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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03759015
Other study ID # 1341383
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 3, 2019
Est. completion date June 30, 2024

Study information

Verified date June 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 10
Est. completion date June 30, 2024
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Health education
All subjects are tasked to create an original 10-minute theater about physical activity and diet/nutrition.

Locations

Country Name City State
United States University of California Davis Davis California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in knowledge about the health guidelines regarding physical activity 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
Primary Change in knowledge about the health guidelines regarding diet/nutrition 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
Primary Change in compliance about the health guidelines regarding physical activity 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
Primary Change in compliance about the health guidelines regarding diet/nutrition 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
Primary Change in health related quality of life 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
Primary Change in self-esteem 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
Primary Change in self-efficacy 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 Economic efficiency of the intervention 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
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