<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/NCT03028714</url>
  </required_header>
  <id_info>
    <org_study_id>FREC 2016-04-001</org_study_id>
    <nct_id>NCT03028714</nct_id>
  </id_info>
  <brief_title>The Impact of Online Quiz-games on Nutrition Knowledge and Related Outcomes Among University Students.</brief_title>
  <official_title>The Impact of an Educational Intervention on Nutrition Knowledge, Dietary Habits, BMI and Physical Activity, in University Students in the United Kingdom (UK).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kingston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St George's, University of London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kingston University</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>
      Metabolic risk factors, such as central obesity, increase the risk of chronic diseases in&#xD;
      adulthood and are prevalent in many university students. Increasing the knowledge about&#xD;
      healthy nutrition and physical activity can positively impact students' lifestyle and prevent&#xD;
      weight gain. This study aims to investigate the impact of online educational methods on&#xD;
      nutrition knowledge, dietary habits, BMI, and physical activity in a sample of university&#xD;
      students in the UK. Anthropometric measurements will be assessed and questionnaires will be&#xD;
      completed at the beginning and at the end of the study. Written consent will be sought, the&#xD;
      voluntary nature of participation will be emphasized while anonymity and confidentiality will&#xD;
      be strictly maintained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention is a randomized-controlled trial with two data collection points: one at the&#xD;
      beginning and one at the end of the study. The study will include healthy students from two&#xD;
      UK Universities, who they will be randomly assigned either to the intervention or to the&#xD;
      control group. Participants in both groups will be asked to undertake measurements and&#xD;
      complete questionnaires before and after the study. Measurements include the assessment of&#xD;
      BMI, body fat, lean mass, waist-to-hip ratio, systolic and diastolic blood pressure and blood&#xD;
      glucose. In addition, nutrition knowledge and dietary habits will be estimated using online&#xD;
      questionnaires as well as the level of physical activity using the IPAQ questionnaire and&#xD;
      pedometers. Participants in the intervention group will receive access to an educational&#xD;
      website including information about fruit and vegetables, fat, sugars, fast-food, meat, salt,&#xD;
      meals and snacks, food labels, exercise, and alcohol. Each category will be linked to an&#xD;
      online quiz-game that will include questions related to the topic. Students will be asked to&#xD;
      play the games as much as they want to improve their knowledge scores. Access to the website&#xD;
      and the games will be available for 10 weeks. Participants in the control group will receive&#xD;
      no intervention. After 10 weeks, participants will be asked to undertake the same&#xD;
      measurements and complete the same questionnaires as they did in the beginning of the study.&#xD;
      The study aims to investigate the effectiveness of an online educational intervention, using&#xD;
      game elements, on the level of nutrition knowledge of students, as well as, whether any&#xD;
      changes in knowledge impact changes in dietary habits, physical activity and weight-related&#xD;
      factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 15, 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>Level of nutrition knowledge (score in units)</measure>
    <time_frame>One year</time_frame>
    <description>The level of nutrition knowledge will be assessed using the General Nutrition Knowledge Questionnaire (GNKQ) (Kliemann et al., 2016). The GNKQ includes questions with multiple choice answers, presented in 4 sections: section 1 is related to dietary recommendations, section 2 is related to food groups, section 3 is related to health food choices and section 4 is related to diet, disease and weight association. Each correct answer gets a point (otherwise null) and the maximum score is 88 for the overall questionnaire, 18 for section 1, 36 for section 2, 13 for section 3 and 21 for section 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dietary habits (score in units)</measure>
    <time_frame>One year</time_frame>
    <description>Dietary habits will be assessed using the questionnaire of Leppälä, J. et al. (2010). The questionnaire includes 18 questions in relation to whole grain products, fat containing foods, dairy products, vegetables and fruits, sugar and meal pattern. A scoring system is provided as a manual to calculate the total score based on the answer given to each question. The total score represents diet quality (Index of Diet Quality) and can be ranged from 0-15, with 9 or less points indicating a poor diet quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity [vigorous activity (days/week, minutes/week), moderate activity (days/week, minutes/week), walking (days/week, minutes/week), sitting time (minutes/week)].</measure>
    <time_frame>One year</time_frame>
