title: Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis.
abstract: OBJECTIVE
  To evaluate the efficacy of a behavioral plus nutrition education intervention, Be In CHARGE!, compared with that of a nutrition education intervention alone on caloric intake and weight gain in children with cystic fibrosis and pancreatic insufficiency.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Cystic fibrosis centers in the eastern, midwestern, and southern United States.
  
  
  METHODS
  Seventy-nine children aged 4 to 12 years below the 40th percentile for weight for age were recruited. Sixty-seven completed the intervention and 59 completed a 24-month follow-up assessment.
  
  
  METHODS
  Comparison of a behavioral plus nutrition education intervention with a nutrition education intervention alone.
  
  
  METHODS
  Primary outcomes were changes from pretreatment to posttreatment in caloric intake and weight gain. Secondary outcomes were changes from pretreatment to posttreatment in percentage of the estimated energy requirement and body mass index z score. These outcomes were also examined 24 months posttreatment.
  
  
  RESULTS
  After treatment, the behavioral plus nutrition education intervention as compared with the nutrition education intervention alone had a statistically greater average increase on the primary and secondary outcomes of caloric intake (mean, 872 vs 489 cal/d, respectively), percentage of the estimated energy requirement (mean, 148% vs 127%, respectively), weight gain (mean, 1.47 vs 0.92 kg, respectively), and body mass index z score (0.38 vs 0.18, respectively). At the 24-month follow-up, children in both conditions maintained an estimated energy requirement of around 120% and did not significantly differ on any outcomes.
  
  
  CONCLUSIONS
  A behavioral plus nutrition education intervention was more effective than a nutrition education intervention alone at increasing dietary intake and weight over a 9-week period. However, across the 24-month follow-up, both treatments achieved similar outcomes. Trial Registration clinicaltrials.gov Identifier: NCT00006169.
authors.affiliation: Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio 45229, USA. lori.stark@cchmc.org
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Stark
authors.forename: Alexandra L
authors.initials: AL
authors.lastname: Quittner
authors.forename: Scott W
authors.initials: SW
authors.lastname: Powers
authors.forename: Lisa
authors.initials: L
authors.lastname: Opipari-Arrigan
authors.forename: Judy A
authors.initials: JA
authors.lastname: Bean
authors.forename: Christopher
authors.initials: C
authors.lastname: Duggan
authors.forename: Virginia A
authors.initials: VA
authors.lastname: Stallings
mesh_terms: D001521:Behavior Therapy; D002648:Child; D002675:Child, Preschool; D003550:Cystic Fibrosis / Q000628:therapy*; D002149:Energy Intake; D005247:Feeding Behavior; D005260:Female; D005500:Follow-Up Studies; D006266:Health Education; D006801:Humans; D008297:Male; D016487:Parenting; D013851:Thinness / Q000628:therapy*; D014481:United States; D015430:Weight Gain