Behavioral & Nutritional Treatment to Help CF Preschoolers Grow

Completed · Not applicable

Conditions studied: Cystic Fibrosis, Pancreatic Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00241969

Run by

Children's Hospital Medical Center, Cincinnati

People needed

78

Starts

2006-01-01

Expected to finish

2015-06-01

Last updated by the study team

2018-05-22

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Rainbows and Babies Children's Hospital — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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