NCT00006169

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1996

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2000

Completed
Last Updated

March 2, 2010

Status Verified

March 1, 2010

First QC Date

August 8, 2000

Last Update Submit

March 1, 2010

Conditions

Cystic Fibrosis

Keywords

NutritionBehavior TherapyCystic Fibrosis

Interventions

Behavioral TreatmentBEHAVIORAL

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Developmental delays
  • Pseudomonas cepacia
  • Supplemental enteral or parenteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Florida

Gainesville, Florida, 32601, United States

Location

Children's Hospital Medical Center, Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • 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. doi: 10.1001/archpediatrics.2009.165.

    PMID: 19805710DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lori Stark

    Children's Hospital & Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

August 8, 2000

First Posted

August 9, 2000

Study Start

June 1, 1996

Study Completion

November 1, 1999

Last Updated

March 2, 2010

Record last verified: 2010-03

Locations

US(2)