<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/NCT03759015</url>
  </required_header>
  <id_info>
    <org_study_id>1341383</org_study_id>
    <nct_id>NCT03759015</nct_id>
  </id_info>
  <brief_title>Evaluation of Health Education Theater</brief_title>
  <official_title>Evaluation of Health Education Theater</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      This study evaluates the feasibility and the potential positive health impacts of a novel&#xD;
      &quot;health education theater,&quot; which will task participants of a health education program to&#xD;
      create an original 10-minute theater that is required to use the health guidelines about&#xD;
      physical activity and diet/nutrition. The outcomes include the changes in (a) knowledge about&#xD;
      these guidelines, (b) compliance to these guidelines, (c) health related quality of life, and&#xD;
      (d) self-perception well-being measures such as self-esteem and self-efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 3, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge about the health guidelines regarding physical activity</measure>
    <time_frame>baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention</time_frame>
    <description>Knowledge about the guidelines regarding physical activity assessed via survey questionnaire. This outcome is dichotomous, either 0 or 1, representing a survey respondent's knowledge about the guideline is incorrect or correct, respectively. This guideline is set by the UC Davis Health Education and Promotion (HEP) (https://shcs.ucdavis.edu/wellness/physical-activity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in knowledge about the health guidelines regarding diet/nutrition</measure>
    <time_frame>baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention</time_frame>
    <description>Knowledge about the guidelines regarding diet/nutrition assessed via survey questionnaire. This outcome is dichotomous, either 0 or 1, representing a survey respondent's knowledge about the guideline is incorrect or correct, respectively. This guideline is set by the UC Davis Health Education and Promotion (HEP) (https://shcs.ucdavis.edu/fruits-andveggies).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in compliance about the health guidelines regarding physical activity</measure>
    <time_frame>baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention</time_frame>
    <description>Compliance about the guidelines regarding physical activity assessed via survey questionnaire. This outcome is dichotomous, either 0 or 1, representing a survey respondent is non-compliant or compliant to the guideline, respectively. This guideline is set by the UC Davis Health Education and Promotion (HEP) (https://shcs.ucdavis.edu/wellness/physical-activity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in compliance about the health guidelines regarding diet/nutrition</measure>
    <time_frame>baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention</time_frame>
    <description>Compliance about the guidelines regarding diet/nutrition assessed via survey questionnaire. This outcome is dichotomous, either 0 or 1, representing a survey respondent is non-compliant or compliant to the guideline, respectively. This guideline is set by the UC Davis Health Education and Promotion (HEP) (https://shcs.ucdavis.edu/fruits-andveggies).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in health related quality of life</measure>
    <time_frame>baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention</time_frame>
    <description>Health related quality of life will be measured with the unit of utility (ranging from 0 to 100), which will be derived with the established method of visual analogue scale following EuroQol Group (Health Policy. 1990;16(3):199-208).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-esteem</measure>
    <time_frame>baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention</time_frame>
    <description>Self-esteem will be measured by the established method of &quot;the Rosenberg's self-esteem scale,&quot; ranging from 10 to 40 (Rosenberg M. Society and the Adolescent Self-Image. Princeton, NJ, Princeton University Press, 1965).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-efficacy</measure>
    <time_frame>baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention</time_frame>
    <description>Self-efficacy will be measured by the established method of &quot;the Generalized self-efficacy scale,&quot; ranging from 10 to 40 (Schwarzer, R., &amp; Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, &amp;M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, England: NFER-NELSON.).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Economic efficiency of the intervention</measure>
    <time_frame>60 years after the end of the intervention based on a simulation analysis</time_frame>
    <description>Return on investment (ROI) of the intervention based on a simulation analysis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Community Health Education</condition>
  <arm_group>
    <arm_group_label>Health education</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This arm's subjects are tasked to create an original 10-minute theater that is required to use the guidelines about physical activity and diet/nutrition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health education</intervention_name>
    <description>All subjects are tasked to create an original 10-minute theater about physical activity and diet/nutrition.</description>
    <arm_group_label>Health education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  University of California (UC) Davis students who register for the course entitled &quot;&#xD;
             Health Education Theater,&quot; to be held during the 2019 Spring Quarter, i.e., from April&#xD;
