Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00241969
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2005-10-18
Brief Title:
Behavioral Nutritional Treatment to Help CF Preschoolers Grow
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
A Multi-Site Randomized Clinical Trial of Behavioral and Nutrition Treatment Designed to Help Preschoolers With Cystic Fibrosis Optimize Growth
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 intervention This study will a determine the impact of the behavioral intervention on energy intake and weight gain b examine the durability of the behavioral interventions impact on growth weight and height one year following treatment and c explore the relation between physical activity and growth
Detailed Description:
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
1 determine the impact of the behavioral intervention on energy intake and weight gain
2 examine the durability of the behavioral interventions impact on growth weight and height one year following treatment and
3 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 Childrens Columbus Childrens Rainbow Babies and Childrens Hospital in Cleveland two referral centers in Ohio Dayton Childrens and Akron Childrens 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
The specific aims are to
1 determine the impact of the behavioral intervention on energy intake and weight gain
2 examine the durability of the behavioral interventions impact on growth weight and height one year following treatment and
3 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 Childrens Columbus Childrens Rainbow Babies and Childrens Hospital in Cleveland two referral centers in Ohio Dayton Childrens and Akron Childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK054915 | NIH | None | httpsreporternihgovquickSearchR01DK054915 |