Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis.
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.
Stark
Lori J
LJ
Department of Pediatrics, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio 45229, USA. lori.stark@cchmc.org
Quittner
Alexandra L
AL
Powers
Scott W
SW
Opipari-Arrigan
Lisa
L
Bean
Judy A
JA
Duggan
Christopher
C
Stallings
Virginia A
VA
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