Weight Gain in CF

This study has been completed.

First Received: August 8, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00006169

Purpose

The current study examines the efficacy of two treatments to help children with cystic fibrosis (CF) meet their dietary calorie requirements of 120% to 150% of the recommended daily allowance of energy and the effect of these treatments on weight gain and maintenance. One treatment provides children with CF and their parents nutrition education about the best foods for meeting their dietary needs. The second treatment gives children with CF and their families similar nutritional information plus behavioral parenting methods for motivating children to eat the recommended foods. Children with CF and their families are seen weekly for 7 treatment sessions across 9 weeks for the active phase of treatment. Families are then followed for 2 years after treatment in order to better understand how long the treatments are effective and to determine the health benefits of better nutrition status and weight gain.

Condition	Intervention	Phase
Cystic Fibrosis	Behavioral: Behavioral Treatment	Phase III

Study Type:	Interventional
Study Design:	Prevention
Official Title:	Behavioral Treatment of Weight Gain in CF

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date:	June 1996
Estimated Study Completion Date:	November 1999

Eligibility

Ages Eligible for Study:	4 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Weight percentile for age or height below 40th for age and sex
Pancreatic insufficiency

Exclusion Criteria:

Developmental delays
Pseudomonas cepacia
Supplemental enteral or parenteral nutrition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006169

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32601
United States, Ohio
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, United States, 45229

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Lori Stark

Children's Hospital Medical Center

More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Stark LJ, Quittner AL, Powers SW, Opipari-Arrigan L, Bean JA, Duggan C, Stallings VA. Randomized clinical trial of behavioral intervention and nutrition education to improve caloric intake and weight in children with cystic fibrosis. Arch Pediatr Adolesc Med. 2009 Oct;163(10):915-21.

Study ID Numbers:	Stark, 50092
Study First Received:	August 8, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006169 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Nutrition
Behavior Therapy
Cystic Fibrosis

Additional relevant MeSH terms:

Fibrosis
Weight Gain
Body Weight
Signs and Symptoms
Digestive System Diseases
Pathologic Processes
Cystic Fibrosis

Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Body Weight Changes
Pancreatic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on November 09, 2009