- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03759015
Evaluation of Health Education Theater
June 16, 2023 updated by: University of California, Davis
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Davis, California, United States, 95616
- University of California Davis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
All subjects are tasked to create an original 10-minute theater about physical activity and diet/nutrition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention
|
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).
|
baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention
|
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).
|
baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention
|
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).
|
baseline, immediately post-intervention, 6 months post-intervention, 12-months post-intervention
|
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).
|
baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention
|
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).
|
baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention
|
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.).
|
baseline, immediately post-intervention, 6 months postintervention, 12-months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
60 years after the end of the intervention based on a simulation analysis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2019
Primary Completion (Actual)
December 31, 2020
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
November 26, 2018
First Submitted That Met QC Criteria
November 27, 2018
First Posted (Actual)
November 29, 2018
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 16, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 1341383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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