Behavioral & Nutritional Treatment to Help CF Preschoolers Grow

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00241969
First received: October 18, 2005
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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 intervention's impact on growth (weight and height) one year following treatment; and (c) explore the relation between physical activity and growth.


Condition Intervention Phase
Cystic Fibrosis
Pancreatic Cystic Fibrosis
Behavioral: Behavioral plus Nutrition Treatment
Behavioral: Attention Control Treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Energy intake [ Time Frame: baseline, 6 months and 18 months ] [ Designated as safety issue: No ]
  • Weight for age z score [ Time Frame: baseline, 6 months and 18 months ] [ Designated as safety issue: No ]
  • Height for age z score [ Time Frame: baseline, 6 months and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Enzyme adherence [ Time Frame: baseline, 6 months and 18 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: baseline, 6 months and 18 months ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: baseline, 6 months and 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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 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.

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 intervention's 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 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 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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed diagnosis of cystic fibrosis based upon 2 of the following: a. sweat chloride by quantitative pilocarpine electrophoresis ≥60 mEq/L, b. two clinical features consistent with CF, or c. genetic testing demonstrating two mutations associated with CF
  • confirmation of pancreatic insufficiency based upon fecal elastase of ≤ 100 micrograms per gram of stool (or an undetectable level)
  • age at enrollment to the trial of 2.0 years to 6.0 years
  • at least 6 months post CF diagnosis
  • consuming an unrestricted fat diet

Exclusion Criteria:

  • diagnosis of developmental delay (i.e., autism, cerebral palsy, or mental retardation)
  • receiving supplemental enteral nutrition via nasogastric tube, gastrostomy, or total parenteral nutrition
  • diagnosed with another disease/condition (e.g., insulin dependent diabetes, congenital heart disease, significant renal disease, history of bowel resection or short bowel syndrome, colonic strictures) known to affect growth
  • taking a medication (e.g., insulin, growth hormone, chronic use of systemic steroids) known to affect growth
  • screening assessment shows genetic potential for height as acceptable according to the 2001 Consensus Conference guidelines and diet diary indicates daily Dietary Reference Intake (DRI) of energy average of 140% or greater (DRI of 100% will be determined as the estimated energy requirement [EER] based upon the child's age, gender, and an active physical activity level
  • weight z score (age and gender adjusted) of > 1.0
  • prior participation in the pilot intervention studies conducted by the PI during the prior period of R01 funding or current participation in an intervention trial conducted by the CF TDN
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241969

Locations
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
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Scott W. Powers, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Additional Information:
Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00241969     History of Changes
Other Study ID Numbers: DK 54915, R01DK054915
Study First Received: October 18, 2005
Last Updated: January 29, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Hospital Medical Center, Cincinnati:
nutrition therapy
preschool children
cystic fibrosis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 22, 2014