Behavioral & Nutritional Treatment to Help CF Preschoolers Grow
Condition: Cystic Fibrosis; Pancreatic Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

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 intervention's 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 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 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.
    

Intervention name(s): Behavioral and Nutrition Treatment; Education and Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This intervention will combine individualized nutrition counseling that targets increasing energy and fat intake and parent training of effective behavioral child management skills. The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.; This intervention will provide information about a number of aspects of their child's CF care and also provides anticipatory guidance for preschoolers.The treatment is delivered through 8 weekly sessions followed by 4 monthly sessions, each lasting around 60 minutes.
Other intervention name(s): control arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: nutrition therapy; preschool children; cystic fibrosis