At a glance
ClinicalIndex Comparison Record- ✓Confirmed cystic fibrosis diagnosis based on sweat chloride ≥60 mEq/L, two CF clinical features, or two CF-associated genetic mutations
- ✓Pancreatic insufficiency confirmed by fecal elastase ≤100 micrograms per gram of stool or undetectable level
- ✓Age 2.0 to 6.0 years at enrollment
- ✓At least 6 months post CF diagnosis
- ✕Developmental delay (autism, cerebral palsy, or mental retardation)
- ✕Receiving supplemental enteral nutrition via nasogastric tube, gastrostomy, or total parenteral nutrition
- ✕Other growth-affecting disease (insulin-dependent diabetes, congenital heart disease, significant renal disease, bowel resection, short bowel syndrome, colonic strictures)
- ✕Taking medications known to affect growth (insulin, growth hormone, chronic systemic steroids)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Site Randomized Clinical Trial of Behavioral and Nutrition Treatment Designed to Help Preschoolers With Cystic Fibrosis Optimize Growth
In Brief
A clinical study evaluating Behavioral and Nutrition Treatment and Education and Attention Control for Cystic Fibrosis and Pancreatic Cystic Fibrosis. Completed, enrolled 78 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills. The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.
This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.