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Behavioral & Nutritional Treatment to Help CF Preschoolers Grow

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ClinicalTrials.gov Identifier: NCT00241969
Recruitment Status : Completed
First Posted : October 19, 2005
Results First Posted : April 17, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Cystic Fibrosis
Pancreatic Cystic Fibrosis
Interventions: Behavioral: Behavioral and Nutrition Treatment
Behavioral: Education and Attention Control

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Behavioral and Nutrition Treatment

Behavioral and Nutrition Treatment

Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills.

Education and Attention Control Treatment

Education and Attention Control Treatment

Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.


Participant Flow:   Overall Study
    Behavioral and Nutrition Treatment   Education and Attention Control Treatment
STARTED   36   42 
COMPLETED   36   42 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Behavioral and Nutrition Treatment

Behavioral and Nutrition Treatment

Behavioral plus Nutrition Treatment: This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills.

Education and Attention Control Treatment

Education and Attention Control Treatment

Attention Control Treatment: This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.

Total Total of all reporting groups

Baseline Measures
   Behavioral and Nutrition Treatment   Education and Attention Control Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   42   78 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.8  (1.2)   3.7  (1.3)   3.8  (1.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  55.6%      23  54.8%      43  55.1% 
Male      16  44.4%      19  45.2%      35  44.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Non-Hispanic   35   40   75 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race-White   35   42   77 
Energy Intake (kcal/day) 
[Units: Calories/day (kcal/day)]
Mean (Standard Deviation)
 1462  (330)   1461  (332)   1462  (329) 
Weight for Age Z score [1] 
[Units: Z-score]
Mean (Standard Deviation)
 -0.36  (0.75)   -0.51  (.85)   -0.44  (0.81) 
[1] Weight for age Z score was calculated using the mean measurement and the Centers for Disease Control and Prevention Anthropometric Software Program. The z score is a measure of the number of standard deviations that an observation is above or below the mean. A positive z score indicates that the observation is above the mean, a negative z score that the observation is below the mean.


  Outcome Measures

1.  Primary:   Change in Energy Intake From Baseline to Post Treatment   [ Time Frame: 6 months ]

2.  Primary:   Change in Weight for Age Z-Score (WAZ) From Baseline to Post Treatment   [ Time Frame: 6 months ]

3.  Primary:   Change in Height for Age Z-Score (HAZ) From Baseline to Follow Up   [ Time Frame: 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott Powers, PhD
Organization: Cincinnati Children's Hospital Medical Center
phone: 513-636-8106
e-mail: scott.powers@cchmc.org


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00241969     History of Changes
Other Study ID Numbers: DK 54915
R01DK054915 ( U.S. NIH Grant/Contract )
First Submitted: October 18, 2005
First Posted: October 19, 2005
Results First Submitted: August 21, 2017
Results First Posted: April 17, 2018
Last Update Posted: May 22, 2018