<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/NCT03295578</url>
  </required_header>
  <id_info>
    <org_study_id>P9663</org_study_id>
    <nct_id>NCT03295578</nct_id>
  </id_info>
  <brief_title>Blood Glucose, Cognition and Wellbeing @ Work</brief_title>
  <official_title>Blood Glucose Monitoring, Cognition, and Wellbeing in Relation to Food Intake @ Work - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TNO</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wageningen University and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jumbo Supermarkten Bv.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Noldus Information Technology B.V.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Google LLC.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>TNO</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled pilot study has as a main aim to investigate the relationship&#xD;
      between glucose and cognition and wellbeing, as well as food intake in an at-work setting.&#xD;
      Additionally, the continuous glucose data collected in the study will be used to investigate&#xD;
      the inter- and intraindividual variability in glucose response to foods/meal in a real-life&#xD;
      setting.&#xD;
&#xD;
      Finally, the study aims to determine if self-monitoring and feedback about food intake and&#xD;
      health stimulate individuals to make healthier choices.&#xD;
&#xD;
      This study will have two groups, the feedback group and the control group. The study will&#xD;
      consist of two self-monitoring periods of two weeks. In between these two self-monitoring&#xD;
      periods, the participants in the feedback group will be given feedback on their measurement&#xD;
      data. The control group will not get any feedback.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many people in the Western world have an unhealthy lifestyle, including an unhealthy dietary&#xD;
      pattern. Numerous approaches have been taken to stimulate people to maintain a more healthy&#xD;
      diet, but results are highly variable across studies and subjects. One explanation for this&#xD;
      is that in many approaches the individuals' specific needs and the context they live and work&#xD;
      in are not sufficiently taken into account. For an approach to be more effective, personal&#xD;
      characteristics need to be taken into account. In other words, the approach needs to be&#xD;
      tailored or personalised. When focussing on personalized nutrition and health in the work&#xD;
      environment, the aspects of health that are included in the study should also be relevant for&#xD;
      the work environment. Three main parameters of interest are selected: (postprandial) blood&#xD;
      glucose levels, cognition and (subjective) wellbeing.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      The primary objective of this pilot study is to investigate the relationship between glucose&#xD;
      and cognition and wellbeing, as well as food intake in an at-work setting.&#xD;
&#xD;
      Secondary objectives are :1) Does self-monitoring and feedback about food intake and health&#xD;
      stimulate individuals to make healthier choices? 2) What are the user experiences of&#xD;
      employees to perform self-monitoring of and receive feedback on, glucose, wellbeing and&#xD;
      cognition in the workplace?&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      This study will be designed as a randomized controlled trial with two groups, the feedback&#xD;
      group and the control group. The study will consist of two self-monitoring periods of two&#xD;
      weeks. In between these two self-monitoring periods, the participants in the feedback group&#xD;
      will be given feedback on their measurement data. The control group will not get any&#xD;
      feedback.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Forty participants, both men and women, will be recruited from the staff at the head-quarters&#xD;
      of Jumbo supermarkets in Veghel. Inclusion criteria are presence at head-quarters for at&#xD;
      least 4 days per week and frequent visitors of the company lunch restaurant. Exclusion&#xD;
      criteria are shift work, diabetic patients, neurological or psychiatric complaints and&#xD;
      specific food-related allergies.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      The intervention consists of standardized meals and personalized feedback. During the first&#xD;
      two-week measurement period study participants will be asked to consume standardized lunches&#xD;
      at work days in the company restaurant. In between the two measurement periods, the feedback&#xD;
      group will receive personalized feedback on their self-measured data (interstitial glucose,&#xD;
      cognition, wellbeing, and food intake). At the end of the second measurement period both the&#xD;
      feedback group and the control group will receive a personalized feedback form, including a&#xD;
      debriefing about the study.&#xD;
&#xD;
      Main study parameters/endpoints:&#xD;
&#xD;
      Primary endpoints are self-monitored daily food intake, glucose levels, cognitive&#xD;
      performance, and wellbeing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">December 22, 2017</completion_date>
  <primary_completion_date type="Actual">November 17, 2017</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>
    <intervention_model_description>Randomized controlled trial with two parallel arms.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants will be assigned to the personalised feedback group or generic feedback group (control) by an independent researcher that is not involved in the study. Assignment will be random and balanced for gender and age. To avoid subjects being aware of the group they are in, both groups will receive some sort of feedback, either generic or personalised. Subjects will be informed that they should not discuss their feedback with other study participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Daily glucose levels</measure>
    <time_frame>Continous (sampled every 15 minutes for a duration of 14 days)</time_frame>
    <description>measured using a continuous glucose monitoring device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily food intake</measure>
    <time_frame>daily registration of food intake during working hours for a duration of 14 days (during both the two week measurement periods)..</time_frame>
    <description>measured using a food intake application</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognition tests</measure>
    <time_frame>twice per day (before and after lunch) at working days for a duration of 14 days, during both the two week measurement periods</time_frame>
    <description>via Smartphone application. Tests include direct recall, free recall &amp; delayed recall.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wellbeing</measure>
    <time_frame>This questionnaire will be administered five times per day; two times in the morning, once five minutes before lunch (before with cognition test), once one hour after lunch (before cognition test) and once in the afternoon for two times 14 days.</time_frame>
    <description>via Smartphone application. Includes VAS scales for including five questions for 'feeling energetic - tired, 'feeling focused - distracted', 'feeling positive - negative' , 'feeling motivated - unmotivated' , 'feeling relaxed - stressed'</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intention to eat healthy</measure>
