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Evaluation of Health Education Theater

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ClinicalTrials.gov Identifier: NCT03759015
Recruitment Status : Active, not recruiting
First Posted : November 29, 2018
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Community Health Education Behavioral: Health education Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Health Education Theater
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Health education
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.
 Behavioral: Health education
All subjects are tasked to create an original 10-minute theater about physical activity and diet/nutrition.


Outcome Measures
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Primary Outcome Measures :
  1. Change in knowledge about the health guidelines regarding physical activity [ Time Frame: baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention ]
    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).

  2. Change in knowledge about the health guidelines regarding diet/nutrition [ Time Frame: baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention ]
    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).

  3. Change in compliance about the health guidelines regarding physical activity [ Time Frame: baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention ]
    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).

  4. Change in compliance about the health guidelines regarding diet/nutrition [ Time Frame: baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention ]
    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).

  5. Change in health related quality of life [ Time Frame: baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention ]
    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).

  6. Change in self-esteem [ Time Frame: baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention ]
    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).

  7. Change in self-efficacy [ Time Frame: baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention ]
    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.).


Secondary Outcome Measures :
  1. Economic efficiency of the intervention [ Time Frame: 60 years after the end of the intervention based on a simulation analysis ]
    Return on investment (ROI) of the intervention based on a simulation analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • University of California (UC) Davis students who register for the course entitled " Health Education Theater," to be held during the 2019 Spring Quarter, i.e., from April 2019 to June 2019.

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Prisoners
  • Individuals who are not compliant to this project's guideline of health limitations. Under this project guideline, absences due to health limitations are not expected to exceed 3 days maximum in addition to standard class policy during the quarter. As long as a subject is compliant to this project guideline and the additional accommodations authorized by the UC Davis Student Disability Center (SDC), any student (including a pregnant woman student and a student with a disability) can participate in this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759015


Locations
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United States, California
University of California Davis
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
More Information
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Additional Information:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03759015    
Other Study ID Numbers: 1341383
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No