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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 . DESIGN Randomized controlled trial . SETTING Cystic fibrosis centers in the eastern , midwestern , and southern United States . PARTICIPANTS 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 . INTERVENTION Comparison of a behavioral plus nutrition education intervention with a nutrition education intervention alone . MAIN OUTCOME MEASURES 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 .
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Intervention_Educational
behavioral plus nutrition education intervention
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Intervention_Educational
nutrition education intervention alone
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Outcome_Physical
caloric intake
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Outcome_Physical
weight gain
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Outcome_Physical
caloric intake
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Outcome_Physical
weight gain
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Outcome_Physical
percentage of the estimated energy requirement
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Outcome_Physical
body mass index z score
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Outcome_Physical
caloric intake
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Outcome_Physical
percentage of the estimated energy requirement
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Outcome_Physical
weight gain
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Outcome_Physical
body mass index z score
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Outcome_Physical
energy requirement
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Participant_Condition
cystic fibrosis
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Participant_Condition
cystic fibrosis
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Participant_Condition
pancreatic insufficiency
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Participant_Sample-size
Seventy-nine
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Participant_Age
aged 4 to 12 years
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Participant_Condition
below the 40th percentile for weight for age