    <time_frame>baseline and after eight weeks (end of study)</time_frame>
    <description>measured with three items on seven-point scales from totally disagree (1) to totally agree (7). The items are 'I'm planning on eating healthy', 'I would consider to eat healthy' and 'I'm absolutely going to eat healthy'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative user experiences</measure>
    <time_frame>baseline and after eight weeks (end of study)</time_frame>
    <description>Self-efficacy towards maintaining a healthy diet and type of motivation to eat healthy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative user experiences</measure>
    <time_frame>four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks</time_frame>
    <description>the survey includes self-constructed scales that measure user experience with the research in general, self-monitoring devices and personal feedback. Focus groups are needed to understand the reasoning behind the answers that employees give in the surveys and to validate initial analysis of the survey.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Focus on future consequences</measure>
    <time_frame>baseline</time_frame>
    <description>validated questionnaire from Joireman et al (2012). Output will be used as input for formulating the personalized feedback</description>
  </other_outcome>
  <other_outcome>
    <measure>Subjective health</measure>
    <time_frame>Baseline and after eight weeks (end of study)</time_frame>
    <description>• Subjective health is measured with two items that are rated on seven-point scales from 'very unhealthy' (1) to 'very healthy' (7).</description>
  </other_outcome>
  <other_outcome>
    <measure>Eating habits (at the workplace)</measure>
    <time_frame>Baseline and after eight weeks (end of study)</time_frame>
    <description>mapped via a questionnaire, concerning how often one eats breakfast and snacks, how often one eats in the company restaurant at work, how often one brings their own lunch or buys their lunch, how often one goes on lunch walks etc.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical activity</measure>
    <time_frame>Baseline and after eight weeks (end of study)</time_frame>
    <description>the Dutch Norm for Healthy Physical Activity.</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>Baseline and after eight weeks (end of study)</time_frame>
    <description>calculated based on self-reported height and weight</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Healthy</condition>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>Personalized feedback group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In between the two measurement periods, the personalized feedback group will receive an explanation and personalized feedback on their self-measured data (interstitial glucose, cognition, wellbeing and food intake).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General feedback group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The generic feedback group will receive a generic explanation about glucose, cognition wellbeing and food intake and their relationship. The generic feedback will not include personal results.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalized feedback</intervention_name>
    <description>The personalized feedback report will contain a general explanation about glucose, cognition and wellbeing, healthy cut-offs and/or benchmark values, and why these measures are relevant for personal health and wellbeing. Also, a general explanation will be given about how glucose levels can be influenced.&#xD;
Also, the personalized feedback will contain the individual glucose response profiles, as well as graphs showing the wellbeing scores over time. The registered food intake will be mapped and linked to the glucose and wellbeing profiles. The results of the wellbeing questionnaire will also be shown and will be linked to the individual profiles and food intake.</description>
    <arm_group_label>Personalized feedback group</arm_group_label>
    <other_name>personalized feedback report</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Generic feedback</intervention_name>
    <description>The generic feedback will contain a generic explanation about glucose, cognition wellbeing and food intake and their relationship. The generic feedback will not include personal results.</description>
    <arm_group_label>General feedback group</arm_group_label>
    <other_name>Generic feedback report</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous glucose monitoring device</intervention_name>
    <description>This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.</description>
    <arm_group_label>General feedback group</arm_group_label>
    <arm_group_label>Personalized feedback group</arm_group_label>
    <other_name>Abbott FreeStyle Libre Pro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be present at Jumbo head-quarters during lunch at least four days/week and have&#xD;
             access to their computer for one hour after lunch during the two 2-week&#xD;
             self-monitoring periods&#xD;
&#xD;
          -  Must be frequent visitors of the company lunch restaurant (Jumbo food café), with a&#xD;
             minimum of three times per week&#xD;
&#xD;
          -  Having giving written informed consent&#xD;
&#xD;
          -  Willing to comply with all study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Shift workers&#xD;
&#xD;
          -  Diabetes type 2 patients&#xD;
&#xD;
          -  Under treatment for neurological or psychiatric complaints, including eating disorders&#xD;
&#xD;
          -  Specific dietary preferences, including vegan, raw food, paleo. Vegetarian,&#xD;
             pescetarians and flexitarians can participate in the study&#xD;
&#xD;
          -  Allergies or intolerances, including coeliac disease, gluten intolerance, lactose&#xD;
             intolerance, milk protein allergy&#xD;
&#xD;
          -  Skin allergy or eczema&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iris M de Hoogh, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>TNO (Netherlands Organization for Applied Scientific Research)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jumbo Supermarkten BV.</name>
      <address>
        <city>Veghel</city>
        <state>Noord-Brabant</state>
        <zip>5462 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>TNO</investigator_affiliation>
    <investigator_full_name>Iris de Hoogh</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <keyword>employees</keyword>
  <keyword>continuous glucose monitoring</keyword>
  <keyword>personalized feedback</keyword>
  <keyword>cognition</keyword>
  <keyword>wellbeing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03295578
org study id: P9663
nct id: NCT03295578
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This randomized controlled pilot study has as a main aim to investigate the relationship
      between glucose and cognition and wellbeing, as well as food intake in an at-work setting.
      Additionally, the continuous glucose data collected in the study will be used to investigate
      the inter- and intraindividual variability in glucose response to foods/meal in a real-life
      setting.

