Developing e-Health Systems to Improve Growth and Nutrition in CF
Condition: Cystic Fibrosis in Children
MeSH terms: Cystic Fibrosis
Study type: Interventional

Summary: 
      Being at or above the 50th percentile body mass index (BMI) for age and gender in children
      with cystic fibrosis (CF) is associated with better lung functioning as measured by FEV1, yet
      diet is one of the least adhered to components of the CF treatment regimen. Investigators at
      Cincinnati Children's Hospital Medical Center (CCHMC) have developed an efficacious
      behavioral plus nutrition education program (Be In Charge) that improves adherence to dietary
      recommendations, and promotes weight gain in children with CF.

      To make Be In Charge (BIC) widely available to families of children with CF ages 3 to 10
      years, the investigators translated the face-to-face intervention into a 10-week, web-based
      intervention (BeInCharge.org). The investigators tested it in a pilot study and the results
      were promising. In the first phase of the current study, the investigators worked with a team
      of clinicians, parents and technology developers to extend the usability and functionality of
      the web intervention, enable parent-clinician collaboration, and support concurrent use
      across multiple clinical sites. The long term goal of this research is to make BeInCharge.org
      available through CF Centers across the country to patients that would benefit in order to
      improve dietary adherence.

      The current phase of this protocol is a prospective, multicenter, nonrandomized study
      enrolling up to 150 parents of children with CF. Participants will complete the Be In Charge
      program outside of CF clinic on their own time. CF Center clinicians will be able to follow
      the participant's progress via the Be In Charge clinician dashboard. CF center clinicians
      will be asked to support participating families in completing the program as clinically
      appropriate.

      The primary study objective is to:

      1. Demonstrate preliminary effectiveness on weight and calorie intake outcomes when the Be In
      Charge program is integrated into clinical care with implementation support for care teams.

      The secondary study objectives are to:

        1. Develop a well-defined, tested set of implementation strategies consolidated into a
           change package and an optimized technology platform that will support a dissemination
           trial for spreading the Be In Charge program across CF Centers.

        2. Demonstrate that it is feasible and acceptable to use the Be In Charge program in
           clinical care and with fidelity to intervention parameters.

        3. Demonstrate sustainability of the Be In Charge program through effective use by
           participants and clinicians.
    


Intervention name(s): Be In Charge
Intervention type(s): Behavioral
Intervention description(s): comparison of pre and post-program weight and calorie intake
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition; Behavioral Intervention