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Optimizing growth early in life may change the course of clinical lung disease and lead to less morbidity and mortality in this disease. However, toddlers and preschoolers with cystic fibrosis (CF) are not meeting nutritional recommendations. Behavioral factors such as mealtime duration, family mealtime interactions and child mealtime behaviors limit dietary adherence in children with CF. Nutrition interventions that incorporate behavioral therapies have shown promise in increasing energy intake in children with CF.
The objective of this study is to conduct a multicenter, randomized, controlled clinical trial comparing behavioral plus nutrition intervention (BEH) to standard nutritional care with attention control (ATT). The specific aims are to determine the impact of BEH on energy intake and weight gain, examine the durability of BEH’s impact on growth (weight and height) one year following treatment, and identify associations between growth and indicators of lung disease. The centers participating were all accredited CF Centers (Cincinnati Children’s, Nationwide Children’s Hospital in Columbus Rainbow Babies & Children’s Hospital in Cleveland, University of Michigan Health System in Ann Arbor and University of Arizona Respiratory Center in Tucson, as well as CF centers in Dayton and Akron serving as referral sites).
One hundred and two (102) preschoolers with CF and pancreatic insufficiency age 2 to 6 years were randomized to one of the two conditions. Both groups met individually with research staff for seven weekly sessions followed by four monthly sessions. BEH aimed to maximize adherence to a high-energy diet and enzyme replacement therapy, and motivate children to increase their energy intake. Behavioral strategies for setting intake goals as well as child behavior management were incorporated into these BEH sessions. ATT provided developmental anticipatory guidance information to families. While nutrition information was discussed with these families, they did not receive the behavioral aspects of the intervention provided in BEH.
Funded by:National Institutes of Health − National Institute of Diabetes and Digestive and Kidney Diseases, R01 DK54915-06A1.
Study Status: Closed to enrollment
This is a substudy to the larger “Behavioral and Nutrition Treatment to Help Preschoolers with CF Grow” clinical trial. A subset of preschoolers in Cincinnati and Columbus had an HRCT of their lungs conducted at the baseline and 12-month follow-up assessments (18 months in total). The data will allow for a determination of the child’s lung disease status at the initiation of the clinical trial and a determination of the child’s lung disease progression (i.e., change in HRCT scores) over the 18-month period from pretreatment to follow-up. The long-range goal is to follow this cohort of children over time to track the impact of early and effective nutritional treatment on the CF disease process during childhood and adolescence. A rigorous assessment of lung disease status during this clinical trial is necessary for success in meeting this goal.
Funded by:Cystic Fibrosis Foundation
This study focuses on the effectiveness of a treatment booster study designed to assist families in maintaining and / or re-establishing positive changes in energy intake and growth. The booster sessions were designed to address the unique developmental regimen management, behavioral, and nutritional needs for each family. We are obtaining growth and energy intake data at regular intervals through adolescence to better understand the long-term impact on growth of receiving a behavioral and nutrition treatment as toddlers along with booster treatment sessions more than four years later.
Funded by:National Institutes of Health − National Institute of Diabetes and Digestive and Kidney Diseases, K24 DK059973.
Two manuscripts are currently in preparation. The first describes four-year post-treatment energy intake and growth outcomes for a cohort of toddlers with CF whose parents participated in an eight-week behavior-nutrition treatment.
The second manuscript describes general parenting stress and family stress specific to the demands of parenting a child with young child with CF. Health related quality of life questionnaires were used to collect this data in a cohort of toddlers and preschoolers with CF.
Stephanie Filigno and Scott Powers are also collaborating with Lori Stark on translating the face-to-face Be-In-CHARGE! behavior-nutrition treatment into a web-based format. This web intervention will allow families greater access to the nutrition treatment through the use of technology, when traveling to their CF Center is burdensome for them or when their Center does not have a behavioral specialist. The CF Foundation supported development of this project including the development of an iPod touch application for keeping food records and programming for two-way interaction and feedback between the user and coordinators of the web-based intervention.
Filigno SS, Brannon EE, Chamberlin LA, Sullivan SM, Barnett KA, Powers SW. Qualitative analysis of parent experiences with achieving cystic fibrosis nutrition recommendations. Journal of Cystic Fibrosis,11(2); 125-30. Mar, 2012.
Stark LJ, Opipari-Arrigan L, Quittner AL, Bean J, Powers SW. The effects of an intensive behavior and nutrition intervention compared to standard of care on weight outcomes in CF. Pediatric Pulmonology. ; 46(1):31-5. Jan, 2011.
Powers SW. Introduction to the special series on cystic fibrosis: Viewpoints on clinical trials, genetic screening, and behavioral medicine. Children’s Health Care. 37, 1-4. 2008.
Piazza-Waggoner C, Driscoll KA, Gilman DK, Powers SW. A comparison using parent report and direct observation of mealtime behaviors in young children with cystic fibrosis: Implications for practical and empirically-based behavioral assessment in routine clinical care. Children’s Health Care. 37, 38-48. 2008.
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