; Hour; Intake; Intervention; Late Effects; Maintenance; Manuals; Measures; Medical center; Metabolic syndrome; Modeling; Obesity; Obesity Epidemic; Outcome; Overweight; Pamphlets; Parents; Participant; Patient Recruitments; Patient Self-Report; Pediatric Hospitals; Pediatric Oncology; Perception; Physical activity; Population; Preventive; Public Health; Randomized; Randomized, Controlled Trials; Recording of previous events; Reporting; Research; Research Personnel; Risk; Risk Reduction; Sampling; Siblings; Site; Survivors; Testing; Time; Translations; Universities; Videoconferencing; Virginia; Vulnerable Populations; Waist-Hip Ratio; Weight; Weight Gain; Work; acceptability and feasibility; adult obesity; base; behavior change; cancer therapy; childhood cancer survivor; clinical practice; data management; dietary; effectiveness evaluation; efficacy evaluation; efficacy testing; ethnic diversity; follow-up; healthy weight; high risk population; improved; intervention delivery; modifiable behavior; obesity in children; obesity risk; obesity treatment; physical conditioning; pilot trial; post intervention; primary outcome; racial diversity; recruit; role model; secondary outcome; sedentary activity; sugar; survivorship; treatment as usual; young adult

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.

项目摘要 儿童癌症幸存者超重/肥胖的干预需求尚未得到满足 (PCS)治疗后停止治疗的儿童癌症幸存者（PCS）的超重和肥胖率为 高于一般儿科人群，范围从40%到50%，显著增加了他们的风险， 伴随的负面健康后果。当幸存者到达成年时， 比健康的兄弟姐妹更容易患心血管疾病。降低PCS中成人肥胖的风险， 通过促进健康的饮食和体育活动（PA）行为，超重或肥胖可能有助于 对这些幸存者来说是重要的预防功能。我们最近评估了干预的可行性， NOURISH for Healthy Transitions（NOURISH-T），通过将父母作为 变化结果表明，NOURISH-T不仅是可行的，而且显示出有效性。我们 进一步完善了我们的干预措施，现在称为NOURISH-T+，并在这个更大的多站点实施这些措施。 RCT，旨在评估我们在不同儿科肿瘤诊所的干预效果。 我们专注于父母的健康饮食和PA行为，以促进PCS行为的改变。主题 与PCS的父母相关（例如，过渡到生存和后期影响）进行了讨论。父母PCS 超重/肥胖（BMI > 85th%ile），年龄5-11岁，停止治疗1- <5年，将被随机分配到 NOURISH-T+干预或增强型糖尿病护理（EUC）比较。NOURISH-T+的家长参与 一个6个疗程的手动干预，包括一个额外的营养师疗程和2个PCS疗程，以及术后 干预加强会议。会议通过视频会议平台进行。EUC由一个 一次性情况介绍会、在全国提供的小册子和后续登记。 父母和PCS在基线、3-、6-、10 和干预后12个月。我们将招募一个高度多样化的260名来自约翰的父母/PCS二元组 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 霍普金斯/所有儿童医院（ACH）和弗吉尼亚联邦大学（VCU）。University of South 佛罗里达（USF）作为干预、数据管理和分析的协调中心。 目标1a：评估NOURISH-T+对儿童BMI z评分主要结局的影响。 ·目标1b：评估NOURISH-T+对次要结局的影响：PCS腰臀比（WHR）、PA和 饮食行为。 目标2：评估NOURISH-T+对父母的影响，包括BMI、WHR、PA和饮食 行为，以及儿童家庭饮食和PA做法的看法。 ·探索性目标：评估干预的潜在调节因素，并检查二元 父母与子女的关系。