Behavioral Treatment of Weight Gain in CF | NCT00006169

Studies
Behavioral Treatment of Weight Gain in CF

NCT00006169

Sponsor

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

Status

Completed

Last Update Posted

Mar 2, 2010Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Cystic Fibrosis

Interventions

Behavioral Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
50092

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1996

Primary Completion Date

Not provided

Completion Date

Nov 1999

First Submitted Date

Aug 8, 2000

First Submission Date that Met QC Criteria

Aug 8, 2000

First Posted Date

Aug 9, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2010

Last Update Posted Date

Mar 2, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

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

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Behavioral Treatment	Behavioral

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lori Stark	Children's Hospital & Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32601	United States
Children's Hospital Medical Center, Cincinnati

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19805710	Derived	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.

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities