Behavioral Treatment of Weight Gain in CF

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00006169
First received: August 8, 2000
Last updated: March 1, 2010
Last verified: March 2010
  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 3

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00006169     History of Changes
Other Study ID Numbers: Stark (completed), 50092
Study First Received: August 8, 2000
Last Updated: March 1, 2010
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:
Cystic Fibrosis
Fibrosis
Weight Gain
Body Weight
Body Weight Changes
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014