Behavioral & Nutritional Treatment to Help CF Preschoolers Grow
|Cystic Fibrosis Pancreatic Cystic Fibrosis||Behavioral: Behavioral plus Nutrition Treatment Behavioral: Attention Control Treatment||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multi-Site Randomized Clinical Trial of Behavioral and Nutrition Treatment Designed to Help Preschoolers With Cystic Fibrosis Optimize Growth|
- Energy intake [ Time Frame: 6 months ]Examine change in energy intake between baseline and post treatment (6 months)
- Energy Intake [ Time Frame: 18 months ]Examine change in energy intake between baseline and follow up (18 months)
- Weight for age z score [ Time Frame: 6 months ]Examine change in weight for age z score between baseline and post treatment (6 months)
- Weight for age z score [ Time Frame: 18 months ]Examine change in energy intake between baseline and follow up (18 months)
- Height for age Z Score [ Time Frame: 18 months ]Examine change in height for age Z score between baseline and follow up (18 months)
|Study Start Date:||January 2006|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Behavioral and Nutrition Treatment
Behavioral: 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.
Active Comparator: 2
Education and Attention Control Treatment
Behavioral: 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.
Evidence-based nutritional interventions that achieve and sustain optimal growth in young children with cystic fibrosis (CF) do not exist, despite an urgent need. Such an intervention could positively change the course of clinical lung disease and enhance survival for these children. The primary objective of this NIH funded clinical trial is to conduct a multi-center, randomized, controlled trial comparing two interventions: a behavioral plus nutrition intervention to a nutrition (attention control) intervention. All subjects will receive nutritional care consistent with the 2001 CF Consensus Conference guidelines for pediatric nutrition.
The specific aims are to:
- determine the impact of the behavioral intervention on energy intake and weight gain;
- examine the durability of the behavioral intervention's impact on growth (weight and height) one year following treatment; and
- explore the relation between physical activity and growth. The central hypothesis is that behavioral intervention will lead to better growth as measured by change in weight and height for age z scores.
From three CF Centers in Ohio, (Cincinnati Children's, Columbus Children's, Rainbow Babies and Children's Hospital in Cleveland), two referral centers in Ohio (Dayton Children's and Akron Children's), one CF Center in Michigan (University of Michigan-Ann Arbor), and one CF Center in Arizona (University of Arizona-Tucson), 100 preschoolers with CF and pancreatic insufficiency age 2 to 6 years will be randomized to one of the two conditions. The two groups will be stratified so that they are similar at the initiation of treatment on weight for age z score.
Other critical variables such as history of Pseudomonas aeruginosa infection and gender will be used as covariates in the statistical analysis plan. Outcome data (energy intake measured by 7-day diet record, weight, height) will be obtained at baseline, post-treatment (6 months), and after a 12-month follow-up (18 months post baseline).
Secondary measures will include body mass index, body composition measured by dual energy x-ray absorptiometry (DXA) and skinfolds, and growth velocity. Behavioral treatment will maximize adherence to a high energy diet and enzyme replacement therapy, and motivate children to increase their energy intake. It involves 7 weekly sessions followed by 4 monthly sessions. The attention condition controls for time of contact and number of assessments conducted.
This study advances the investigation of early nutritional interventions for young children with CF and directly addresses the need for controlled, longitudinal assessment of behavioral intervention on growth. The long-range goal is to change the standard of nutritional care for young children with CF because behavioral intervention leads to optimal growth and ultimately improves lung health and survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241969
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85724|
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Rainbows and Babies Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Scott W. Powers, PhD||Children's Hospital Medical Center, Cincinnati|