<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/NCT03244150</url>
  </required_header>
  <id_info>
    <org_study_id>09-060078/FSS</org_study_id>
    <secondary_id>2003-0200-13</secondary_id>
    <nct_id>NCT03244150</nct_id>
  </id_info>
  <brief_title>Youth and Sport Study</brief_title>
  <acronym>YSS</acronym>
  <official_title>Youth and Sport Study - a 20 Year Follow-up Study of Danish Teenagers Born Between 1964 and 1969</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>the Danish Medical Research Council (grant number 09-060078/FSS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Danish Ministry of Health (2003-0200-13)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aase and Ejnar Danielsens Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Copenhagen Hospital Corporation (now Copenhagen Capital Region)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bispebjerg Hospital</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 Youth and Sport Study (YSS) is a 20-22-year follow-up study of Danish teenagers born&#xD;
      between 1964 and 1969. Baseline data originate from two different studies carried out in 1983&#xD;
      and 1985, and the follow-up study was carried out in 2005.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first baseline study was conducted in 1983 and included 1260 students in high school or&#xD;
      trade school. The questionnaire was designed with focus on various aspects of sports and&#xD;
      physical activity beside more general questions on family, socioeconomic status, height,&#xD;
      weight, alcohol intake, smoking, etc. Furthermore, the participants were subjected to a set&#xD;
      of physical tests and measurements.&#xD;
&#xD;
      The second baseline study was conducted in 1985 and included a representative sample of 2498&#xD;
      teenagers drawn from the Danish Civil Registration (CPR) and invited to participate in the&#xD;
      study with the aim of validating the results from the first baseline sample. The study&#xD;
      consisted of a questionnaire with virtually the same questions as the questionnaire from&#xD;
      1983. A short 28-item food frequency questionnaire (FFQ) was added to the questionnaire, as&#xD;
      well as a few questions about dietary habits.&#xD;
&#xD;
      The follow-up study was carried out in 2005, when the subjects had reached an age of around&#xD;
      40 years. A total of 1904 subjects were traced and asked to complete a general questionnaire,&#xD;
      a food frequency questionnaire, and deliver a DNA sample, all distributed and returned&#xD;
      through mail correspondence. The general questionnaire included questions on education,&#xD;
      occupation, height, previous and present weight, weight loss history, physical activity,&#xD;
      smoking, civil status, children, other family, stress, diseases, hospital admissions, and&#xD;
      medicine use, among other things. The questions about physical activity were adopted from the&#xD;
      baseline questionnaire. Other questions were adopted from other validated questionnaires.&#xD;
      Moreover, a semi-quantitative, 195-item Food Frequency Questionnaire (FFQ), which previously&#xD;
      has been used and validated in the Danish &quot;Diet, Cancer and Health&quot; study was included. The&#xD;
      study was approved by the local ethics committee for Copenhagen and Frederiksberg (J.nr. KF&#xD;
      01-260/04).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 1983</start_date>
  <completion_date type="Actual">August 1, 2005</completion_date>
  <primary_completion_date type="Actual">August 1, 2005</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Collected/measured in 1983 or 1985 and at follow-up in 2005</time_frame>
    <description>Leisure time physical activity has been assessed by questionnaire, where participants filled in the different types of sports they attended and the time they actively participated in each type of sport per week. Lastly, the type and the amount of time spend on activities outside of school and sports clubs were also assessed. Each sport and activity has been translated into metabolic equivalent (MET) scores [28]. MET scores at the individual time points and changes during follow-up will be used as outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>Weight was reported in 1983 or 1985 and at follow-up in 2005</time_frame>
    <description>BMI will be calculated using self-reported height and weight for both baseline and follow-up surveys. BMI at the individual time points and changes during follow-up will be used as outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Waist circumference was at follow-up in 2005</time_frame>
    <description>Waist circumference was self-reported at the follow-up survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol consumption</measure>
    <time_frame>Alcohol consumption was reported in 1983 or 1985 and at follow-up in 2005</time_frame>
    <description>Alcohol consumption was assessed by the question &quot;How often do you drink different types of alcohol?&quot; with three choices - beer, wine and spirit&quot;. Alcohol at the individual time points and changes during follow-up will be used as outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking</measure>
    <time_frame>Information on smoking was reported in 1983 or 1985 and at follow-up in 2005</time_frame>
    <description>Smoking was assessed with the questions on smoking status and amount of tobacco smoked at baseline and follow-up. Information on smoking at the individual time points and changes during follow-up will be used as outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Education and occupation</measure>
    <time_frame>Information on education and occupation was reported in 2005</time_frame>
    <description>At follow-up, participants were asked to report their occupation and highest achieved education.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental education and occupation</measure>
    <time_frame>Information on education and occupation was reported in 1983 or 1985</time_frame>
    <description>At baseline, participants were asked to report parental occupation and highest education.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Macronutrient intake</measure>
    <time_frame>Information on macronutrient intake was reported in 2005</time_frame>
    <description>At follow-up, participants completed a 28-item food frequency questionnaire. From this we will calculate the participants' macronutrient intake.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3008</enrollment>
  <condition>Physical Activity</condition>
  <condition>Obesity</condition>
  <condition>Lifestyle</condition>
  <arm_group>
    <arm_group_label>School sample</arm_group_label>
    <description>Conducted in 1983 and included 1260 students in high school or trade school.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nationwide sample</arm_group_label>
    <description>Conducted in 1985 and included a representative sample of 2498 teenagers drawn from the Danish Civil Registration (CPR)</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      DNA samples were collected by cheek scrapings, which were distributed and returned through&#xD;
      mail.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The first baseline study included 1260 students in gymnasium, vocational school, or trade&#xD;
        school born in 1964-68.&#xD;
&#xD;
        The second baseline study included a representative sample of 2498 teenagers born in 1967&#xD;
        or 1969 (1.5% of the total population).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Danish teenagers born between 1964 and 1969.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Parker Institute</name>
      <address>
        <city>Frederiksberg</city>
        <zip>2000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Berit Lilienthal Heitmann</investigator_full_name>
    <investigator_title>Professor, Ph.D</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Obesity</keyword>
  <keyword>Overweight</keyword>
  <keyword>Lifestyle</keyword>
  <keyword>Diet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT03244150
org study id: 09-060078/FSS
secondary id: 2003-0200-13
nct id: NCT03244150
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Youth and Sport Study (YSS) is a 20-22-year follow-up study of Danish teenagers born
      between 1964 and 1969. Baseline data originate from two different studies carried out in 1983
      and 1985, and the follow-up study was carried out in 2005.
The first baseline study was conducted in 1983 and included 1260 students in high school or
      trade school. The questionnaire was designed with focus on various aspects of sports and
      physical activity beside more general questions on family, socioeconomic status, height,
      weight, alcohol intake, smoking, etc. Furthermore, the participants were subjected to a set
      of physical tests and measurements.

      The second baseline study was conducted in 1985 and included a representative sample of 2498
      teenagers drawn from the Danish Civil Registration (CPR) and invited to participate in the
      study with the aim of validating the results from the first baseline sample. The study
      consisted of a questionnaire with virtually the same questions as the questionnaire from
      1983. A short 28-item food frequency questionnaire (FFQ) was added to the questionnaire, as
      well as a few questions about dietary habits.

      The follow-up study was carried out in 2005, when the subjects had reached an age of around
      40 years. A total of 1904 subjects were traced and asked to complete a general questionnaire,
      a food frequency questionnaire, and deliver a DNA sample, all distributed and returned
      through mail correspondence. The general questionnaire included questions on education,
      occupation, height, previous and present weight, weight loss history, physical activity,
      smoking, civil status, children, other family, stress, diseases, hospital admissions, and
      medicine use, among other things. The questions about physical activity were adopted from the
      baseline questionnaire. Other questions were adopted from other validated questionnaires.
      Moreover, a semi-quantitative, 195-item Food Frequency Questionnaire (FFQ), which previously
      has been used and validated in the Danish "Diet, Cancer and Health" study was included. The
      study was approved by the local ethics committee for Copenhagen and Frederiksberg (J.nr. KF
      01-260/04).
observational model: Cohort
time perspective: Prospective
measure: Physical activity
time frame: Collected/measured in 1983 or 1985 and at follow-up in 2005
description: Leisure time physical activity has been assessed by questionnaire, where participants filled in the different types of sports they attended and the time they actively participated in each type of sport per week. Lastly, the type and the amount of time spend on activities outside of school and sports clubs were also assessed. Each sport and activity has been translated into metabolic equivalent (MET) scores [28]. MET scores at the individual time points and changes during follow-up will be used as outcome.
measure: Body Mass Index (BMI)
time frame: Weight was reported in 1983 or 1985 and at follow-up in 2005
description: BMI will be calculated using self-reported height and weight for both baseline and follow-up surveys. BMI at the individual time points and changes during follow-up will be used as outcome.
measure: Waist circumference
time frame: Waist circumference was at follow-up in 2005
description: Waist circumference was self-reported at the follow-up survey.
measure: Alcohol consumption
time frame: Alcohol consumption was reported in 1983 or 1985 and at follow-up in 2005
description: Alcohol consumption was assessed by the question "How often do you drink different types of alcohol?" with three choices - beer, wine and spirit". Alcohol at the individual time points and changes during follow-up will be used as outcome.
measure: Smoking
time frame: Information on smoking was reported in 1983 or 1985 and at follow-up in 2005
description: Smoking was assessed with the questions on smoking status and amount of tobacco smoked at baseline and follow-up. Information on smoking at the individual time points and changes during follow-up will be used as outcome.
measure: Education and occupation
time frame: Information on education and occupation was reported in 2005
description: At follow-up, participants were asked to report their occupation and highest achieved education.
measure: Parental education and occupation
time frame: Information on education and occupation was reported in 1983 or 1985
description: At baseline, participants were asked to report parental occupation and highest education.
measure: Macronutrient intake
time frame: Information on macronutrient intake was reported in 2005
description: At follow-up, participants completed a 28-item food frequency questionnaire. From this we will calculate the participants' macronutrient intake.
arm group label: School sample
description: Conducted in 1983 and included 1260 students in high school or trade school.
arm group label: Nationwide sample
description: Conducted in 1985 and included a representative sample of 2498 teenagers drawn from the Danish Civil Registration (CPR)
DNA samples were collected by cheek scrapings, which were distributed and returned through
      mail.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 19 Years
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Berit Lilienthal Heitmann
investigator title: Professor, Ph.D
mesh term: Obesity
sharing ipd: No