<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/NCT03250858</url>
  </required_header>
  <id_info>
    <org_study_id>13/17</org_study_id>
    <nct_id>NCT03250858</nct_id>
  </id_info>
  <brief_title>Online Nutrition Advice in the UK (EatWellUK)</brief_title>
  <acronym>EatWellUK</acronym>
  <official_title>Randomized Control Trial to Evaluate the Effectiveness of Online Nutrition Advice in the UK (The EatWellUK Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Reading</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Reading</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>
      The EatWellUK study aims to investigate the effectiveness of a mobile web application&#xD;
      (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet&#xD;
      quality.&#xD;
&#xD;
      Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has&#xD;
      been designed for better usability) and dietary feedback is derived according to adherence to&#xD;
      an 11-item modified US Alternative Healthy Eating Index (m-AHEI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary intake</measure>
    <time_frame>baseline, 6 weeks, 12 weeks</time_frame>
    <description>Change from baseline in dietary intake at 6 and 12 weeks assessed via a Food Frequency Questionnaire (FFQ). An 11-item modified US Alternative Healthy Eating Index (m-AHEI), which is calculated from the results of the FFQ, will be used to quantify the dietary intake changes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>baseline, 6 weeks, 12 weeks</time_frame>
    <description>Change from baseline in self-reported weight (kg) at 6 and 12 weeks. Weight variation will be combined with height (constant for adults) and also reported as BMI variation (kg/mˆ2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>baseline, 6 weeks, 12 weeks</time_frame>
    <description>Change from baseline in self-reported physical activity (Baecke questionnaire) at 6 and 12 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">324</enrollment>
  <condition>Dietary Modification</condition>
  <condition>Dietary Habits</condition>
  <arm_group>
    <arm_group_label>Non-personalised advice</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group. Online (web-based) delivery of non-personalised dietary, weight and physical activity advice based on the UK general health guidelines.&#xD;
This is an online trial and this arm will be using the e-Nutri web application. Participants in this group will receive online general recommendations (non-personalised).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Personalised advice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Online (web-based) delivery of personalised dietary, weight and physical activity advice based on the individual's dietary intake, weight and physical activity levels, generated by the e-Nutri web application. Participants in this group will receive online personalised reports.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Personalised advice</intervention_name>
    <description>Provision of online personalised advice on dietary intake, weight and physical activity levels. Personalised recommendations for improved food choice based on adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI), for weight based on ideal BMI range and for physical activity based on the Baecke questionnaire/results.</description>
    <arm_group_label>Personalised advice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-personalised advice</intervention_name>
    <description>Provision of online non-personalised advice on dietary intake, weight and physical activity levels. Non-personalized dietary advice for improved food choice based on standard population health guidelines.</description>
    <arm_group_label>Non-personalised advice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged &gt; 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  aged &lt; 18 years old&#xD;
&#xD;
          -  not living in the UK&#xD;
&#xD;
          -  pregnant/lactating&#xD;
&#xD;
          -  no or limited access to internet&#xD;
&#xD;
          -  following a prescribed diet for any reason&#xD;
&#xD;
          -  intolerance or food allergy&#xD;
&#xD;
          -  subject with diabetes, or any other metabolic disorder or illness that alters&#xD;
             nutritional requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Reading</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG6 6AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Reading</investigator_affiliation>
    <investigator_full_name>Julie Lovegrove</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Personalised nutrition</keyword>
  <keyword>Mobile web application</keyword>
  <!-- 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/NCT03250858
org study id: 13/17
nct id: NCT03250858
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The EatWellUK study aims to investigate the effectiveness of a mobile web application
      (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet
      quality.

      Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has
      been designed for better usability) and dietary feedback is derived according to adherence to
      an 11-item modified US Alternative Healthy Eating Index (m-AHEI).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Dietary intake
time frame: baseline, 6 weeks, 12 weeks
description: Change from baseline in dietary intake at 6 and 12 weeks assessed via a Food Frequency Questionnaire (FFQ). An 11-item modified US Alternative Healthy Eating Index (m-AHEI), which is calculated from the results of the FFQ, will be used to quantify the dietary intake changes.
measure: Weight
time frame: baseline, 6 weeks, 12 weeks
description: Change from baseline in self-reported weight (kg) at 6 and 12 weeks. Weight variation will be combined with height (constant for adults) and also reported as BMI variation (kg/mˆ2).
measure: Physical activity
time frame: baseline, 6 weeks, 12 weeks
description: Change from baseline in self-reported physical activity (Baecke questionnaire) at 6 and 12 weeks
arm group label: Non-personalised advice
arm group type: Placebo Comparator
description: Control group. Online (web-based) delivery of non-personalised dietary, weight and physical activity advice based on the UK general health guidelines.
This is an online trial and this arm will be using the e-Nutri web application. Participants in this group will receive online general recommendations (non-personalised).
arm group label: Personalised advice
arm group type: Experimental
description: Online (web-based) delivery of personalised dietary, weight and physical activity advice based on the individual's dietary intake, weight and physical activity levels, generated by the e-Nutri web application. Participants in this group will receive online personalised reports.
intervention type: Behavioral
intervention name: Personalised advice
description: Provision of online personalised advice on dietary intake, weight and physical activity levels. Personalised recommendations for improved food choice based on adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI), for weight based on ideal BMI range and for physical activity based on the Baecke questionnaire/results.
arm group label: Personalised advice
intervention type: Behavioral
intervention name: Non-personalised advice
description: Provision of online non-personalised advice on dietary intake, weight and physical activity levels. Non-personalized dietary advice for improved food choice based on standard population health guidelines.
arm group label: Non-personalised advice
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Reading
investigator full name: Julie Lovegrove
investigator title: Professor