- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00604513
Ready. Set. ACTION! A Theater-Based Obesity Prevention Program for Children (RSA)
October 30, 2019 updated by: University of Minnesota
A Theater-Based Obesity Prevention Program for Children
The goal of Ready, Set, ACTION! (RSA) is to test the feasibility of implementing a theater-based after-school program to promote healthy eating, physical activity, and positive body image with children in grades four through six.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The goal of Ready, Set, ACTION! (RSA) is to test the feasibility of implementing a theater-based after-school program to promote healthy eating, physical activity, and positive body image with children in grades four through six.
This study, funded by the National Institutes of Health (NIDDK), is a collaboration between the University of Minnesota, Division of Epidemiology and Community Health, Saint Paul Public Schools, and Illusion Theater of Minneapolis.
Four participating Saint Paul schools were randomly assigned to receive either a control or intervention after school program led by artists/educators from Illusion Theater.
Students in the intervention schools received a fourteen-session curriculum with eight booster sessions, in which they received the following messages: increase fruit, vegetable, and water consumption, decrease soda pop, increase physical activity, and decrease television.
Families received nutrition and activity information packets themed for each session.
The messages were reinforced by theater education, dance, and music.
A play structured around the aforementioned messages that included scene vignettes, choreographed dance, and professionally composed music was developed and rehearsed by the children.
In December 2006 the children performed the play for their families at Illusion Theater in downtown Minneapolis.
They later performed for their peers at school and again for family and school administrators at the conclusion of the program.
Study Type
Interventional
Enrollment (Actual)
181
Phase
- Not Applicable
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
8 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 4th-6th grade children at intervention and control schools
- Parent or guardian of participating children
Exclusion Criteria:
- Other ages
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
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The intervention included three components: theater sessions; booster sessions; and family outreach.
After-school theater sessions were conducted in the fall in the intervention schools.
Sessions included: a "check-in" about changes made over the past week; healthy snacks; a movement component that involved fun and easy activities; and creating/education.
Children at intervention schools participated in weekly after-school booster sessions in the winter to further address the behavioral messages addressed during the intervention.
Throughout the program, weekly Fun & Fitness packs were sent home to families that included a healthy food with a simple recipe using that food or fitness incentives for the family.
There were also two family events: a theater performance, and a reception.
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|
Sham Comparator: 2
|
The control condition also participated in a theater-based intervention that addressed a health topic unrelated to weight, hand-washing and overall personal hygiene.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Program feasibility
Time Frame: One school year
|
One school year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Body Mass Index (BMI)
Time Frame: One school-year
|
One school-year
|
|
Physical activity
Time Frame: One school-year
|
One school-year
|
|
Quality of dietary intake
Time Frame: One school-year
|
One school-year
|
|
Self-efficacy to change eating and physical activity behaviors, improved body image, and improved self-esteem
Time Frame: One school-year
|
One school-year
|
|
Parental support for healthy eating and physical activity
Time Frame: One school-year
|
One school-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dianne Neumark-Sztainer, PhD, MPH, RD, Division of Epidemiology & Community Health, University of Minnesota
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
September 1, 2006
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
December 5, 2007
First Submitted That Met QC Criteria
January 17, 2008
First Posted (Estimate)
January 30, 2008
Study Record Updates
Last Update Posted (Actual)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0504S69518
- R21DK072972 (U.S. NIH Grant/Contract)
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.