      Finally, the study aims to determine if self-monitoring and feedback about food intake and
      health stimulate individuals to make healthier choices.

      This study will have two groups, the feedback group and the control group. The study will
      consist of two self-monitoring periods of two weeks. In between these two self-monitoring
      periods, the participants in the feedback group will be given feedback on their measurement
      data. The control group will not get any feedback.
Many people in the Western world have an unhealthy lifestyle, including an unhealthy dietary
      pattern. Numerous approaches have been taken to stimulate people to maintain a more healthy
      diet, but results are highly variable across studies and subjects. One explanation for this
      is that in many approaches the individuals' specific needs and the context they live and work
      in are not sufficiently taken into account. For an approach to be more effective, personal
      characteristics need to be taken into account. In other words, the approach needs to be
      tailored or personalised. When focussing on personalized nutrition and health in the work
      environment, the aspects of health that are included in the study should also be relevant for
      the work environment. Three main parameters of interest are selected: (postprandial) blood
      glucose levels, cognition and (subjective) wellbeing.

      Objective:

      The primary objective of this pilot study is to investigate the relationship between glucose
      and cognition and wellbeing, as well as food intake in an at-work setting.

      Secondary objectives are :1) Does self-monitoring and feedback about food intake and health
      stimulate individuals to make healthier choices? 2) What are the user experiences of
      employees to perform self-monitoring of and receive feedback on, glucose, wellbeing and
      cognition in the workplace?

      Study design:

      This study will be designed as a randomized controlled trial with two groups, the feedback
      group and the control group. The study will consist of two self-monitoring periods of two
      weeks. In between these two self-monitoring periods, the participants in the feedback group
      will be given feedback on their measurement data. The control group will not get any
      feedback.

      Study population:

      Forty participants, both men and women, will be recruited from the staff at the head-quarters
      of Jumbo supermarkets in Veghel. Inclusion criteria are presence at head-quarters for at
      least 4 days per week and frequent visitors of the company lunch restaurant. Exclusion
      criteria are shift work, diabetic patients, neurological or psychiatric complaints and
      specific food-related allergies.

      Intervention:

      The intervention consists of standardized meals and personalized feedback. During the first
      two-week measurement period study participants will be asked to consume standardized lunches
      at work days in the company restaurant. In between the two measurement periods, the feedback
      group will receive personalized feedback on their self-measured data (interstitial glucose,
      cognition, wellbeing, and food intake). At the end of the second measurement period both the
      feedback group and the control group will receive a personalized feedback form, including a
      debriefing about the study.