             2019 to June 2019.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Individuals who are not compliant to this project's guideline of health limitations.&#xD;
             Under this project guideline, absences due to health limitations are not expected to&#xD;
             exceed 3 days maximum in addition to standard class policy during the quarter. As long&#xD;
             as a subject is compliant to this project guideline and the additional accommodations&#xD;
             authorized by the UC Davis Student Disability Center (SDC), any student (including a&#xD;
             pregnant woman student and a student with a disability) can participate in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California Davis</name>
      <address>
        <city>Davis</city>
        <state>California</state>
        <zip>95616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://studypages.com/s/an-evaluation-of-the-health-education-theater-course-151816/</url>
    <description>Learn more or sign up for the study here!</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03759015
org study id: 1341383
nct id: NCT03759015
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the feasibility and the potential positive health impacts of a novel
      "health education theater," which will task participants of a health education program to
      create an original 10-minute theater that is required to use the health guidelines about
      physical activity and diet/nutrition. The outcomes include the changes in (a) knowledge about
      these guidelines, (b) compliance to these guidelines, (c) health related quality of life, and
      (d) self-perception well-being measures such as self-esteem and self-efficacy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in knowledge about the health guidelines regarding physical activity
time frame: baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention
description: Knowledge about the guidelines regarding physical activity assessed via survey questionnaire. This outcome is dichotomous, either 0 or 1, representing a survey respondent's knowledge about the guideline is incorrect or correct, respectively. This guideline is set by the UC Davis Health Education and Promotion (HEP) (https://shcs.ucdavis.edu/wellness/physical-activity).
measure: Change in knowledge about the health guidelines regarding diet/nutrition
time frame: baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention
description: Knowledge about the guidelines regarding diet/nutrition assessed via survey questionnaire. This outcome is dichotomous, either 0 or 1, representing a survey respondent's knowledge about the guideline is incorrect or correct, respectively. This guideline is set by the UC Davis Health Education and Promotion (HEP) (https://shcs.ucdavis.edu/fruits-andveggies).
measure: Change in compliance about the health guidelines regarding physical activity
time frame: baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention
description: Compliance about the guidelines regarding physical activity assessed via survey questionnaire. This outcome is dichotomous, either 0 or 1, representing a survey respondent is non-compliant or compliant to the guideline, respectively. This guideline is set by the UC Davis Health Education and Promotion (HEP) (https://shcs.ucdavis.edu/wellness/physical-activity).
measure: Change in compliance about the health guidelines regarding diet/nutrition
time frame: baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention
description: Compliance about the guidelines regarding diet/nutrition assessed via survey questionnaire. This outcome is dichotomous, either 0 or 1, representing a survey respondent is non-compliant or compliant to the guideline, respectively. This guideline is set by the UC Davis Health Education and Promotion (HEP) (https://shcs.ucdavis.edu/fruits-andveggies).
measure: Change in health related quality of life
time frame: baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention
description: Health related quality of life will be measured with the unit of utility (ranging from 0 to 100), which will be derived with the established method of visual analogue scale following EuroQol Group (Health Policy. 1990;16(3):199-208).
measure: Change in self-esteem
time frame: baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention
description: Self-esteem will be measured by the established method of "the Rosenberg's self-esteem scale," ranging from 10 to 40 (Rosenberg M. Society and the Adolescent Self-Image. Princeton, NJ, Princeton University Press, 1965).
measure: Change in self-efficacy
time frame: baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention
description: Self-efficacy will be measured by the established method of "the Generalized self-efficacy scale," ranging from 10 to 40 (Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, &M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, England: NFER-NELSON.).
measure: Economic efficiency of the intervention
time frame: 60 years after the end of the intervention based on a simulation analysis
description: Return on investment (ROI) of the intervention based on a simulation analysis
arm group label: Health education
arm group type: Other
description: This arm's subjects are tasked to create an original 10-minute theater that is required to use the guidelines about physical activity and diet/nutrition.
intervention type: Behavioral
intervention name: Health education
description: All subjects are tasked to create an original 10-minute theater about physical activity and diet/nutrition.
arm group label: Health education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: https://studypages.com/s/an-evaluation-of-the-health-education-theater-course-151816/
description: Learn more or sign up for the study here!
responsible party type: Sponsor
sharing ipd: No