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NCT00006169 Clinical Trial

Behavioral Treatment of Weight Gain in CF

Cystic Fibrosis Clinical Trial

Official title:
Behavioral Treatment of Weight Gain in CF

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006169
Other study ID # Stark (completed)
Secondary ID 50092
Status Completed
Phase Phase 3
First received August 8, 2000
Last updated March 1, 2010
Start date June 1996
Est. completion date November 1999

Study information
Verified date March 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date November 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 12 Years
Eligibility 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

Study Design

Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Behavioral Treatment

Locations
Country Name City State
United States Children's Hospital Medical Center, Cincinnati Cincinnati Ohio
United States University of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

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