    <description>Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ-short) (Craig et al., 2003). The questionnaire includes questions regarding 1) days per week and time (minutes) spent on one of those days doing vigorous activity, 2) days per week and time (minutes) spent on one of those days doing moderate activity, 3) days per week and time (minutes) spent on one of those days walking and 4) time (minutes) spent the last week sitting on a week day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity (number of steps/week).</measure>
    <time_frame>One year</time_frame>
    <description>Pedometers will be used to calculate the amount of physical activity by counting daily number of steps.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI) (kg/m2)</measure>
    <time_frame>1 year</time_frame>
    <description>BMI (kg/m2) will be estimated after measuring body weight (kg), using an analog scale and height (in meters), using a stadiometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat (%)</measure>
    <time_frame>1 year</time_frame>
    <description>Body fat (%) will be estimated using a TANITA body fat analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lean mass (kg)</measure>
    <time_frame>1 year</time_frame>
    <description>Lean mass (kg) will be estimated using a TANITA body fat analyzer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist-to-hip ratio (WHR)</measure>
    <time_frame>1 year</time_frame>
    <description>To calculate waist-to-hip ratio a measuring tape will be used to measure waist circumference (cm) and hip circumference (cm) separately. Waist circumference (cm) will be measured at the midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line. Hip circumference (cm) will be measured at the largest circumference of the buttocks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure (mmHg)</measure>
    <time_frame>1 year</time_frame>
    <description>Systolic (mmHg) and diastolic (mmHg) blood pressure will be measured using an electronic sphygmomanometer. The participant will be in a relaxed, quiet room at a comfortable temperature and a short period of 5 minutes rest will precede the measurement.The measurement will be undertaken twice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose (mmol/l)</measure>
    <time_frame>1 year</time_frame>
    <description>Blood glucose levels (mmol/l) will be measured by finger pricking using a blood glucose meter. The participant will be asked to be fasted.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Technology-based nutrition education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive access to a website including educational information about nutrition and related topics. Through the website they will be asked to play online quiz-games relevant to the content of the website to improve their knowledge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group will receive no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Technology-based nutrition education</intervention_name>
    <description>All participants will undertake anthropometric measurements and assessments of blood pressure and blood glucose. They will be also asked to complete online questionnaires with regards to nutrition and physical activity. Participants in the intervention group will receive additional access to a website, providing information about nutrition topics including alcohol and physical activity. Through the website participants will be asked to play online quiz-games related to the nutrition topics. Each play will include game elements such as time, point collection and graphics. Participants will be asked to play the games as much as they want to improve their scores and to use the website as a reference tool.</description>
    <arm_group_label>Technology-based nutrition education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently studying at Kingston University, London or at St George's, University of&#xD;
             London, as an undergraduate or postgraduate student or undertaking research within one&#xD;
             of the two organizations.&#xD;
&#xD;
          -  Aged between 18 and 34 years.&#xD;
&#xD;
          -  Generally, in good health.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not currently studying at Kingston University, London or at St George's, University of&#xD;
             London.&#xD;
&#xD;
          -  Less than 18 or more than 34 years old.&#xD;
&#xD;
          -  Suffering a long-term disease or condition that requires a special treatment or diet.&#xD;
&#xD;
          -  Suffering a mobility impairment or injury that doesn't allow undertaking moderate&#xD;
             physical activity.&#xD;
&#xD;
          -  Pregnant or breast-feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>34 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katerina Belogianni, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kingston University, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kingston University, London &amp; St George's, University of London</name>
      <address>
        <city>London</city>
        <zip>SW17 0RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Kliemann N, Wardle J, Johnson F, Croker H. Reliability and validity of a revised version of the General Nutrition Knowledge Questionnaire. Eur J Clin Nutr. 2016 Oct;70(10):1174-1180. doi: 10.1038/ejcn.2016.87. Epub 2016 Jun 1.</citation>
    <PMID>27245211</PMID>
  </results_reference>
  <results_reference>
    <citation>Leppala J, Lagstrom H, Kaljonen A, Laitinen K. Construction and evaluation of a self-contained index for assessment of diet quality. Scand J Public Health. 2010 Dec;38(8):794-802. doi: 10.1177/1403494810382476. Epub 2010 Sep 16.</citation>
    <PMID>20846997</PMID>
  </results_reference>
  <results_reference>
    <citation>Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.</citation>
    <PMID>12900694</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>August 7, 2018</last_update_submitted>
  <last_update_submitted_qc>August 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kingston University</investigator_affiliation>
    <investigator_full_name>Katerina Belogianni</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>University</keyword>
  <keyword>College</keyword>
  <keyword>University students</keyword>
  <keyword>Health education</keyword>
  <keyword>Educational techonology</keyword>
  <keyword>Internet</keyword>
  <keyword>Nutrition knowledge</keyword>
  <keyword>Eating behaviour</keyword>
  <keyword>Diet</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Weight gain prevention</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03028714
org study id: FREC 2016-04-001
nct id: NCT03028714
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Metabolic risk factors, such as central obesity, increase the risk of chronic diseases in
      adulthood and are prevalent in many university students. Increasing the knowledge about
      healthy nutrition and physical activity can positively impact students' lifestyle and prevent
      weight gain. This study aims to investigate the impact of online educational methods on
      nutrition knowledge, dietary habits, BMI, and physical activity in a sample of university
      students in the UK. Anthropometric measurements will be assessed and questionnaires will be
      completed at the beginning and at the end of the study. Written consent will be sought, the
      voluntary nature of participation will be emphasized while anonymity and confidentiality will
      be strictly maintained.
The intervention is a randomized-controlled trial with two data collection points: one at the
      beginning and one at the end of the study. The study will include healthy students from two
      UK Universities, who they will be randomly assigned either to the intervention or to the
      control group. Participants in both groups will be asked to undertake measurements and
      complete questionnaires before and after the study. Measurements include the assessment of
      BMI, body fat, lean mass, waist-to-hip ratio, systolic and diastolic blood pressure and blood
      glucose. In addition, nutrition knowledge and dietary habits will be estimated using online
      questionnaires as well as the level of physical activity using the IPAQ questionnaire and
      pedometers. Participants in the intervention group will receive access to an educational
      website including information about fruit and vegetables, fat, sugars, fast-food, meat, salt,
      meals and snacks, food labels, exercise, and alcohol. Each category will be linked to an
      online quiz-game that will include questions related to the topic. Students will be asked to
      play the games as much as they want to improve their knowledge scores. Access to the website
      and the games will be available for 10 weeks. Participants in the control group will receive
      no intervention. After 10 weeks, participants will be asked to undertake the same
      measurements and complete the same questionnaires as they did in the beginning of the study.
      The study aims to investigate the effectiveness of an online educational intervention, using
      game elements, on the level of nutrition knowledge of students, as well as, whether any
      changes in knowledge impact changes in dietary habits, physical activity and weight-related
      factors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Level of nutrition knowledge (score in units)
time frame: One year
description: The level of nutrition knowledge will be assessed using the General Nutrition Knowledge Questionnaire (GNKQ) (Kliemann et al., 2016). The GNKQ includes questions with multiple choice answers, presented in 4 sections: section 1 is related to dietary recommendations, section 2 is related to food groups, section 3 is related to health food choices and section 4 is related to diet, disease and weight association. Each correct answer gets a point (otherwise null) and the maximum score is 88 for the overall questionnaire, 18 for section 1, 36 for section 2, 13 for section 3 and 21 for section 4.
measure: Dietary habits (score in units)
time frame: One year
description: Dietary habits will be assessed using the questionnaire of Leppälä, J. et al. (2010). The questionnaire includes 18 questions in relation to whole grain products, fat containing foods, dairy products, vegetables and fruits, sugar and meal pattern. A scoring system is provided as a manual to calculate the total score based on the answer given to each question. The total score represents diet quality (Index of Diet Quality) and can be ranged from 0-15, with 9 or less points indicating a poor diet quality.
measure: Physical activity [vigorous activity (days/week, minutes/week), moderate activity (days/week, minutes/week), walking (days/week, minutes/week), sitting time (minutes/week)].
time frame: One year
description: Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ-short) (Craig et al., 2003). The questionnaire includes questions regarding 1) days per week and time (minutes) spent on one of those days doing vigorous activity, 2) days per week and time (minutes) spent on one of those days doing moderate activity, 3) days per week and time (minutes) spent on one of those days walking and 4) time (minutes) spent the last week sitting on a week day.
measure: Physical activity (number of steps/week).
time frame: One year
description: Pedometers will be used to calculate the amount of physical activity by counting daily number of steps.
measure: Body Mass Index (BMI) (kg/m2)
time frame: 1 year
description: BMI (kg/m2) will be estimated after measuring body weight (kg), using an analog scale and height (in meters), using a stadiometer.
measure: Body fat (%)
time frame: 1 year
description: Body fat (%) will be estimated using a TANITA body fat analyzer.
measure: Lean mass (kg)
time frame: 1 year
description: Lean mass (kg) will be estimated using a TANITA body fat analyzer.
measure: Waist-to-hip ratio (WHR)
time frame: 1 year
description: To calculate waist-to-hip ratio a measuring tape will be used to measure waist circumference (cm) and hip circumference (cm) separately. Waist circumference (cm) will be measured at the midpoint between the top of the iliac crest and the lower margin of the last palpable rib in the mid axillary line. Hip circumference (cm) will be measured at the largest circumference of the buttocks.
measure: Blood pressure (mmHg)
time frame: 1 year
description: Systolic (mmHg) and diastolic (mmHg) blood pressure will be measured using an electronic sphygmomanometer. The participant will be in a relaxed, quiet room at a comfortable temperature and a short period of 5 minutes rest will precede the measurement.The measurement will be undertaken twice.
measure: Blood glucose (mmol/l)
time frame: 1 year
description: Blood glucose levels (mmol/l) will be measured by finger pricking using a blood glucose meter. The participant will be asked to be fasted.
arm group label: Technology-based nutrition education
arm group type: Experimental
description: Participants will receive access to a website including educational information about nutrition and related topics. Through the website they will be asked to play online quiz-games relevant to the content of the website to improve their knowledge.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group will receive no intervention.
intervention type: Behavioral
intervention name: Technology-based nutrition education
description: All participants will undertake anthropometric measurements and assessments of blood pressure and blood glucose. They will be also asked to complete online questionnaires with regards to nutrition and physical activity. Participants in the intervention group will receive additional access to a website, providing information about nutrition topics including alcohol and physical activity. Through the website participants will be asked to play online quiz-games related to the nutrition topics. Each play will include game elements such as time, point collection and graphics. Participants will be asked to play the games as much as they want to improve their scores and to use the website as a reference tool.
arm group label: Technology-based nutrition education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 34 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katerina Belogianni, PhD
role: Principal Investigator
affiliation: Kingston University, London
facility: 
country: United Kingdom
citation: Kliemann N, Wardle J, Johnson F, Croker H. Reliability and validity of a revised version of the General Nutrition Knowledge Questionnaire. Eur J Clin Nutr. 2016 Oct;70(10):1174-1180. doi: 10.1038/ejcn.2016.87. Epub 2016 Jun 1.
PMID: 27245211
citation: Leppala J, Lagstrom H, Kaljonen A, Laitinen K. Construction and evaluation of a self-contained index for assessment of diet quality. Scand J Public Health. 2010 Dec;38(8):794-802. doi: 10.1177/1403494810382476. Epub 2010 Sep 16.
PMID: 20846997
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PMID: 12900694
responsible party type: Principal Investigator
investigator affiliation: Kingston University
investigator full name: Katerina Belogianni
investigator title: Principal Investigator
sharing ipd: Undecided