xml: <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/NCT06016959</url>
    </required_header>
    <id_info>
      <org_study_id>327224</org_study_id>
      <nct_id>NCT06016959</nct_id>
    </id_info>
    <brief_title>Specialist Dietetic Intervention in Malnourished Patients With Fibrotic ILD: a Randomised Controlled Pilot Trial</brief_title>
    <acronym>DT-ILD</acronym>
    <official_title>Specialist Dietetic Intervention in Malnourished Patients With Fibrotic ILD: a Randomised Controlled Pilot Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Royal Brompton &amp; Harefield 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>
        Malnutrition occurs when the body receives too few nutrients, resulting in health problems&#xD;
        such as weight loss. The consequences of malnutrition are worrying as they include lung&#xD;
        failure, infection, and pressure ulcers.&#xD;
  &#xD;
        Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause&#xD;
        scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and&#xD;
        burning off energy. Additionally, medications called anti-fibrotic agents are used to slow&#xD;
        disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting&#xD;
        and weight loss which can result in malnutrition.&#xD;
  &#xD;
        Malnutrition occurs in ILD in approximately half of patients. This is important because the&#xD;
        main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes&#xD;
        into consideration your weight against your height, are linked with worse outcomes in ILD.&#xD;
        Malnutrition in ILD can also reduce eligibility for lung transplant and can impact&#xD;
        tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is&#xD;
        limited.&#xD;
  &#xD;
        Dietitians play a key role in diagnosis and treatment of malnutrition. This is because&#xD;
        dietary counselling by a dietitian has been shown to increase quality of life and intake of&#xD;
        energy in other chronic diseases. There are currently no studies documenting the benefits of&#xD;
        dietetic intervention in patients with ILD.&#xD;
  &#xD;
        We propose to undertake the first feasibility study in this area. A feasibility study is a&#xD;
        first step trial which investigates whether a study can &amp; should be done. The main aims of&#xD;
        this study are:&#xD;
  &#xD;
          1. How easy it is to recruit ILD patients to see a dietitian&#xD;
  &#xD;
          2. Whether patients will attend dietetic appointments&#xD;
  &#xD;
          3. Whether food/nutrient intake is increased following dietetic intervention&#xD;
  &#xD;
          4. How acceptable is dietetic intervention to ILD patients As well as these main aims, this&#xD;
             study will also provide initial information about whether dietetic intervention&#xD;
             stabilises weight, BMI &amp; quality of life.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 28, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 28, 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>8 months</time_frame>
      <description>Number individuals recruited/Number individuals contacted</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Completion rate</measure>
      <time_frame>3 months</time_frame>
      <description>Number individuals completing study/Number individuals randomised</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compliance</measure>
      <time_frame>Defined by increased energy &amp; protein intake versus run-in (three-day diet-diaries).</time_frame>
      <description>3 months</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nutritional status (Malnutrition)</measure>
      <time_frame>3 months</time_frame>
      <description>PG-Subjective Global Assessment (SGA) which is a nutrition assessment tool using clinical parameters including weight loss, GI symptoms &amp; functional capacity to diagnose malnutrition (Bauer et al., 2011).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nutritional status (gastrointestinal related symptoms)</measure>
      <time_frame>3 months</time_frame>
      <description>Gastrointestinal symptoms will be measured via the Gastrointestinal Symptom Rating Scale (GSRS) to further understand severity and impact of gastrointestinal related symptoms. (Svedlund et al., 1988)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometrics (weight)</measure>
      <time_frame>3 months</time_frame>
      <description>Weight (kg) will be measured by VitaFit™ FCC/CE certified digital weighing scales provided during the first appointment or delivered at home, measured to an accuracy of 0.05kg. Dietitian led support for their use will be available.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometrics (height)</measure>
