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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00241969 |
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 |
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Cystic Fibrosis Pancreatic Cystic Fibrosis |
Behavioral: Behavioral plus Nutrition Treatment Behavioral: Attention Control Treatment |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Site Randomized Clinical Trial of Behavioral and Nutrition Treatment Designed to Help Preschoolers With Cystic Fibrosis Optimize Growth |
Estimated Enrollment: | 100 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
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.
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2: Active Comparator |
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.
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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:
From three accredited CF Centers in Ohio (Cincinnati, Columbus, Cleveland), 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.
Ages Eligible for Study: | 2 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Leigh A Chamberlin, MEd | 513-636-9739 | lacham@cchmc.org |
Contact: Stephanie M Sullivan, BS | 513-636-7735 | stephanie.sullivan@cchmc.org |
United States, Michigan | |
University of Michigan Health System | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Jennifer Butcher, PhD 734-936-4207 jennbutch@med.umich.edu | |
Contact: Samya Nasr, MD 734-764-4123 snasr@med.umich.edu | |
Principal Investigator: Samya Nasr, MD | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Leigh A Chamberlin, MEd 513-636-9739 lacham@cchmc.org | |
Contact: Stephanie M Sullivan, BS 513-636-7735 stephanie.sullivan@cchmc.org | |
Principal Investigator: Scott W Powers, PhD | |
Nationwide Children's Hospital | Recruiting |
Columbus, Ohio, United States, 43205 | |
Contact: Andrea King, PsyD 614-722-4734 andrea.king@nationwidechildrens.org | |
Contact: Kathy L. Lemanek, PhD 614-722-4711 LemanekK@nationwidechildrens.org | |
Principal Investigator: Kathleen L Lemanek, PhD | |
Rainbows and Babies Children's Hospital | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Roberta Ksenich, RN 216-844-5733 roberta.ksenich@case.edu | |
Contact: Michael W Konstan, MD 216-844-1997 Michael.Konstan@case.edu | |
Principal Investigator: Michael W Konstan, MD |
Principal Investigator: | Scott W. Powers, PhD | Children's Hospital Medical Center, Cincinnati |
Responsible Party: | Cincinnati Children's Hospital Medical Center ( Scott W. Powers, PhD ) |
Study ID Numbers: | DK 54915 |
Study First Received: | October 18, 2005 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00241969 History of Changes |
Health Authority: | United States: Federal Government |
nutrition therapy preschool children cystic fibrosis |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |