N/A
N=78
Behavioral & Nutritional Treatment to Help CF Preschoolers Grow
Cystic Fibrosis · Pancreatic Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00241969 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change in Energy Intake From Baseline to Post Treatment — 485; 58 kilocalories per day — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral and Nutrition Treatment (Behavioral); Education and Attention Control (Behavioral)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Energy Intake From Baseline to Post Treatment |
485; 58 | <0.001 sig |
| PRIMARY Change in Weight for Age Z-Score (WAZ) From Baseline to Post Treatment |
0.12; 0.06 | 0.25 |
| PRIMARY Change in Height for Age Z-Score (HAZ) From Baseline to Follow Up |
0.09; -0.02 | 0.049 sig |
Summary
The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition intervention. This study will (a) determine the impact of the behavioral intervention on energy intake and weight gain; (b) examine the durability of the behavioral intervention's impact on growth (weight and height) one year following treatment; and (c) explore the relation between physical activity and growth.
Eligibility Criteria
Inclusion Criteria
- confirmed diagnosis of cystic fibrosis based upon 2 of the following: a. sweat chloride by quantitative pilocarpine electrophoresis ≥60 milliequivalent/Liter (mEq/L), b. two clinical features consistent with CF, or c. genetic testing demonstrating two mutations associated with CF
- confirmation of pancreatic insufficiency based upon fecal elastase of ≤ 100 micrograms per gram of stool (or an undetectable level)
- age at enrollment to the trial of 2.0 years to 6.0 years
- at least 6 months post CF diagnosis
- consuming an unrestricted fat diet
Exclusion Criteria
- diagnosis of developmental delay (i.e., autism, cerebral palsy, or mental retardation)
- receiving supplemental enteral nutrition via nasogastric tube, gastrostomy, or total parenteral nutrition
- diagnosed with another disease/condition (e.g., insulin dependent diabetes, congenital heart disease, significant renal disease, history of bowel resection or short bowel syndrome, colonic strictures) known to affect growth
- taking a medication (e.g., insulin, growth hormone, chronic use of systemic steroids) known to affect growth
- screening assessment shows genetic potential for height as acceptable according to the 2001 Consensus Conference guidelines and diet diary indicates daily Dietary Reference Intake (DRI) of energy average of 140% or greater (DRI of 100% will be determined as the estimated energy requirement [EER] based upon the child's age, gender, and an active physical activity level
- weight z score (age and gender adjusted) of > 1.0
- prior participation in the pilot intervention studies conducted by the PI during the prior period of R01 funding or current participation in an intervention trial conducted by the Cystic Fibrosis Therapeutics Development Network.
Data sourced from ClinicalTrials.gov (NCT00241969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.