ObesityRSANCT00604513
Ready. Set. ACTION! A Theater-Based Obesity Prevention Program for Children
A study testing Ready. Set. ACTION! Protocol in people with Obesity, run by University of Minnesota.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Ready. Set. ACTION! Protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 4th-6th grade children at intervention and control schools
- Parent or guardian of participating children
Who cannot join
- Other ages
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Ready. Set. ACTION! Protocol, Control
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready. Set. ACTION! ProtocolOther
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.
ControlOther
The control condition also participated in a theater-based intervention that addressed a health topic unrelated to weight, hand-washing and overall personal hygiene.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Ready. Set. ACTION! Protocol |
| 2 | Sham comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program feasibility
Measured: One school year
Secondary outcomes (5)
Body Mass Index (BMI)
Measured: One school-year
Physical activity
Measured: One school-year
Quality of dietary intake
Measured: One school-year
Self-efficacy to change eating and physical activity behaviors, improved body image, and improved self-esteem
Measured: One school-year
Parental support for healthy eating and physical activity
Measured: One school-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startSep 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dianne Neumark-Sztainer, PhD, MPH, RD, Principal investigator, Division of Epidemiology & Community Health, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604513
- Sponsor's protocol ID
- 0504S69518
- Other IDs
- R21DK072972
- Acronym
- RSA
- Status last verified
- Oct 2019
- First submitted
- 5 Dec 2007
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theater-Based Obesity Prevention Program for Children
- ClinicalTrials.gov ID
- NCT00604513
- Acronym / sponsor ID
- RSA / 0504S69518
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2006
- Study completion
- May 2007 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Ready. Set. ACTION! Protocol |
| 2 | Sham comparator | Other: Control |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 4th-6th grade children at intervention and control schools
- Parent or guardian of participating children
Key exclusion criteria (1 listed)
- Other ages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready. Set. ACTION! ProtocolThe 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. | Other | 1 |
| ControlThe control condition also participated in a theater-based intervention that addressed a health topic unrelated to weight, hand-washing and overall personal hygiene. | Other | 2 |
Primary outcome
Program feasibility
Time frame: One school year
5 secondary outcomes
Body Mass Index (BMI)
Time frame: One school-year
Physical activity
Time frame: One school-year
Quality of dietary intake
Time frame: One school-year
Self-efficacy to change eating and physical activity behaviors, improved body image, and improved self-esteem
Time frame: One school-year
Parental support for healthy eating and physical activity
Time frame: One school-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dianne Neumark-Sztainer, PhD, MPH, RD principal investigator
Division of Epidemiology & Community Health, University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Ready. Set. ACTION! Protocol in people with Obesity, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program feasibility (time frame: One school year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.