<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/NCT03782909</url>
  </required_header>
  <id_info>
    <org_study_id>STH20240</org_study_id>
    <nct_id>NCT03782909</nct_id>
  </id_info>
  <brief_title>Evaluation of a Behavioural Intervention Using App Technology in CF</brief_title>
  <acronym>EAT-CF</acronym>
  <official_title>Evaluation of a Behavioural Intervention Using App Technology in Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to&#xD;
      become clogged with thick, sticky mucus. This leads to recurrent chest infections and reduced&#xD;
      nutrient absorption from food. The average age at death is 31 years, usually from respiratory&#xD;
      failure. The nutritional status of people with CF (PWCF) is important to help them live&#xD;
      healthier and longer.&#xD;
&#xD;
      It is recommended that adults with CF achieve a BMI of 23 for males and 22 for females.&#xD;
      However, fewer than 50% of adults with CF achieved that target BMI despite effective&#xD;
      nutritional support to help weight gain. There is a clear need for a behavioural intervention&#xD;
      that can help PWCF use the available nutritional support.&#xD;
&#xD;
      This is a feasibility study to try out a multi-component behavioural intervention supported&#xD;
      by a nutrition app. The intervention is designed to help PWCF use their nutritional support&#xD;
      to gain weight. It will focus on testing the methods and procedures to be used on a larger&#xD;
      scale, improving the behavioural intervention and estimating how many people are needed for&#xD;
      the larger trial.&#xD;
&#xD;
      Eligible patients will be invited to participate, and the investigators anticipate recruiting&#xD;
      6 participants. The participants will have 6 weeks of intensive intervention, which will&#xD;
      include a mix of clinic visits, home visits and telephone calls followed by 6 weeks of&#xD;
      maintenance phase. Data will be collected during clinic visits at baseline, week 6 and week&#xD;
      12 along with weight monitoring at home.&#xD;
&#xD;
      The investigators will interview each participant at the end of the study period to improve&#xD;
      the intervention and study processes based on participant feedback.&#xD;
&#xD;
      The investigators hypothesised that using a nutrition app, along with regular input from a&#xD;
      dietitian, will help PWCF to use the available nutritional support.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 8, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who accepted invitation to participate as a marker of feasibility</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participants' opinion about the behavioural intervention</measure>
    <time_frame>3 months</time_frame>
    <description>A semi-structured interview will be used for thematic analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant attrition rate and phases of the study whereby the attrition occurs</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' opinion about the study processes</measure>
    <time_frame>3 months</time_frame>
    <description>A semi-structured interview will be used for thematic analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants' suggestions for further improvement of the intervention and study processes</measure>
    <time_frame>3 months</time_frame>
    <description>A semi-structured interview will be used for thematic analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resources (time) needed by the investigators to deliver the intervention</measure>
    <time_frame>3 months</time_frame>
    <description>Time will be used as a measurement tool to quantify total time required to deliver the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of days with missing nutritional data, as a marker of feasibility</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Behaviour change intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behaviour change intervention</intervention_name>
    <description>The behaviour change intervention consists of;&#xD;
Feedback via an app based food diary&#xD;
Coaching with problem solving and implementation plans&#xD;
The intensive phase consists of 2 home visits and 4 phone calls and the use of the app The maintenance phase consists of use of the app if the PWCF wishes to continue using it</description>
    <arm_group_label>Behaviour change intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult people with CF looked after at the Sheffield Adult CF Centre&#xD;
&#xD;
          -  best BMI of &lt;23 for males and &lt;22 for females between June 2018 and November 2018&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients in palliative phase of disease&#xD;
&#xD;
          -  patients who are pregnant&#xD;
&#xD;
          -  patients who have no capacity to consent to participate in the study&#xD;
&#xD;
          -  patients who are unable to communicate by telephone for coaching&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nutrition</keyword>
  <keyword>Weight</keyword>
  <keyword>BMI</keyword>
  <keyword>Behaviour change</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/NCT03782909
org study id: STH20240
nct id: NCT03782909
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to
      become clogged with thick, sticky mucus. This leads to recurrent chest infections and reduced
      nutrient absorption from food. The average age at death is 31 years, usually from respiratory
      failure. The nutritional status of people with CF (PWCF) is important to help them live
      healthier and longer.

      It is recommended that adults with CF achieve a BMI of 23 for males and 22 for females.
      However, fewer than 50% of adults with CF achieved that target BMI despite effective
      nutritional support to help weight gain. There is a clear need for a behavioural intervention
      that can help PWCF use the available nutritional support.

      This is a feasibility study to try out a multi-component behavioural intervention supported
      by a nutrition app. The intervention is designed to help PWCF use their nutritional support
      to gain weight. It will focus on testing the methods and procedures to be used on a larger
      scale, improving the behavioural intervention and estimating how many people are needed for
      the larger trial.

      Eligible patients will be invited to participate, and the investigators anticipate recruiting
      6 participants. The participants will have 6 weeks of intensive intervention, which will
      include a mix of clinic visits, home visits and telephone calls followed by 6 weeks of
      maintenance phase. Data will be collected during clinic visits at baseline, week 6 and week
      12 along with weight monitoring at home.

      The investigators will interview each participant at the end of the study period to improve
      the intervention and study processes based on participant feedback.

      The investigators hypothesised that using a nutrition app, along with regular input from a
      dietitian, will help PWCF to use the available nutritional support.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of patients who accepted invitation to participate as a marker of feasibility
time frame: 4 weeks
measure: Participants' opinion about the behavioural intervention
time frame: 3 months
description: A semi-structured interview will be used for thematic analysis
measure: Participant attrition rate and phases of the study whereby the attrition occurs
time frame: 3 months
measure: Participants' opinion about the study processes
time frame: 3 months
description: A semi-structured interview will be used for thematic analysis
measure: Participants' suggestions for further improvement of the intervention and study processes
time frame: 3 months
description: A semi-structured interview will be used for thematic analysis
measure: Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
time frame: 4 weeks
measure: Resources (time) needed by the investigators to deliver the intervention
time frame: 3 months
description: Time will be used as a measurement tool to quantify total time required to deliver the intervention
measure: Proportion of days with missing nutritional data, as a marker of feasibility
time frame: 3 months
arm group label: Behaviour change intervention
arm group type: Experimental
description: Intensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks
intervention type: Behavioral
intervention name: Behaviour change intervention
description: The behaviour change intervention consists of;
Feedback via an app based food diary
Coaching with problem solving and implementation plans
The intensive phase consists of 2 home visits and 4 phone calls and the use of the app The maintenance phase consists of use of the app if the PWCF wishes to continue using it
arm group label: Behaviour change intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis