Back to resultsBehavioral Treatment of Weight Gain in CF
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Behavioral Treatment
Sponsored by
About this trial
This is an interventional prevention trial for Cystic Fibrosis focused on measuring Nutrition, Behavior Therapy, Cystic Fibrosis
Eligibility 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
Sites / Locations
- University of Florida
- Children's Hospital Medical Center, Cincinnati
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006169
First Posted
August 8, 2000
Last Updated
March 1, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00006169
Brief Title
Behavioral Treatment of Weight Gain in CF
Official Title
Behavioral Treatment of Weight Gain in CF
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Nutrition, Behavior Therapy, Cystic Fibrosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Stark
Organizational Affiliation
Children's Hospital & Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32601
Country
United States
Facility Name
Children's Hospital Medical Center, Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19805710
Citation
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.
Results Reference
derived
Learn more about this trial
Behavioral Treatment of Weight Gain in CF
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