Behavioral & Nutrition Tx to Help CF Preschoolers Grow

尽管迫切需要，但在囊性纤维化(CF)幼儿中实现和维持最佳生长的循证营养干预措施并不存在。这样的干预可以积极改变临床肺部疾病的进程，提高这些儿童的存活率。这项竞争性持续研究的目的是进行一项多中心、随机、对照的临床试验，比较行为加营养干预。 将注意力控制干预条件改为注意控制干预条件。所有受试者都将接受符合2001年儿童营养共识会议儿科营养指南的营养护理。具体目的是：1.确定行为干预对能量摄入和体重增加的影响；2.检查行为干预对治疗后一年的生长(体重和身高)影响的持久性；3.探索体力活动与生长之间的关系。中心假设是，行为干预将导致更好的生长，通过体重和身高随年龄z分数的变化来衡量。来自三个经认可的CF中心 俄亥俄州(辛辛那提、哥伦布、克利夫兰)，100名患有CF和胰腺功能不全的2至6岁学龄前儿童将随机分为两种情况之一。两组将进行分层，以便他们在开始治疗时年龄体重z评分相似。其他关键变量，如铜绿假单胞菌感染史和性别，将在统计分析计划中用作协变量。结果数据(通过7天饮食记录、体重、身高测量的能量摄入量)将在基线、治疗后(6个月)和 经过12个月的随访(基线后18个月)。次要指标将包括体重指数、用DXA和皮褶测量的身体成分以及生长速度。行为疗法将最大限度地坚持高能量饮食和酶替代疗法，并激励儿童增加能量摄入。它包括每周7次会议，然后是每月4次会议。注意状况控制着联系的时间和进行的评估次数。这项研究推进了对患有CF的幼儿的早期营养干预的研究，并直接解决了对生长发育的行为干预进行可控的、纵向的评估的必要性。长期目标是改变患有CF的幼儿的营养护理标准，因为行为干预会导致最佳生长，并最终改善肺部健康和生存。

Evidence-based nutritional interventions that achieve and sustain optimal growth in young children with cystic fibrosis (CF) do not exist, despite an urgent need. Such an intervention could positively change the course of clinical lung disease and enhance survival for these children. The objective of this competing continuation study is to conduct a multi-center, randomized, controlled clinical trial comparing a behavioral plus nutrition intervention condition to an attention control intervention condition. All subjects will receive nutritional care consistent with the 2001 CF Consensus Conference guidelines for pediatric nutrition. The specific aims are to: 1. determine the impact of the behavioral intervention on energy intake and weight gain; 2. examine the durability of the behavioral intervention's impact on growth (weight and height) one year following treatment', and 3. explore the relation between physical activity and growth. The central hypothesis is that behavioral intervention will lead to better growth as measured by change in weight and height for age z scores. From three accredited CF Centers in Ohio (Cincinnati, Columbus, Cleveland), 100 preschoolers with CF and pancreatic insufficiency age 2 to 6 years will be randomized to one of the two conditions. The two groups will be stratified so that they are similar at the initiation of treatment on weight for age z score. Other critical variables such as history of Pseudomonas aeruginosa infection and gender will be used as covariates in the statistical analysis plan. Outcome data (energy intake measured by 7-day diet record, weight, height) will be obtained at baseline, post-treatment (6 months), and after a 12-month follow-up (18 months post baseline). Secondary measures will include body mass index, body composition measured by DXA and skinfolds, and growth velocity. Behavioral treatment will maximize adherence to a high energy diet and enzyme replacement therapy, and motivate children to increase their energy intake. It involves 7 weekly sessions followed by 4 monthly sessions. The attention condition controls for time of contact and number of assessments conducted. This study advances the investigation of early nutritional interventions for young children with CF and directly addresses the need for controlled, longitudinal assessment of behavioral intervention on growth. The long-range goal is to change the standard of nutritional care for young children with CF because behavioral intervention leads to optimal growth and ultimately improves lung health and survival.