<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/NCT02999425</url>
  </required_header>
  <id_info>
    <org_study_id>ASA-1617</org_study_id>
    <nct_id>NCT02999425</nct_id>
  </id_info>
  <brief_title>Effectiveness of Targeted Educational Intervention on Healthy Lifestyle Behaviors in Serbian Population</brief_title>
  <official_title>Effectiveness of Targeted Educational Intervention on Healthy Lifestyle Behaviors in Serbian Population: Make Right Choices Fro Lifelong Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center for Health, Exercise and Sport Sciences, Serbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Center for Health, Exercise and Sport Sciences, Serbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall idea to be evaluated in this project is that educational activities providing&#xD;
      top-notch knowledge on diet and physical activity may represent an additional benefit to the&#xD;
      strategies aimed at decreasing lifestyle diseases in Serbian population of both young and&#xD;
      mature age. The specific objectives of this project are:&#xD;
&#xD;
        1. to develop user-friendly guidelines for physical activity and nutrition for two age&#xD;
           group cohorts (K-12 and adults) of Serbia residents;&#xD;
&#xD;
        2. to provide a brief educational intervention about nutrition and healthy lifestyles at&#xD;
           school or work settings in each age group;&#xD;
&#xD;
        3. to determine if an educational intervention would yield an additional benefit in the&#xD;
           acquisition of knowledge on nutrition and physical activity;&#xD;
&#xD;
        4. to promote and disseminate project results using popular media, non-professional and&#xD;
           professional bodies and relevant events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the first stage of the project, investigators will recruit national experts from academia&#xD;
      and governmental bodies to develop distinctive user-friendly guidelines on nutrition and&#xD;
      physical activity based on gold-standard recommendations currently available, from the US&#xD;
      Centers for Disease Control and Prevention, World Health Organization, American College of&#xD;
      Sports Medicine and American Heart Association. Intended for general public, two laymen&#xD;
      guidelines will be produced, each for a specific age group (K-12 and adults), with both&#xD;
      documents outline how people can improve their overall eating patterns and how children and&#xD;
      adults can improve their health through physical activity. For the second stage, ~ 2.000&#xD;
      participants (a nationally representative sample of K-12 and adult age group) will&#xD;
      participate in a tailored educational intervention delivered by CHESS experts (health&#xD;
      professional and physical education teachers), with a summary of above layman reports&#xD;
      delivered to recruited participants via 50 oral sessions. Both groups will complete pre- and&#xD;
      post-intervention questionnaires of the Health-Promoting Lifestyle Profile (HPLS) and&#xD;
      Short-Form Health Survey, standard easy-to-administer questionnaires that measure&#xD;
      health-promoting lifestyle knowledge in different scales. In the third phase, investigators&#xD;
      will compare the effectiveness of targeted health-promoting education, comparing&#xD;
      pre-intervention vs. post-intervention (at 3 months) HPLS total scores. Collected data will&#xD;
      be organized in nationally recognized Open Access database, with descriptive information on&#xD;
      all relevant outcomes presented in user-friendly electronic format for whole sample and each&#xD;
      age-specific sub-population. Finally, both guidelines on nutrition and physical activity, and&#xD;
      the outcomes on educational intervention to promote healthy lifestyles among K-12 and adult&#xD;
      population will be further disseminated:&#xD;
&#xD;
        1. to general public through media, conferences and Layman's report;&#xD;
&#xD;
        2. to interested and relevant stakeholders in the field of health, education and sport&#xD;
           through overview in brief memorandum; and&#xD;
&#xD;
        3. to professional bodies and groups through interactive meetings and workshops.&#xD;
&#xD;
      Finally, the results will be further disseminated at relevant conferences, e-media and&#xD;
      journal papers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge assessed on the Health-Promoting Lifestyle Profile</measure>
    <time_frame>Change from Baseline Knowledge at 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life assessed on the Short-Form Health Survey</measure>
    <time_frame>Change from Baseline Health-Related Quality of Life at 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3822</enrollment>
  <condition>Behavior</condition>
  <arm_group>
    <arm_group_label>Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational intervention to study participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Educational intervention</description>
    <arm_group_label>Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General population older than 10 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sergej M Ostojic, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Center for Health, Exercise and Sport Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Health, Exercise and Sport Sciences</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <reference>
    <citation>Holt AM, Jancey J, Lee AH, Kerr DA, Hills AP, Anderson AS, Howat PA. A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol. BMJ Open. 2014 Sep 25;4(9):e005107. doi: 10.1136/bmjopen-2014-005107.</citation>
    <PMID>25256185</PMID>
  </reference>
  <reference>
    <citation>Gillison F, Standage M, Verplanken B. A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods. BMC Public Health. 2014 Mar 4;14:221. doi: 10.1186/1471-2458-14-221.</citation>
    <PMID>24592967</PMID>
  </reference>
  <reference>
    <citation>Morgan PJ, Collins CE, Plotnikoff RC, Callister R, Burrows T, Fletcher R, Okely AD, Young MD, Miller A, Lloyd AB, Cook AT, Cruickshank J, Saunders KL, Lubans DR. The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children. Prev Med. 2014 Apr;61:90-9. doi: 10.1016/j.ypmed.2013.12.019. Epub 2013 Dec 29.</citation>
    <PMID>24380796</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Assessed outcomes will be shared via open database when study finished, via direct contact with PI</ipd_description>
  </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/NCT02999425
org study id: ASA-1617
nct id: NCT02999425
lead sponsor: 
has dmc: No
The overall idea to be evaluated in this project is that educational activities providing
      top-notch knowledge on diet and physical activity may represent an additional benefit to the
      strategies aimed at decreasing lifestyle diseases in Serbian population of both young and
      mature age. The specific objectives of this project are:

        1. to develop user-friendly guidelines for physical activity and nutrition for two age
           group cohorts (K-12 and adults) of Serbia residents;

        2. to provide a brief educational intervention about nutrition and healthy lifestyles at
           school or work settings in each age group;

        3. to determine if an educational intervention would yield an additional benefit in the
           acquisition of knowledge on nutrition and physical activity;

        4. to promote and disseminate project results using popular media, non-professional and
           professional bodies and relevant events.
In the first stage of the project, investigators will recruit national experts from academia
      and governmental bodies to develop distinctive user-friendly guidelines on nutrition and
      physical activity based on gold-standard recommendations currently available, from the US
      Centers for Disease Control and Prevention, World Health Organization, American College of
      Sports Medicine and American Heart Association. Intended for general public, two laymen
      guidelines will be produced, each for a specific age group (K-12 and adults), with both
      documents outline how people can improve their overall eating patterns and how children and
      adults can improve their health through physical activity. For the second stage, ~ 2.000
      participants (a nationally representative sample of K-12 and adult age group) will
      participate in a tailored educational intervention delivered by CHESS experts (health
      professional and physical education teachers), with a summary of above layman reports
      delivered to recruited participants via 50 oral sessions. Both groups will complete pre- and
      post-intervention questionnaires of the Health-Promoting Lifestyle Profile (HPLS) and
      Short-Form Health Survey, standard easy-to-administer questionnaires that measure
      health-promoting lifestyle knowledge in different scales. In the third phase, investigators
      will compare the effectiveness of targeted health-promoting education, comparing
      pre-intervention vs. post-intervention (at 3 months) HPLS total scores. Collected data will
      be organized in nationally recognized Open Access database, with descriptive information on
      all relevant outcomes presented in user-friendly electronic format for whole sample and each
      age-specific sub-population. Finally, both guidelines on nutrition and physical activity, and
      the outcomes on educational intervention to promote healthy lifestyles among K-12 and adult
      population will be further disseminated:

        1. to general public through media, conferences and Layman's report;

        2. to interested and relevant stakeholders in the field of health, education and sport
           through overview in brief memorandum; and

        3. to professional bodies and groups through interactive meetings and workshops.

      Finally, the results will be further disseminated at relevant conferences, e-media and
      journal papers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Knowledge assessed on the Health-Promoting Lifestyle Profile
time frame: Change from Baseline Knowledge at 3 months
measure: Health-Related Quality of Life assessed on the Short-Form Health Survey
time frame: Change from Baseline Health-Related Quality of Life at 3 months
arm group label: Education
arm group type: Experimental
description: Educational intervention to study participants
intervention type: Other
intervention name: Education
description: Educational intervention
arm group label: Education
criteria: 
gender: All
minimum age: 10 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sergej M Ostojic, MD, PhD
role: Study Chair
affiliation: Center for Health, Exercise and Sport Sciences
facility: 
country: Serbia
citation: Holt AM, Jancey J, Lee AH, Kerr DA, Hills AP, Anderson AS, Howat PA. A cluster-randomised controlled trial of a physical activity and nutrition programme in retirement villages: a study protocol. BMJ Open. 2014 Sep 25;4(9):e005107. doi: 10.1136/bmjopen-2014-005107.
PMID: 25256185
citation: Gillison F, Standage M, Verplanken B. A cluster randomised controlled trial of an intervention to promote healthy lifestyle habits to school leavers: study rationale, design, and methods. BMC Public Health. 2014 Mar 4;14:221. doi: 10.1186/1471-2458-14-221.
PMID: 24592967
citation: Morgan PJ, Collins CE, Plotnikoff RC, Callister R, Burrows T, Fletcher R, Okely AD, Young MD, Miller A, Lloyd AB, Cook AT, Cruickshank J, Saunders KL, Lubans DR. The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children. Prev Med. 2014 Apr;61:90-9. doi: 10.1016/j.ypmed.2013.12.019. Epub 2013 Dec 29.
PMID: 24380796
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Assessed outcomes will be shared via open database when study finished, via direct contact with PI