      <time_frame>3 months</time_frame>
      <description>Height (m) will be derived from the most recent lung function reports.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometrics (Body Mass Index)</measure>
      <time_frame>3 months</time_frame>
      <description>With the anthropometrics measured weight (kg) and height (m), this will be used to calculate Body Mass Index (BMI (kg/m2)).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Handgrip strength</measure>
      <time_frame>3 months</time_frame>
      <description>Optimum nutrition can support maintenance of muscle to support activities of daily living. A CAMRY™ digital hand dynamometer will be delivered at home. HGS (kg) measures maximum voluntary muscle strength by squeezing the dynamometer providing a grip measurement accurate to 0.1kg.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life (QoL)</measure>
      <time_frame>3 months</time_frame>
      <description>Improved nutrition status may positively impact QoL. The King's Brief Interstitial Lung Disease Questionnaire (K-BILD), a 15-widely validated ILD-specific QoL questionnaire, will be used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Energy and Protein intake</measure>
      <time_frame>3 months</time_frame>
      <description>Participants will undertake a three-day diet diary at baseline and at 3 months to measure intake of macro and micronutrients will be calculated by using the software NutriticsTM, including daily total energy and protein intake as well as other nutrients, if necessary.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Interstitial Lung Disease</condition>
    <arm_group>
      <arm_group_label>Individualised dietetic advice</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive 5 sessions receiving individualised nutritional counselling advice from a registered dietitian.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diet sheet</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive a diet sheet around poor appetite.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dietetic intervention</intervention_name>
      <description>Dietetic intervention involves individualised and tailored dietary advice to patients struggling with their nutrition. This includes optimising energy and protein intake to improve malnutrition &amp; also giving dietary advice to support with nutrition impact symptoms e.g. bloating.</description>
      <arm_group_label>Individualised dietetic advice</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Diet sheet (placebo)</intervention_name>
      <description>Patients randomised into the group receiving a diet sheet will be sent out Royal Brompton &amp; Harefield Hospital's Poor Appetite diet booklet which involves general strategies to improve nutritional status (energy and protein)</description>
      <arm_group_label>Diet sheet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI ≤ 20kg/m2, or if aged &gt;75, BMI ≤ 21 (Righini et al., 2013)&#xD;
  &#xD;
            -  Over the past 12 months, unintentional weight loss ≥ 5% of body weight, regardless of&#xD;
               baseline BMI or weight loss &gt;2 kg if BMI is normal.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Co-morbidities currently requiring a specialised diet (including enteral feeding)&#xD;
  &#xD;
            -  End of life care (estimated less than 6 weeks left to live)&#xD;
  &#xD;
            -  Expected introduction of anti-fibrotic or immunosuppressive treatment or&#xD;
               introduction/increase corticosteroid dose during trial period&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Unable to give consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Rasleen Kahai</last_name>
      <phone>020 7352 8121</phone>
      <email>r.kahai@rbht.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elisabetta Renzoni</last_name>
      <phone>020 7352 8121</phone>
      <email>e.renzoni@rbht.nhs.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Royal Brompton Hospital</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rasleen Kahai</last_name>
        <phone>02073528121</phone>
        <phone_ext>84454</phone_ext>
        <email>r.kahai@rbht.nhs.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016959
  org study id: 327224
  nct id: NCT06016959
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Malnutrition occurs when the body receives too few nutrients, resulting in health problems
        such as weight loss. The consequences of malnutrition are worrying as they include lung
        failure, infection, and pressure ulcers.
  