      Main study parameters/endpoints:

      Primary endpoints are self-monitored daily food intake, glucose levels, cognitive
      performance, and wellbeing.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial with two parallel arms.
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Participants will be assigned to the personalised feedback group or generic feedback group (control) by an independent researcher that is not involved in the study. Assignment will be random and balanced for gender and age. To avoid subjects being aware of the group they are in, both groups will receive some sort of feedback, either generic or personalised. Subjects will be informed that they should not discuss their feedback with other study participants.
measure: Daily glucose levels
time frame: Continous (sampled every 15 minutes for a duration of 14 days)
description: measured using a continuous glucose monitoring device
measure: Daily food intake
time frame: daily registration of food intake during working hours for a duration of 14 days (during both the two week measurement periods)..
description: measured using a food intake application
measure: Cognition tests
time frame: twice per day (before and after lunch) at working days for a duration of 14 days, during both the two week measurement periods
description: via Smartphone application. Tests include direct recall, free recall & delayed recall.
measure: Wellbeing
time frame: This questionnaire will be administered five times per day; two times in the morning, once five minutes before lunch (before with cognition test), once one hour after lunch (before cognition test) and once in the afternoon for two times 14 days.
description: via Smartphone application. Includes VAS scales for including five questions for 'feeling energetic - tired, 'feeling focused - distracted', 'feeling positive - negative' , 'feeling motivated - unmotivated' , 'feeling relaxed - stressed'
measure: Intention to eat healthy
time frame: baseline and after eight weeks (end of study)
description: measured with three items on seven-point scales from totally disagree (1) to totally agree (7). The items are 'I'm planning on eating healthy', 'I would consider to eat healthy' and 'I'm absolutely going to eat healthy'.
measure: Quantitative user experiences
time frame: baseline and after eight weeks (end of study)
description: Self-efficacy towards maintaining a healthy diet and type of motivation to eat healthy
measure: Qualitative user experiences
time frame: four short surveys (baseline, day 1, after two weeks, after eight weeks) and in focus groups after eight weeks
description: the survey includes self-constructed scales that measure user experience with the research in general, self-monitoring devices and personal feedback. Focus groups are needed to understand the reasoning behind the answers that employees give in the surveys and to validate initial analysis of the survey.
measure: Focus on future consequences
time frame: baseline
description: validated questionnaire from Joireman et al (2012). Output will be used as input for formulating the personalized feedback
measure: Subjective health
time frame: Baseline and after eight weeks (end of study)
description: • Subjective health is measured with two items that are rated on seven-point scales from 'very unhealthy' (1) to 'very healthy' (7).
measure: Eating habits (at the workplace)
time frame: Baseline and after eight weeks (end of study)
description: mapped via a questionnaire, concerning how often one eats breakfast and snacks, how often one eats in the company restaurant at work, how often one brings their own lunch or buys their lunch, how often one goes on lunch walks etc.
measure: Physical activity
time frame: Baseline and after eight weeks (end of study)
description: the Dutch Norm for Healthy Physical Activity.
measure: BMI
time frame: Baseline and after eight weeks (end of study)
description: calculated based on self-reported height and weight
arm group label: Personalized feedback group
arm group type: Experimental
description: In between the two measurement periods, the personalized feedback group will receive an explanation and personalized feedback on their self-measured data (interstitial glucose, cognition, wellbeing and food intake).
arm group label: General feedback group
arm group type: Placebo Comparator
description: The generic feedback group will receive a generic explanation about glucose, cognition wellbeing and food intake and their relationship. The generic feedback will not include personal results.
intervention type: Other
intervention name: Personalized feedback
description: The personalized feedback report will contain a general explanation about glucose, cognition and wellbeing, healthy cut-offs and/or benchmark values, and why these measures are relevant for personal health and wellbeing. Also, a general explanation will be given about how glucose levels can be influenced.
Also, the personalized feedback will contain the individual glucose response profiles, as well as graphs showing the wellbeing scores over time. The registered food intake will be mapped and linked to the glucose and wellbeing profiles. The results of the wellbeing questionnaire will also be shown and will be linked to the individual profiles and food intake.
arm group label: Personalized feedback group
other name: personalized feedback report
intervention type: Other
intervention name: Generic feedback
description: The generic feedback will contain a generic explanation about glucose, cognition wellbeing and food intake and their relationship. The generic feedback will not include personal results.
arm group label: General feedback group
other name: Generic feedback report
intervention type: Device
intervention name: Continuous glucose monitoring device
description: This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.
arm group label: General feedback group
arm group label: Personalized feedback group
other name: Abbott FreeStyle Libre Pro
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Iris M de Hoogh, Msc
role: Principal Investigator
affiliation: TNO (Netherlands Organization for Applied Scientific Research)
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: TNO
investigator full name: Iris de Hoogh
investigator title: Research Scientist
mesh term: Prediabetic State
sharing ipd: No