This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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.
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