        Interstitial Lung Disease (ILD) is a term used for a group of diseases which can cause
        scarring of the lungs. Having ILD can cause malnutrition due to the lungs working hard and
        burning off energy. Additionally, medications called anti-fibrotic agents are used to slow
        disease progression. However, side effects include poor appetite, diarrhoea, nausea, vomiting
        and weight loss which can result in malnutrition.
  
        Malnutrition occurs in ILD in approximately half of patients. This is important because the
        main signs of malnutrition such as weight loss and a low Body Mass Index (BMI), which takes
        into consideration your weight against your height, are linked with worse outcomes in ILD.
        Malnutrition in ILD can also reduce eligibility for lung transplant and can impact
        tolerability of anti-fibrotic agents. Research into treatment of malnutrition in ILD is
        limited.
  
        Dietitians play a key role in diagnosis and treatment of malnutrition. This is because
        dietary counselling by a dietitian has been shown to increase quality of life and intake of
        energy in other chronic diseases. There are currently no studies documenting the benefits of
        dietetic intervention in patients with ILD.
  
        We propose to undertake the first feasibility study in this area. A feasibility study is a
        first step trial which investigates whether a study can & should be done. The main aims of
        this study are:
  
          1. How easy it is to recruit ILD patients to see a dietitian
  
          2. Whether patients will attend dietetic appointments
  
          3. Whether food/nutrient intake is increased following dietetic intervention
  
          4. How acceptable is dietetic intervention to ILD patients As well as these main aims, this
             study will also provide initial information about whether dietetic intervention
             stabilises weight, BMI & quality of life.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Recruitment rate
  time frame: 8 months
  description: Number individuals recruited/Number individuals contacted
  measure: Completion rate
  time frame: 3 months
  description: Number individuals completing study/Number individuals randomised
  measure: Compliance
  time frame: Defined by increased energy & protein intake versus run-in (three-day diet-diaries).
  description: 3 months
  measure: Nutritional status (Malnutrition)
  time frame: 3 months
  description: PG-Subjective Global Assessment (SGA) which is a nutrition assessment tool using clinical parameters including weight loss, GI symptoms & functional capacity to diagnose malnutrition (Bauer et al., 2011).
  measure: Nutritional status (gastrointestinal related symptoms)
  time frame: 3 months
  description: Gastrointestinal symptoms will be measured via the Gastrointestinal Symptom Rating Scale (GSRS) to further understand severity and impact of gastrointestinal related symptoms. (Svedlund et al., 1988)
  measure: Anthropometrics (weight)
  time frame: 3 months
  description: Weight (kg) will be measured by VitaFit™ FCC/CE certified digital weighing scales provided during the first appointment or delivered at home, measured to an accuracy of 0.05kg. Dietitian led support for their use will be available.
  measure: Anthropometrics (height)
  time frame: 3 months
  description: Height (m) will be derived from the most recent lung function reports.
  measure: Anthropometrics (Body Mass Index)
  time frame: 3 months
  description: With the anthropometrics measured weight (kg) and height (m), this will be used to calculate Body Mass Index (BMI (kg/m2)).
  measure: Handgrip strength
  time frame: 3 months
  description: Optimum nutrition can support maintenance of muscle to support activities of daily living. A CAMRY™ digital hand dynamometer will be delivered at home. HGS (kg) measures maximum voluntary muscle strength by squeezing the dynamometer providing a grip measurement accurate to 0.1kg.
  measure: Quality of Life (QoL)
  time frame: 3 months
  description: Improved nutrition status may positively impact QoL. The King's Brief Interstitial Lung Disease Questionnaire (K-BILD), a 15-widely validated ILD-specific QoL questionnaire, will be used.
  measure: Energy and Protein intake
  time frame: 3 months
  description: Participants will undertake a three-day diet diary at baseline and at 3 months to measure intake of macro and micronutrients will be calculated by using the software NutriticsTM, including daily total energy and protein intake as well as other nutrients, if necessary.
  arm group label: Individualised dietetic advice
  arm group type: Experimental
  description: Participants will receive 5 sessions receiving individualised nutritional counselling advice from a registered dietitian.
  arm group label: Diet sheet
  arm group type: Placebo Comparator
  description: Participants will receive a diet sheet around poor appetite.
  intervention type: Other
  intervention name: Dietetic intervention
  description: Dietetic intervention involves individualised and tailored dietary advice to patients struggling with their nutrition. This includes optimising energy and protein intake to improve malnutrition & also giving dietary advice to support with nutrition impact symptoms e.g. bloating.
  arm group label: Individualised dietetic advice
  intervention type: Other
  intervention name: Diet sheet (placebo)
  description: Patients randomised into the group receiving a diet sheet will be sent out Royal Brompton & Harefield Hospital's Poor Appetite diet booklet which involves general strategies to improve nutritional status (energy and protein)
  arm group label: Diet sheet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rasleen Kahai
  phone: 020 7352 8121
  email: r.kahai@rbht.nhs.uk
  last name: Elisabetta Renzoni
  phone: 020 7352 8121
  email: e.renzoni@rbht.nhs.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  sharing ipd: No