NCT03759015

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Apr 2019Jun 2026

First Submitted

Initial submission to the registry

November 26, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

April 3, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

November 26, 2018

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Economic efficiency of the intervention

    60 years after the end of the intervention based on a simulation analysis

Study Arms (1)

Health education

OTHER

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

Interventions

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

Health education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Davis, California, 95616, United States

Location

Related Links

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 29, 2018

Study Start

April 3, 2019

Primary Completion

December 31, 2020

Study Completion (Estimated)

June 30, 2026

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations