<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/NCT02224248</url>
  </required_header>
  <id_info>
    <org_study_id>1-15-1-72-13-09</org_study_id>
    <nct_id>NCT02224248</nct_id>
  </id_info>
  <brief_title>Effect of Including Fitness Testing in Preventive Health Checks on Cardiorespiratory Fitness and Motivation</brief_title>
  <official_title>The Effect of Including Fitness Testing in Preventive Health Checks on Cardiorespiratory Fitness and Motivation to Change Physical Activity Behaviour</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Randers Municipality, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Denmark Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>TRYG Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate if including fitness testing in preventive health&#xD;
      checks increase cardiorespiratory fitness and motivation to change physical activity behavior&#xD;
      compared with preventive health checks without fitness testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND&#xD;
&#xD;
      Changing unhealthy lifestyle improves health and reduces morbidity. Motivation is a key&#xD;
      component in initiation and maintenance of lifestyle changes. Identifying and motivating&#xD;
      individuals with unhealthy lifestyle to change behaviour may be achieved through preventive&#xD;
      health checks as already implemented in some countries. However, knowledge about the impact&#xD;
      of individual components included in preventive health checks is lacking. Consequently, the&#xD;
      most effective composition of preventive health checks remains unknown.&#xD;
&#xD;
      In a Danish municipality, the Check your Health Prevention Program (CHPP) was recently&#xD;
      initiated, offering preventive health checks to all 30 to 49 year-old citizens. This program&#xD;
      provides the unique opportunity to evaluate single components of a preventive health check in&#xD;
      a real-life setting. Only a few previous studies have included cardiorespiratory fitness&#xD;
      (fitness) testing in a preventive health check. Fitness is associated with multiple health&#xD;
      benefits such as improved cardio-metabolic profile and reduced risk of cancer, diabetes, and&#xD;
      depression.&#xD;
&#xD;
      The investigators aim to investigate the effect of including fitness testing in preventive&#xD;
      health checks on fitness level, motivation for changing physical activity behaviour, physical&#xD;
      inactivity prevalence and self-rated health. The investigators hypothesize that fitness&#xD;
      testing as part of preventive health checks compared to preventive health checks without&#xD;
      fitness testing 1) increases fitness level assessed after one year and the percentage of&#xD;
      participants increasing motivation to change physical activity behaviour assessed after two&#xD;
      weeks, and 2) reduces physical inactivity prevalence and improves self-rated health scores&#xD;
      during the one-year study period.&#xD;
&#xD;
      METHODS&#xD;
&#xD;
      Nested-design&#xD;
&#xD;
      The present trial is embedded in the above mentioned health promotion program, CHPP, which is&#xD;
      conducted during the years 2012 to 2017. In the CHPP, all citizens living in the municipality&#xD;
      of Randers aged 30-49 years per 1st of January 2012 (n = 26,216) were identified in the&#xD;
      Danish Civil Registration System.The identified population was randomized into five equal&#xD;
      groups, one for each year of the CHPP. Invitations are dispatched continuously by mail and&#xD;
      include information about the CHPP and a prefixed appointment for a health check. Health&#xD;
      checks and health behavioural courses will take place at Randers Health Centre and health&#xD;
      consultations at the citizen´s general practitioner.&#xD;
&#xD;
      The health check&#xD;
&#xD;
      Besides the addition of fitness testing in the intervention group, the preventive health&#xD;
      checks will include assessments of the following: body weight and height, waist&#xD;
      circumference, blood pressure, lipid profile (total cholesterol, LDL, HDL, and&#xD;
      triglycerides), HbA1c and lung function. Moreover, a baseline questionnaire regarding&#xD;
      physical activity level, motivation for changing physical activity behaviour, self-rated&#xD;
      health, smoking, and alcohol will be answered in connection with the health check. At the end&#xD;
      of the health check, the results are presented in a personalized health profile leaflet,&#xD;
      which includes recommendations for follow-up according to the risk-profile. The baseline&#xD;
      questionnaire and the subsequent follow-up procedures are identical in the two study groups.&#xD;
&#xD;
      Standardization and education&#xD;
&#xD;
      The health check will be conducted by health professionals who have been trained in all&#xD;
      measurement procedures as well as in risk communication to ensure standardization and&#xD;
      quality. Execution of the health check is further standardized by a written protocol and&#xD;
      adherence to the protocol is checked continuously. Furthermore, a process evaluation will be&#xD;
      conducted.&#xD;
&#xD;
      Outcome assessment&#xD;
&#xD;
      Cardiorespiratory fitness will be assessed by submaximal cycle ergometer testing. Motivation&#xD;
      for changing physical activity behavior will be assessed using the Transtheoretical Model´s&#xD;
      Stages of Change, and secondary outcomes using a modified version of the questions developed&#xD;
      by Saltin and Grimby and the Short-Form 12, Health Survey, version 2.&#xD;
&#xD;
      Follow up&#xD;
&#xD;
      All participants will receive a questionnaire regarding motivation for changing physical&#xD;
      activity behaviour two weeks after the health check and will be invited for fitness testing&#xD;
      after one year.&#xD;
&#xD;
      Randomization and blinding&#xD;
&#xD;
      Randomization is handled by a data-manager with no scientific involvement. The eligible&#xD;
      population for this trial was defined by the CHPP randomization. Citizens randomized for the&#xD;
      third out of five years of the CHPP will be further randomized by household to either&#xD;
      intervention or control in the present trial. The intervention, the outcomes, group&#xD;
      assignment, and the future outcome assessments in this trial are unrevealed in the invitation&#xD;
      for the CHPP. The health behavioural courses and the health consultations will be carried out&#xD;
      un-blinded due to the real-life setting. At the one-year follow-up, the personnel assessing&#xD;
      the outcomes will be independent and blinded to group allocation.&#xD;
&#xD;
      Sample size&#xD;
&#xD;
      An estimated sample size of 1,500 participants allows for a categorical analysis of fitness&#xD;
      level and is calculated on the basis of the following assumptions: 1:1 randomization, false&#xD;
      positive error rate of 0.05, power of 0.8, intracluster correlation coefficient of 0.05 and&#xD;
      categorical analysis with a power to detect a difference of 10% in the prevalence of very low&#xD;
      fitness between the study groups. The investigators determined this 10% difference to be&#xD;
      clinically meaningful based on expert opinions and criteria employed in other research. The&#xD;
      intracluster correlation coefficient was included to reflect a possible clustering effect of&#xD;
      the general practitioners (n = 46), which is seldom greater than 0.05 in primary care&#xD;
      settings. The estimated sample size accounts for a 30% loss to follow-up.&#xD;
&#xD;
      Statistics&#xD;
&#xD;
      Statistical analysis will be performed using STATA 12.0 software. Continuous variables are&#xD;
      presented as mean ±standard deviation and categorical variables as absolute numbers and&#xD;
      relative (%) frequencies. In the comparative analyses Student´s t-test will be used, when&#xD;
      comparing means or changes in means of continuous variables and Chi2-test or Fisher's exact&#xD;
      t-test, when comparing proportions for categorical variables. Analyses will be adjusted for&#xD;
      baseline physical activity. Stratified analyses will be performed on sex and age groups and&#xD;
      analysis of motivation will only be performed on the subgroup comprising precontemplaters,&#xD;
      contemplaters, and preparators at baseline. All analyses will follow the intention-to-treat&#xD;
      principle. If appropriate, multiple imputation methods will be applied (using data from&#xD;
      social and medical national registries coupled with health check data), and sensitivity&#xD;
      analyses will be performed. Moreover, the potential effect of clustering by the general&#xD;
      practitioners will be investigated. The statistical significance level is set at p &lt; 0.05.&#xD;
&#xD;
      ETHICS AND LEGAL ASPECTS&#xD;
&#xD;
      The trial will comply with The Declaration of Helsinki and each participant will provide&#xD;
      written informed consent for data to be used for research purposes in agreement with the&#xD;
      Danish Health Law. Approval by The Danish Data Protection Agency is obtained (2013-41-2527).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Cardiorespiratory fitness</measure>
    <time_frame>One-year follow up</time_frame>
    <description>Mean cardiorespiratory fitness level and the percentage of participants with very low cardiorespiratory fitness level assessed at the one year follow up will be compared between the two study groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reported physical inactivity prevalence change</measure>
    <time_frame>Between baseline and the one-year follow up.</time_frame>
    <description>Change in reported physical inactivity prevalence from baseline to one-year follow up will be compared between the two study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated general health change</measure>
    <time_frame>From baseline to the one-year follow up.</time_frame>
    <description>Change in self-rated general health from baseline to the one-year follow up will be compared between the two study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated physical health score change</measure>
    <time_frame>From baseline to the one-year follow up.</time_frame>
    <description>Change in self-rated physical health scores from baseline to the one-year follow up will be compared between the two study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated mental health score change</measure>
    <time_frame>From baseline to the one-year follow up.</time_frame>
    <description>Change in self-rated mental health scores from baseline to the one-year follow up will be compared between the two study groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stages of Change for physical activity</measure>
    <time_frame>From baseline to an intermediate two-weeks follow up.</time_frame>
    <description>Stages of Change will be assessed at baseline and two weeks after the health check. Transitions in Stages of Change will be compared between study groups.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2201</enrollment>
  <condition>Cardiorespiratory Fitness</condition>
  <condition>Physical Activity</condition>
  <condition>Health Behavior</condition>
  <condition>Motivation</condition>
  <condition>Intention</condition>
  <arm_group>
    <arm_group_label>Health checks with fitness testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Health checks without fitness testing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health checks with fitness testing</intervention_name>
    <description>Fitness testing as part of a preventive health check compose the intervention in this trial. Thus, the intervention group will receive preventive health checks with fitness testing.</description>
    <arm_group_label>Health checks with fitness testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health checks without fitness testing</intervention_name>
    <description>The active comparator will not receive fitness testing as part of the preventive health checks. With the exception of fitness testing, the preventive health checks in the active comparator group and the intervention group are identical.</description>
    <arm_group_label>Health checks without fitness testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Citizens in the municipality of Randers per 01.01.2012&#xD;
&#xD;
          -  Randomized for the third group of five to be invited for a preventive health check as&#xD;
             part of the health promotion program, Check your health prevention program, conducted&#xD;
             in the years 2012 to 2017.&#xD;
&#xD;
          -  Having received a preventive health check before November 30 2015.&#xD;
&#xD;
          -  Having consented for data to be used scientifically.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Terminal illness as reported by the citizens general practitioner.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annelli Sandbæk, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of public health, section of general practice, Aarhus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of public health, section of general practice, Aarhus University</name>
      <address>
        <city>Aarhus C</city>
        <state>Aarhus county</state>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://apps.who.int/iris/bitstream/10665/94384/1/9789241506236_eng.pdf?ua=1.</url>
    <description>World Health Organization. Global action plan for the prevention and control of noncommunicable diseases 2013-2020</description>
  </link>
  <reference>
    <citation>DISHMAN R, ICKES W, MORGAN W. Self-motivation and adherence to habitual physical-activity. J Appl Soc Psychol. 1980;10(2):115-132. doi: 10.1111/j.1559-1816.1980.tb00697.x.</citation>
  </reference>
  <reference>
    <citation>Dalton AR, Soljak M. The nationwide systematic prevention of cardiovascular disease: the UK's health check programme. J Ambul Care Manage. 2012 Jul-Sep;35(3):206-15. doi: 10.1097/JAC.0b013e318240be9d.</citation>
    <PMID>22668610</PMID>
  </reference>
  <reference>
    <citation>Lauritzen T, Jensen MS, Thomsen JL, Christensen B, Engberg M. Health tests and health consultations reduced cardiovascular risk without psychological strain, increased healthcare utilization or increased costs. An overview of the results from a 5-year randomized trial in primary care. The Ebeltoft Health Promotion Project (EHPP). Scand J Public Health. 2008 Aug;36(6):650-61. doi: 10.1177/1403494807090165.</citation>
    <PMID>18775821</PMID>
  </reference>
  <reference>
    <citation>Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.</citation>
    <PMID>16534088</PMID>
  </reference>
  <reference>
    <citation>Textbook of work physiology. Åstrand &amp; Rodahl. 3rd ed. McGraw Hill 1986.</citation>
  </reference>
  <reference>
    <citation>Nigg CR. There is more to stages of exercise than just exercise. Exerc Sport Sci Rev. 2005 Jan;33(1):32-5.</citation>
    <PMID>15640718</PMID>
  </reference>
  <reference>
    <citation>Saltin B, Grimby G. Physiological analysis of middle-aged and old former athletes. Comparison with still active athletes of the same ages. Circulation. 1968 Dec;38(6):1104-15. doi: 10.1161/01.cir.38.6.1104. No abstract available.</citation>
    <PMID>5721960</PMID>
  </reference>
  <reference>
    <citation>Ware JE, Kosinski M, Turner-Bowker DM, Gandeck B, eds. User∩s manual for the SF-12v2TM health survey (with a supplement documenting the SF-12 health survey). Lincoln, RI: QualityMetric Incorporated, 2007; 2007.</citation>
  </reference>
  <reference>
    <citation>Waters L, Reeves M, Fjeldsoe B, Eakin E. Control group improvements in physical activity intervention trials and possible explanatory factors: a systematic review. J Phys Act Health. 2012 Aug;9(6):884-95. doi: 10.1123/jpah.9.6.884.</citation>
    <PMID>22898467</PMID>
  </reference>
  <reference>
    <citation>Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004 Aug;57(8):785-94. doi: 10.1016/j.jclinepi.2003.12.013.</citation>
    <PMID>15485730</PMID>
  </reference>
  <reference>
    <citation>Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009 Jun 29;338:b2393. doi: 10.1136/bmj.b2393.</citation>
    <PMID>19564179</PMID>
  </reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>November 10, 2016</last_update_submitted>
  <last_update_submitted_qc>November 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiorespiratory fitness</keyword>
  <keyword>exercise tolerance</keyword>
  <keyword>exercise test</keyword>
  <keyword>health behavior</keyword>
  <keyword>motor activity</keyword>
  <keyword>motivation</keyword>
  <keyword>intention</keyword>
  <keyword>self-rated health</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224248
org study id: 1-15-1-72-13-09
nct id: NCT02224248
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to investigate if including fitness testing in preventive health
      checks increase cardiorespiratory fitness and motivation to change physical activity behavior
      compared with preventive health checks without fitness testing.
BACKGROUND

      Changing unhealthy lifestyle improves health and reduces morbidity. Motivation is a key
      component in initiation and maintenance of lifestyle changes. Identifying and motivating
      individuals with unhealthy lifestyle to change behaviour may be achieved through preventive
      health checks as already implemented in some countries. However, knowledge about the impact
      of individual components included in preventive health checks is lacking. Consequently, the
      most effective composition of preventive health checks remains unknown.

      In a Danish municipality, the Check your Health Prevention Program (CHPP) was recently
      initiated, offering preventive health checks to all 30 to 49 year-old citizens. This program
      provides the unique opportunity to evaluate single components of a preventive health check in
      a real-life setting. Only a few previous studies have included cardiorespiratory fitness
      (fitness) testing in a preventive health check. Fitness is associated with multiple health
      benefits such as improved cardio-metabolic profile and reduced risk of cancer, diabetes, and
      depression.

      The investigators aim to investigate the effect of including fitness testing in preventive
      health checks on fitness level, motivation for changing physical activity behaviour, physical
      inactivity prevalence and self-rated health. The investigators hypothesize that fitness
      testing as part of preventive health checks compared to preventive health checks without
      fitness testing 1) increases fitness level assessed after one year and the percentage of
      participants increasing motivation to change physical activity behaviour assessed after two
      weeks, and 2) reduces physical inactivity prevalence and improves self-rated health scores
      during the one-year study period.

      METHODS

      Nested-design

      The present trial is embedded in the above mentioned health promotion program, CHPP, which is
      conducted during the years 2012 to 2017. In the CHPP, all citizens living in the municipality
      of Randers aged 30-49 years per 1st of January 2012 (n = 26,216) were identified in the
      Danish Civil Registration System.The identified population was randomized into five equal
      groups, one for each year of the CHPP. Invitations are dispatched continuously by mail and
      include information about the CHPP and a prefixed appointment for a health check. Health
      checks and health behavioural courses will take place at Randers Health Centre and health
      consultations at the citizen´s general practitioner.

      The health check

      Besides the addition of fitness testing in the intervention group, the preventive health
      checks will include assessments of the following: body weight and height, waist
      circumference, blood pressure, lipid profile (total cholesterol, LDL, HDL, and
      triglycerides), HbA1c and lung function. Moreover, a baseline questionnaire regarding
      physical activity level, motivation for changing physical activity behaviour, self-rated
      health, smoking, and alcohol will be answered in connection with the health check. At the end
      of the health check, the results are presented in a personalized health profile leaflet,
      which includes recommendations for follow-up according to the risk-profile. The baseline
      questionnaire and the subsequent follow-up procedures are identical in the two study groups.

      Standardization and education

      The health check will be conducted by health professionals who have been trained in all
      measurement procedures as well as in risk communication to ensure standardization and
      quality. Execution of the health check is further standardized by a written protocol and
      adherence to the protocol is checked continuously. Furthermore, a process evaluation will be
      conducted.

      Outcome assessment

      Cardiorespiratory fitness will be assessed by submaximal cycle ergometer testing. Motivation
      for changing physical activity behavior will be assessed using the Transtheoretical Model´s
      Stages of Change, and secondary outcomes using a modified version of the questions developed
      by Saltin and Grimby and the Short-Form 12, Health Survey, version 2.

      Follow up

      All participants will receive a questionnaire regarding motivation for changing physical
      activity behaviour two weeks after the health check and will be invited for fitness testing
      after one year.

      Randomization and blinding

      Randomization is handled by a data-manager with no scientific involvement. The eligible
      population for this trial was defined by the CHPP randomization. Citizens randomized for the
      third out of five years of the CHPP will be further randomized by household to either
      intervention or control in the present trial. The intervention, the outcomes, group
      assignment, and the future outcome assessments in this trial are unrevealed in the invitation
      for the CHPP. The health behavioural courses and the health consultations will be carried out
      un-blinded due to the real-life setting. At the one-year follow-up, the personnel assessing
      the outcomes will be independent and blinded to group allocation.

      Sample size

      An estimated sample size of 1,500 participants allows for a categorical analysis of fitness
      level and is calculated on the basis of the following assumptions: 1:1 randomization, false
      positive error rate of 0.05, power of 0.8, intracluster correlation coefficient of 0.05 and
      categorical analysis with a power to detect a difference of 10% in the prevalence of very low
      fitness between the study groups. The investigators determined this 10% difference to be
      clinically meaningful based on expert opinions and criteria employed in other research. The
      intracluster correlation coefficient was included to reflect a possible clustering effect of
      the general practitioners (n = 46), which is seldom greater than 0.05 in primary care
      settings. The estimated sample size accounts for a 30% loss to follow-up.

      Statistics

      Statistical analysis will be performed using STATA 12.0 software. Continuous variables are
      presented as mean ±standard deviation and categorical variables as absolute numbers and
      relative (%) frequencies. In the comparative analyses Student´s t-test will be used, when
      comparing means or changes in means of continuous variables and Chi2-test or Fisher's exact
      t-test, when comparing proportions for categorical variables. Analyses will be adjusted for
      baseline physical activity. Stratified analyses will be performed on sex and age groups and
      analysis of motivation will only be performed on the subgroup comprising precontemplaters,
      contemplaters, and preparators at baseline. All analyses will follow the intention-to-treat
      principle. If appropriate, multiple imputation methods will be applied (using data from
      social and medical national registries coupled with health check data), and sensitivity
      analyses will be performed. Moreover, the potential effect of clustering by the general
      practitioners will be investigated. The statistical significance level is set at p < 0.05.

      ETHICS AND LEGAL ASPECTS

      The trial will comply with The Declaration of Helsinki and each participant will provide
      written informed consent for data to be used for research purposes in agreement with the
      Danish Health Law. Approval by The Danish Data Protection Agency is obtained (2013-41-2527).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cardiorespiratory fitness
time frame: One-year follow up
description: Mean cardiorespiratory fitness level and the percentage of participants with very low cardiorespiratory fitness level assessed at the one year follow up will be compared between the two study groups.
measure: Reported physical inactivity prevalence change
time frame: Between baseline and the one-year follow up.
description: Change in reported physical inactivity prevalence from baseline to one-year follow up will be compared between the two study groups.
measure: Self-rated general health change
time frame: From baseline to the one-year follow up.
description: Change in self-rated general health from baseline to the one-year follow up will be compared between the two study groups.
measure: Self-rated physical health score change
time frame: From baseline to the one-year follow up.
description: Change in self-rated physical health scores from baseline to the one-year follow up will be compared between the two study groups.
measure: Self-rated mental health score change
time frame: From baseline to the one-year follow up.
description: Change in self-rated mental health scores from baseline to the one-year follow up will be compared between the two study groups.
measure: Stages of Change for physical activity
time frame: From baseline to an intermediate two-weeks follow up.
description: Stages of Change will be assessed at baseline and two weeks after the health check. Transitions in Stages of Change will be compared between study groups.
arm group label: Health checks with fitness testing
arm group type: Experimental
arm group label: Health checks without fitness testing
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Health checks with fitness testing
description: Fitness testing as part of a preventive health check compose the intervention in this trial. Thus, the intervention group will receive preventive health checks with fitness testing.
arm group label: Health checks with fitness testing
intervention type: Behavioral
intervention name: Health checks without fitness testing
description: The active comparator will not receive fitness testing as part of the preventive health checks. With the exception of fitness testing, the preventive health checks in the active comparator group and the intervention group are identical.
arm group label: Health checks without fitness testing
criteria: 
gender: All
minimum age: 30 Years
maximum age: 49 Years
healthy volunteers: No
last name: Annelli Sandbæk, Professor
role: Study Chair
affiliation: Institute of public health, section of general practice, Aarhus University
facility: 
country: Denmark
url: http://apps.who.int/iris/bitstream/10665/94384/1/9789241506236_eng.pdf?ua=1.
description: World Health Organization. Global action plan for the prevention and control of noncommunicable diseases 2013-2020
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responsible party type: Sponsor