BEHAVIORAL AND NUTRITION TREATMENT IN CF

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项由NIH资助的临床试验的主要目的是进行一项多中心、随机、对照试验，比较两种干预措施：行为加营养干预和营养（注意力控制）干预。 所有受试者将接受符合2002年CF共识会议儿科营养指南的营养护理。 具体目标是： 1.确定行为干预对能量摄入的影响， 体重增加; 2.检查行为干预对增长影响的持久性 （体重和身高）治疗后1年;以及 3.探索身体活动与生长之间的关系。 来自俄亥俄州（辛辛那提、哥伦布、克利夫兰）的三个经认证的CF中心的100名2 - 6岁CF和胰腺功能不全的学龄前儿童将被随机分配至两种情况之一。 行为加营养干预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。注意力控制条件控制接触时间和进行的评估次数。 这两种干预措施都包括每周7次，然后每月4次。 将在基线、治疗后（6个月）和12个月随访（基线后18个月）时获得结局数据（通过7天饮食记录测量的能量摄入、体重、身高）。 次要指标将包括体重指数、DXA和皮褶测量的身体成分以及生长速度。 这项研究推进了CF幼儿早期营养干预的调查，并直接解决了需要控制，纵向评估行为干预对生长的影响。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition (attention control) intervention. All subjects will receive nutritional care consistent with the 2002 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. 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 behavior plus nutrition intervention will maximize adherence to a high energy diet and enzyme replacement therapy, and motivate children to increase their energy intake. The attention control condition controls for time of contact and number of assessments conducted. Both interventions involve 7 weekly sessions followed by 4 monthly sessions. 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. 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.