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Published on: August 21, 2015
Behavioral and nutritional treatment for preschool-aged children with cystic fibrosis: a randomized clinical trial
Scott W Powers1, Lori J Stark1, Leigh A Chamberlin2
1Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio2Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.
Insights
Behavioral and nutritional intervention significantly improved energy intake and height in children with cystic fibrosis (CF). This approach shows promise for improving growth in young CF patients.
Area of Science:
- Pediatric Gastroenterology
- Nutritional Science
- Clinical Trial Research
Background:
- Optimal energy intake and growth are critical for preschool-aged children with cystic fibrosis (CF).
- Evidence-based treatments are needed to address nutritional challenges in young CF patients.
Purpose of the Study:
- To evaluate the efficacy of a behavioral and nutritional intervention compared to an education control in improving energy intake and growth metrics in preschool-aged children with CF.
- To assess the impact of the intervention on weight z-score (WAZ) and height z-score (HAZ).
Main Methods:
- A randomized clinical trial involving 78 children aged 2-6 years with CF and pancreatic insufficiency.
- Intervention group received individualized nutritional counseling and behavioral child management skills training.
- Control group received education as a behavioral placebo; both delivered in-person or via telehealth over 6 months.
Main Results:
- The intervention group showed a significantly greater increase in daily energy intake (485 kcal vs 58 kcal) compared to the control group (P < .001).
- A significant improvement in height z-score (HAZ) was observed in the intervention group at 18-month follow-up (adjusted difference, 0.14 units; P = .049).
- No significant difference was found in weight z-score (WAZ) between the groups at 6 months.
Conclusions:
- Behavioral and nutritional intervention effectively improved energy intake and height z-scores in preschool-aged children with CF.
- The findings suggest that this intervention is a potentially efficacious nutritional strategy for young children with CF and pancreatic insufficiency.
- Further research may explore long-term impacts and WAZ score improvements.
Importance:
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.
Design, Setting, And Participants:
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.
Interventions:
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.
Main Outcomes And Measures:
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 And Relevance:
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.
Trial Registration:
clinicaltrials.gov Identifier:NCT00241969.
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