Behavioral and nutritional treatment for preschool-aged children with cystic fibrosis: a randomized clinical trial.
OBJECTIVE
Evidence-based treatments that achieve optimal energy intake and improve growth in preschool-aged children with cystic fibrosis (CF) are a critical need.


OBJECTIVE
To test whether behavioral and nutritional treatment (intervention) was superior to an education and attention control treatment in increasing energy intake, weight z (WAZ) score, and height z (HAZ) score.


METHODS
This randomized clinical trial included 78 children aged 2 to 6 years (mean age, 3.8 years) with CF and pancreatic insufficiency (intervention, n = 36 and control, n = 42). The study was conducted at 7 CF centers between January 2006 and November 2012; all 78 participants who met intent-to-treat criteria completed through follow-up.


METHODS
Behavioral intervention combined individualized nutritional counseling targeting increased energy intake and training in behavioral child management skills. The control arm provided education and served as a behavioral placebo controlling for attention and contact frequency. Both treatments were delivered in person or telehealth (via telephone). Sessions occurred weekly for 8 weeks then monthly for 4 months (6 months). Participants then returned to standard care for 1 year, with 12-month follow-up thereafter.


METHODS
Changes in energy intake and WAZ score were examined from pretreatment to posttreatment (6 months) and change in HAZ score was assessed pretreatment to follow-up (18 months). Covariates included sex, Pseudomonas aeruginosa status at baseline, and treatment modality (in person vs telehealth).


RESULTS
At baseline, mean (SD) energy intake was 1462 (329) kcals/d, WAZ score was -0.44 (0.81), and HAZ score was -0.55 (0.84). From pretreatment to posttreatment, the intervention increased daily energy intake by 485 calories vs 58 calories for the control group (adjusted difference, 431 calories; 95% CI, 282 to 581; P < .001) and increased the WAZ score by 0.12 units vs 0.06 for the control (adjusted difference, 0.09; 95% CI, -0.06 to 0.24; P = .25). From pretreatment to follow-up, the intervention increased the HAZ score by 0.09 units vs -0.02 for the control (adjusted difference, 0.14 units; 95% CI, 0.001 to 0.27; P = .049). Measured treatment integrity and credibility were high for both groups.


CONCLUSIONS
Behavioral and nutritional intervention improved energy intake and HAZ score outcomes but not WAZ score outcomes. Our results provide evidence that behavioral and nutritional treatment may be efficacious as a nutritional intervention for preschoolers aged 2 to 6 years with CF and pancreatic insufficiency.


BACKGROUND
clinicaltrials.gov Identifier:NCT00241969.
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio2Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Scott W
SW
Powers
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio2Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Lori J
LJ
Stark
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Leigh A
LA
Chamberlin
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio2Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Stephanie S
SS
Filigno
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Stephanie M
SM
Sullivan
The Ohio State University College of Medicine, Columbus4Nationwide Children's Hospital, Columbus, Ohio.
Kathleen L
KL
Lemanek
University of Michigan Medical School, Ann Arbor6C. S. Mott Children's Hospital, Ann Arbor, Michigan.
Jennifer L
JL
Butcher
Florida State University College of Medicine, Tallahassee.
Kimberly A
KA
Driscoll
Department of Pediatrics, University of Arizona, Tucson.
Cori L
CL
Daines
Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio9Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Alan S
AS
Brody
Case Western Reserve University School of Medicine, Cleveland, Ohio11Rainbow Babies and Children's Hospitals, Cleveland, Ohio.
Teresa
T
Schindler
Case Western Reserve University School of Medicine, Cleveland, Ohio11Rainbow Babies and Children's Hospitals, Cleveland, Ohio.
Michael W
MW
Konstan
The Ohio State University College of Medicine, Columbus4Nationwide Children's Hospital, Columbus, Ohio.
Karen S
KS
McCoy
University of Michigan Medical School, Ann Arbor.
Samya Z
SZ
Nasr
The Ohio State University College of Medicine, Columbus4Nationwide Children's Hospital, Columbus, Ohio.
Robert G
RG
Castile
Department of Child Health, University of Missouri Women and Children's Hospital, Columbia.
James D
JD
Acton
Department of Pediatrics, St Louis University School of Medicine, St Louis, Missouri.
Jamie L
JL
Wooldridge
Case Western Reserve University School of Medicine, Cleveland, Ohio11Rainbow Babies and Children's Hospitals, Cleveland, Ohio.
Roberta A
RA
Ksenich
Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio15Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Rhonda D
RD
Szczesniak
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio2Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Joseph R
JR
Rausch
Perelman School of Medicine, University of Pennsylvania, Philadelphia17Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Virginia A
VA
Stallings
Perelman School of Medicine, University of Pennsylvania, Philadelphia17Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Babette S
BS
Zemel
Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio15Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
John P
JP
Clancy
D002648:Child; D002675:Child, Preschool; D015928:Cognitive Behavioral Therapy; D003550:Cystic Fibrosis / Q000503:physiopathology / Q000628:therapy*; D002149:Energy Intake; D006801:Humans; D044623:Nutrition Therapy; D017063:Outcome Assessment, Health Care