<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01686672</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0467</org_study_id>
    <nct_id>NCT01686672</nct_id>
  </id_info>
  <brief_title>Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis</brief_title>
  <acronym>Be In Charge</acronym>
  <official_title>Web-based Delivery of Effective Treatment for Growth in Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will demonstrate feasibility and collect pilot data via a pilot randomized trial&#xD;
      of 20 participants on the effectiveness of a web-based delivery system of behavioral plus&#xD;
      nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of&#xD;
      age that has been found to be efficacious in face to face delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Optimizing nutritional status and growth improves health outcomes and survival in children&#xD;
      with cystic fibrosis (CF). Better pulmonary function, as measured by forced expiratory rate&#xD;
      in 1 second (FEV1), is associated with body mass index (BMI) above the 50th percentile for&#xD;
      age and gender for children with CF1. Evidence based practice guidelines recommend that&#xD;
      nutritional treatment for children with CF ages 2 to 20 years should aim to achieve and&#xD;
      maintain a BMI &gt; 50th percentile, however across 117 CF centers in the United States 57% of&#xD;
      girls and 56% of boys failed to meet this recommendation1. The investigators have developed a&#xD;
      highly effective behavioral plus nutrition intervention (BE IN CHARGE) and demonstrated its&#xD;
      efficacy when delivered face-to-face to produce weight gain and its superiority over&#xD;
      nutrition education alone. Although endorsed by the CF Foundation as an evidence-based&#xD;
      treatment, it is not available to most CF Centers or families due to lack of trained&#xD;
      personnel, cost, and distance issues. With funding from the CF Foundation the investigators&#xD;
      developed a web-based delivery system of their efficacious behavioral plus nutrition&#xD;
      intervention for parents of children with CF ages 4 to 9 years of age. Using a Place Outcomes&#xD;
      Award the investigators have conducted beta testing of the web-intervention and made&#xD;
      appropriate modifications. The current study represents the next steps in refining and&#xD;
      testing our web-based intervention. This study will demonstrate feasibility and collect pilot&#xD;
      data on the effectiveness of the intervention in a pilot randomized trial of 20 treatment&#xD;
      naïve participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Average Daily Caloric Intake</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>Change in average daily caloric intake at baseline and 10 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Weight</measure>
    <time_frame>Baseline and 10 weeks</time_frame>
    <description>Change in weight from baseline to 10 weeks</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Use of web-based intervention</measure>
    <time_frame>10 weeks</time_frame>
    <description>Ongoing use of web-intervention collected electronically via the web to include sign on, duration of time on web, page views, and completion of activities on the web-site</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment Satisfaction</measure>
    <time_frame>10 weeks</time_frame>
    <description>Assessment of participant's satisfaction with the intervention and web-site</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Web Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BeInCharge has two components: an electronic diet tracker and a 7 session intervention. The 7 treatment sessions are designed to be completed over a 7 to 10 week period. Each treatment module includes both a nutrition education and child behavior management component. Treatment sessions should be completed every 7 to 10 days, while the electronic diet tracker requires daily input.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive usual care and be assessed at baseline and week 10 for study outcomes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Web Intervention</intervention_name>
    <description>Behavioral</description>
    <arm_group_label>Web Intervention</arm_group_label>
    <other_name>Be In Charge</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Cystic Fibrosis&#xD;
&#xD;
          -  Ages 4 to 9 year&#xD;
&#xD;
          -  below the 50th percentile for body mass index for age and gender&#xD;
&#xD;
          -  and their parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medical condition that would affect diet or growth (e.g., type 1 diabetes mellitus)&#xD;
&#xD;
          -  significant developmental delays&#xD;
&#xD;
          -  a sputum culture positive for Burkholderia cepacia&#xD;
&#xD;
          -  a forced expiratory volume in the first second of expiration (FEV1) of less than 40%&#xD;
&#xD;
          -  receiving enteral or parenteral nutrition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Stark, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>October 17, 2014</last_update_submitted>
  <last_update_submitted_qc>October 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cystic Fibrosis</keyword>
  <keyword>Behavioral Intervention</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01686672
org study id: 2012-0467
nct id: NCT01686672
lead sponsor: 
has dmc: No
This study will demonstrate feasibility and collect pilot data via a pilot randomized trial
      of 20 participants on the effectiveness of a web-based delivery system of behavioral plus
      nutrition intervention for parents of children with Cystic Fibrosis (CF) ages 4 to 9 years of
      age that has been found to be efficacious in face to face delivery.
Optimizing nutritional status and growth improves health outcomes and survival in children
      with cystic fibrosis (CF). Better pulmonary function, as measured by forced expiratory rate
      in 1 second (FEV1), is associated with body mass index (BMI) above the 50th percentile for
      age and gender for children with CF1. Evidence based practice guidelines recommend that
      nutritional treatment for children with CF ages 2 to 20 years should aim to achieve and
      maintain a BMI > 50th percentile, however across 117 CF centers in the United States 57% of
      girls and 56% of boys failed to meet this recommendation1. The investigators have developed a
      highly effective behavioral plus nutrition intervention (BE IN CHARGE) and demonstrated its
      efficacy when delivered face-to-face to produce weight gain and its superiority over
      nutrition education alone. Although endorsed by the CF Foundation as an evidence-based
      treatment, it is not available to most CF Centers or families due to lack of trained
      personnel, cost, and distance issues. With funding from the CF Foundation the investigators
      developed a web-based delivery system of their efficacious behavioral plus nutrition
      intervention for parents of children with CF ages 4 to 9 years of age. Using a Place Outcomes
      Award the investigators have conducted beta testing of the web-intervention and made
      appropriate modifications. The current study represents the next steps in refining and
      testing our web-based intervention. This study will demonstrate feasibility and collect pilot
      data on the effectiveness of the intervention in a pilot randomized trial of 20 treatment
      naïve participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Average Daily Caloric Intake
time frame: Baseline and 10 weeks
description: Change in average daily caloric intake at baseline and 10 weeks.
measure: Change in Weight
time frame: Baseline and 10 weeks
description: Change in weight from baseline to 10 weeks
measure: Use of web-based intervention
time frame: 10 weeks
description: Ongoing use of web-intervention collected electronically via the web to include sign on, duration of time on web, page views, and completion of activities on the web-site
measure: Treatment Satisfaction
time frame: 10 weeks
description: Assessment of participant's satisfaction with the intervention and web-site
arm group label: Web Intervention
arm group type: Experimental
description: BeInCharge has two components: an electronic diet tracker and a 7 session intervention. The 7 treatment sessions are designed to be completed over a 7 to 10 week period. Each treatment module includes both a nutrition education and child behavior management component. Treatment sessions should be completed every 7 to 10 days, while the electronic diet tracker requires daily input.
arm group label: Usual Care
arm group type: No Intervention
description: Participants will receive usual care and be assessed at baseline and week 10 for study outcomes.
intervention type: Behavioral
intervention name: Web Intervention
description: Behavioral
arm group label: Web Intervention
other name: Be In Charge
criteria: 
gender: All
minimum age: 4 Years
maximum age: 9 Years
healthy volunteers: No
last name: Lori Stark, Ph.D.
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis