<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/NCT03265522</url>
  </required_header>
  <id_info>
    <org_study_id>16/NI/0105</org_study_id>
    <nct_id>NCT03265522</nct_id>
  </id_info>
  <brief_title>Tailored Mediterranean Lifestyle Education in Patients With Mild Cognitive Impairment</brief_title>
  <official_title>The Development and Pilot Testing of Tailored Mediterranean Lifestyle Education to Encourage Behaviour Change in Patients With Mild Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University, Belfast</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellcome Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University, Belfast</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>
      Evidence suggests that a Mediterranean diet can have a beneficial effect on brain health.&#xD;
      Mild cognitive impairment (MCI) describes problems with brain function such as difficulty&#xD;
      with day-to-day memory and concentration. It is at this stage that Mediterranean diet could&#xD;
      prove beneficial in terms of prevention.&#xD;
&#xD;
      Previous research by Queens University investigated the opinions of patients with MCI and&#xD;
      their care givers to inform the development of Mediterranean diet education material to&#xD;
      encourage behaviour change. The study suggested that MCI patients lacked awareness of the&#xD;
      link between Mediterranean diet and brain function, although were interested to learn more.&#xD;
      Feedback on the developed educational material was positive although there were suggested&#xD;
      improvements such as tailoring information to memory loss, a potential staged approach to&#xD;
      delivery and adaptations to the material content.&#xD;
&#xD;
      This present study aims to pilot test refined educational material among MCI participants to&#xD;
      evaluate the feasibility of encouraging dietary behaviour change among this patient group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to evaluate the feasibility of a theory-based, tailored Mediterranean&#xD;
      lifestyle education intervention to encourage behaviour change in patients with MCI. The&#xD;
      proposed study will be a 6 month RCT with a total of 60 MCI patients who will be randomised&#xD;
      to 1 of 3 groups:&#xD;
&#xD;
        1. Group 1 will receive the Mediterranean lifestyle education resource on one occasion at&#xD;
           baseline&#xD;
&#xD;
        2. Group 2 will receive the Mediterranean lifestyle education resource at monthly intervals&#xD;
           for 5 months accompanied by telephone feedback from the research dietitian&#xD;
&#xD;
        3. Group 3 will receive standard care (control group). Participants will receive the&#xD;
           Mediterranean lifestyle education resource after their final 6 month study visit (i.e.&#xD;
           delayed intervention).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Change in Mediterranean Diet Score (MDS) at 6 months</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Mediterranean dietary intake will be measured by a validated questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>RPAQ-Recent Physical Activity Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometric measurements</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Weight and height measurements to calculate BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Measured using a grip-strength dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Geriatric Depression Scale Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment (1)</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Assessment</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A comprehensive cognitive assessment will be performed, including: global cognition, motor skills, executive function episodic/visual memory, and information processing and sustained attention using a validated neuropsychological test battery (Cantab Cognitive Battery, Cambridge Cognition Ltd.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers to consuming a Mediterranean Diet questionnaire</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Sample</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A blood sample will be taken from participants to be stored for analysis of biomarkers of MD adherence and biomarkers of neurodegenerative disease risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment (2)</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>4-day Food Diary</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A food diary will be completed to assess compliance with a Mediterranean diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Lifestyle questionnaire</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A questionnaire to measure change in lifestyle behaviours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary Quality of Life questionnaire</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A questionnaire to measure dietary quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mediterranean Diet Knowledge questionnaire</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A questionnaire to measure participants Mediterranean diet knowledge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rand SF-36 HEALTH SURVEY</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A questionnaire to measure participants views and beliefs on health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Staging Algorithm Questionnaire</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A questionnaire to measure participants readiness to change their diet and lifestyle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mediterranean Diet self-efficacy questionnaire</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A questionnaire to measure participants self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mediterranean diet tolerance questionnaire</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>A questionnaire to measure tolerance to a Mediterranean diet</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Process Evaluation (1) - telephone contact evaluation</measure>
    <time_frame>up to 3 months post intervention</time_frame>
    <description>Determination individual participation and engagement with the intervention by reviewing telephone contact log record and telephone checklist evaluation</description>
  </other_outcome>
  <other_outcome>
    <measure>Process Evaluation (2) - study records</measure>
    <time_frame>up to 3 months post intervention</time_frame>
    <description>A review of study records- including attrition rates, reason for dropout</description>
  </other_outcome>
  <other_outcome>
    <measure>Process Evaluation (3) - structured interviews</measure>
    <time_frame>up to 3 months post intervention</time_frame>
    <description>Post intervention structured interviews for participant evaluation of the intervention programme and dietary educational materials</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Group 1: &quot;ThinkMed&quot; resource at baseline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The &quot;ThinkMed&quot; resource contains an information booklet, recipe books, menu plan cards, shopping list cards and goal setting cards. Participants will receive this resource on one occasion at baseline (n=20)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: &quot;ThinkMed&quot; resource (staged)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of participants will receive the &quot;ThinkMed&quot; resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian (n=20)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Standard Care (control) group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will continue with the standard care provided by their physician. Participants will receive the &quot;ThinkMed&quot; resource after their final 6 month study visit (i.e. delayed intervention) (n=20)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;ThinkMed&quot; resource at baseline</intervention_name>
    <description>The &quot;ThinkMed&quot; resource contains an information booklet, recipe books, menu plan cards, shopping list cards and goal setting cards. Participants will receive this resource on one occasion at baseline.</description>
    <arm_group_label>Group 1: &quot;ThinkMed&quot; resource at baseline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care Control</intervention_name>
    <description>Participants will continue with the standard care provided by their physician. Participants will receive the &quot;ThinkMed&quot; resource after their final 6 month study visit (i.e. delayed intervention).</description>
    <arm_group_label>Group 3: Standard Care (control) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>&quot;ThinkMed&quot; resource (staged)</intervention_name>
    <description>This group of participants will receive the &quot;ThinkMed&quot; resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian</description>
    <arm_group_label>Group 2: &quot;ThinkMed&quot; resource (staged)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Diagnosis of Mild Cognitive Impairment by their physician&#xD;
&#xD;
          -  Mediterranean diet score (MDS) less than or equal to 4 (Estruch et al., 2006)&#xD;
&#xD;
          -  Willing to make changes to their diet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of dementia&#xD;
&#xD;
          -  Patients with visual or English language impairment&#xD;
&#xD;
          -  Psychiatric problems&#xD;
&#xD;
          -  Significant medical comorbidity&#xD;
&#xD;
          -  Body Mass Index (BMI) ≤ 19 and ≥ 40 kg/m2&#xD;
&#xD;
          -  Excessive alcohol consumption&#xD;
&#xD;
          -  Taking high dose nutritional supplements&#xD;
&#xD;
          -  Dietary restrictions/allergies that would substantially limit ability to complete&#xD;
             study requirements&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  History of, or comorbid condition which may alter performance on cognitive tests e.g.&#xD;
             stroke, head injury, Parkinson's disease, learning disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jayne Woodside, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queens University Belfast</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Belfast Health and Social Care Trust</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 1, 2019</last_update_submitted>
  <last_update_submitted_qc>November 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University, Belfast</investigator_affiliation>
    <investigator_full_name>Jayne Woodside, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Mediterranean diet</keyword>
  <keyword>Lifestyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT03265522
org study id: 16/NI/0105
nct id: NCT03265522
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evidence suggests that a Mediterranean diet can have a beneficial effect on brain health.
      Mild cognitive impairment (MCI) describes problems with brain function such as difficulty
      with day-to-day memory and concentration. It is at this stage that Mediterranean diet could
      prove beneficial in terms of prevention.

      Previous research by Queens University investigated the opinions of patients with MCI and
      their care givers to inform the development of Mediterranean diet education material to
      encourage behaviour change. The study suggested that MCI patients lacked awareness of the
      link between Mediterranean diet and brain function, although were interested to learn more.
      Feedback on the developed educational material was positive although there were suggested
      improvements such as tailoring information to memory loss, a potential staged approach to
      delivery and adaptations to the material content.

      This present study aims to pilot test refined educational material among MCI participants to
      evaluate the feasibility of encouraging dietary behaviour change among this patient group.
This study aims to evaluate the feasibility of a theory-based, tailored Mediterranean
      lifestyle education intervention to encourage behaviour change in patients with MCI. The
      proposed study will be a 6 month RCT with a total of 60 MCI patients who will be randomised
      to 1 of 3 groups:

        1. Group 1 will receive the Mediterranean lifestyle education resource on one occasion at
           baseline

        2. Group 2 will receive the Mediterranean lifestyle education resource at monthly intervals
           for 5 months accompanied by telephone feedback from the research dietitian

        3. Group 3 will receive standard care (control group). Participants will receive the
           Mediterranean lifestyle education resource after their final 6 month study visit (i.e.
           delayed intervention).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Mediterranean Diet Score (MDS) at 6 months
time frame: Baseline, 6 months
description: Mediterranean dietary intake will be measured by a validated questionnaire
measure: Physical Activity
time frame: Baseline, 6 months
description: RPAQ-Recent Physical Activity Questionnaire
measure: Anthropometric measurements
time frame: Baseline, 6 months
description: Weight and height measurements to calculate BMI
measure: Muscle Strength
time frame: Baseline, 6 months
description: Measured using a grip-strength dynamometer
measure: Geriatric Depression Scale
time frame: Baseline, 6 months
description: Geriatric Depression Scale Questionnaire
measure: Functional Assessment (1)
time frame: Baseline, 6 months
description: Measured by the instrumental activities of daily living scale (IADL) by Lawton and Brody (1969) questionnaire
measure: Cognitive Assessment
time frame: Baseline, 6 months
description: A comprehensive cognitive assessment will be performed, including: global cognition, motor skills, executive function episodic/visual memory, and information processing and sustained attention using a validated neuropsychological test battery (Cantab Cognitive Battery, Cambridge Cognition Ltd.)
measure: Barriers to consuming a Mediterranean Diet questionnaire
time frame: Baseline, 6 months
description: Dietary behaviour change questionnaire to measure adherence to a Mediterranean diet
measure: Blood Sample
time frame: Baseline, 6 months
description: A blood sample will be taken from participants to be stored for analysis of biomarkers of MD adherence and biomarkers of neurodegenerative disease risk.
measure: Functional Assessment (2)
time frame: Baseline, 6 months
description: Measured by the Bristol activities of daily living scale (Bucks et al. 1996) questionnaire
measure: 4-day Food Diary
time frame: Baseline, 6 months
description: A food diary will be completed to assess compliance with a Mediterranean diet
measure: Change in Lifestyle questionnaire
time frame: Baseline, 6 months
description: A questionnaire to measure change in lifestyle behaviours
measure: Dietary Quality of Life questionnaire
time frame: Baseline, 6 months
description: A questionnaire to measure dietary quality of life
measure: Mediterranean Diet Knowledge questionnaire
time frame: Baseline, 6 months
description: A questionnaire to measure participants Mediterranean diet knowledge
measure: Rand SF-36 HEALTH SURVEY
time frame: Baseline, 6 months
description: A questionnaire to measure participants views and beliefs on health
measure: Staging Algorithm Questionnaire
time frame: Baseline, 6 months
description: A questionnaire to measure participants readiness to change their diet and lifestyle
measure: Mediterranean Diet self-efficacy questionnaire
time frame: Baseline, 6 months
description: A questionnaire to measure participants self-efficacy
measure: Mediterranean diet tolerance questionnaire
time frame: Baseline, 6 months
description: A questionnaire to measure tolerance to a Mediterranean diet
measure: Process Evaluation (1) - telephone contact evaluation
time frame: up to 3 months post intervention
description: Determination individual participation and engagement with the intervention by reviewing telephone contact log record and telephone checklist evaluation
measure: Process Evaluation (2) - study records
time frame: up to 3 months post intervention
description: A review of study records- including attrition rates, reason for dropout
measure: Process Evaluation (3) - structured interviews
time frame: up to 3 months post intervention
description: Post intervention structured interviews for participant evaluation of the intervention programme and dietary educational materials
arm group label: Group 1: "ThinkMed" resource at baseline
arm group type: Experimental
description: The "ThinkMed" resource contains an information booklet, recipe books, menu plan cards, shopping list cards and goal setting cards. Participants will receive this resource on one occasion at baseline (n=20)
arm group label: Group 2: "ThinkMed" resource (staged)
arm group type: Experimental
description: This group of participants will receive the "ThinkMed" resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian (n=20)
arm group label: Group 3: Standard Care (control) group
arm group type: Placebo Comparator
description: Participants will continue with the standard care provided by their physician. Participants will receive the "ThinkMed" resource after their final 6 month study visit (i.e. delayed intervention) (n=20)
intervention type: Behavioral
intervention name: "ThinkMed" resource at baseline
description: The "ThinkMed" resource contains an information booklet, recipe books, menu plan cards, shopping list cards and goal setting cards. Participants will receive this resource on one occasion at baseline.
arm group label: Group 1: "ThinkMed" resource at baseline
intervention type: Behavioral
intervention name: Standard Care Control
description: Participants will continue with the standard care provided by their physician. Participants will receive the "ThinkMed" resource after their final 6 month study visit (i.e. delayed intervention).
arm group label: Group 3: Standard Care (control) group
intervention type: Behavioral
intervention name: "ThinkMed" resource (staged)
description: This group of participants will receive the "ThinkMed" resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian
arm group label: Group 2: "ThinkMed" resource (staged)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jayne Woodside, PhD
role: Principal Investigator
affiliation: Queens University Belfast
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Queen's University, Belfast
investigator full name: Jayne Woodside, PhD
investigator title: Professor
mesh term: Cognitive Dysfunction