Health BehaviorGROOVENCT02187939
Get in the GROOVE!
A study testing Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle. in people with Health Behavior and Prevention Harmful Effects, run by University of Miami at 2 sites in United States.
Trial summary
Get in the GROOVE! will address health disparities impacting underserved youth. Given the alarming rate of overweight and obesity among high school minority youth, the project will focus on middle school with the primary aim of reaching middle school girls before unhealthy habits become firmly ingrained. Read more about this study
- Who is it for?
- Ages 11 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Prevention Harmful Effects
- What is being tested?
- Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Jan 2017
- 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 11 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Girls 11-14 years old
Who cannot join
- Girls are excluded if they are:
- not fluent in English
- enrolled in a special education program at school (other than gifted program) that would interfere with ability to master the material
- have a condition that would preclude their participation in the dance activities of the summer program
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Patricia and Phillip Museum of Science
Miami, Florida, 33129
New York Hall of Science
Queens, New York, 11368
About this study
Official title: Get in the GROOVE (Girls Realizing Options Through OpenSim Virtual Experiences)!
Get in the GROOVE! will address health disparities impacting underserved youth. Given the alarming rate of overweight and obesity among high school minority youth, the project will focus on middle school with the primary aim of reaching middle school girls before unhealthy habits become firmly ingrained.
The primary aim of the research project is to investigate the impact of two types of summer science enrichment programs (that focus on health and wellness) on middle school girls' self-efficacy, health knowledge, health behaviors, and interest in science. One program will present the curriculum by conventional means (GROOVE condition) while the second program will include the addition of a closed 3-D virtual world environment to reinforce concepts (GROOVE+ condition).
Read more
The following hypotheses will be tested in the randomized controlled trial:
- Upon completion of the summer program, the enhanced summer program GROOVE+ relative to the conventional summer program will result in a) increased self-efficacy for adopting healthy behavior change; b) increased health knowledge; c) enhanced science self-concept; and e) more positive behavior change (e.g., improved nutrition, increased physical activity).
- At follow-up, the enhanced summer program relative to the conventional summer program will result in further and/or sustained improvements in positive behavior health behaviors and attitudes.
- Conditions
- Health Behavior, Prevention Harmful Effects
- Being tested
- Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.Other
The enhanced virtual world education (GROOVE+) will be compared to conventional approach (GROOVE). Each program is Monday-Friday, 9:30-3:30, for 3 weeks in the summer.
| Study group | Role | What they receive |
|---|---|---|
| Summer wellness program - nutrition & physical activity | Active comparator | The GROOVE condition uses conventional means to address health-related activities and content within the context of a science museum summer enrichment program. The emphasis is on nutrition, physical activity, and healthy lifestyle. Receives: Other: Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle. |
| Summer program plus virtual world technology | Experimental | The GROOVE+ condition enhances the conventional approach to address health-related activities and content within the context of a science museum summer enrichment program by employing technology and a 3-D virtual world as a key educational strategy. The emphasis is on nutrition, physical activity, and healthy lifestyle. Receives: Other: Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Health Knowledge
Multiple choice questionnaire used to assess participants' health knowledge pertaining to nutrition, physical activity, weight, and lifestyle. The measure will test for the content of the summer program.
Measured: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
Secondary outcomes (3)
change in Self-efficacy - physical activity
The physical activity self-efficacy support seeking and barriers subscales developed by Saunders, Pate, Felton et al.'s (1997, Preventive Medicine, vol. 26, 241-247) will be used.
Measured: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
change in Self-efficacy - fruit and vegetable consumption
The food-related self-efficacy scale items comes from the work of Reynolds et al. ( 2002, Health Psychology, vol. 21, 51-60) and addresses fruit and vegetable consumption.
Measured: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
change in Self-efficacy - science
Science self-efficacy assesses confidence to master the GROOVE program science components.
Measured: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMay 2013
- Primary completionSep 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Patricia and Phillip Frost Museum of Science (formerly known as Miami Science Museum), New York Hall of Science, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Patrice G. Saab, University of Miami
- Investigators
- Patrice G Saab, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187939
- Sponsor's protocol ID
- 20111081
- Other IDs
- 5R25OD010525
- Acronym
- GROOVE
- Status last verified
- Feb 2017
- First submitted
- 30 Jun 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get in the GROOVE (Girls Realizing Options Through OpenSim Virtual Experiences)!
- ClinicalTrials.gov ID
- NCT02187939
- Acronym / sponsor ID
- GROOVE / 20111081
- Conditions
- Health Behavior, Prevention Harmful Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Patricia and Phillip Frost Museum of Science (formerly known as Miami Science Museum), New York Hall of Science, National Institutes of Health (NIH)
- Study start
- May 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Jul 2014 (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.
Get in the GROOVE! will address health disparities impacting underserved youth. Given the alarming rate of overweight and obesity among high school minority youth, the project will focus on middle school with the primary aim of reaching middle school girls before unhealthy habits become firmly ingrained.
The primary aim of the research project is to investigate the impact of two types of summer science enrichment programs (that focus on health and wellness) on middle school girls' self-efficacy, health knowledge, health behaviors, and interest in science. One program will present the curriculum by conventional means (GROOVE condition) while the second program will include the addition of a closed 3-D virtual world environment to reinforce concepts (GROOVE+ condition).
The following hypotheses will be tested in the randomized controlled trial:
- Upon completion of the summer program, the enhanced summer program GROOVE+ relative to the conventional summer program will result in a) increased self-efficacy for adopting healthy behavior change; b) increased health knowledge; c) enhanced science self-concept; and e) more positive behavior change (e.g., improved nutrition, increased physical activity).
- At follow-up, the enhanced summer program relative to the conventional summer program will result in further and/or sustained improvements in positive behavior health behaviors and attitudes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Summer wellness program - nutrition & physical activity | Active comparator | Other: Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.The GROOVE condition uses conventional means to address health-related activities and content within the context of a science museum summer enrichment program. The emphasis is on nutrition, physical activity, and healthy lifestyle. |
| Summer program plus virtual world technology | Experimental | Other: Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.The GROOVE+ condition enhances the conventional approach to address health-related activities and content within the context of a science museum summer enrichment program by employing technology and a 3-D virtual world as a key educational strategy. The emphasis is on nutrition, physical activity, and healthy lifestyle. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Girls 11-14 years old
Key exclusion criteria (4 listed)
- not fluent in English
- enrolled in a special education program at school (other than gifted program) that would interfere with ability to master the material
- have a condition that would preclude their participation in the dance activities of the summer program
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 |
|---|---|---|
| Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.The enhanced virtual world education (GROOVE+) will be compared to conventional approach (GROOVE). Each program is Monday-Friday, 9:30-3:30, for 3 weeks in the summer. | Other | Summer program plus virtual world technology, Summer wellness program - nutrition & physical activity |
Primary outcome
change in Health Knowledge
Time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
Multiple choice questionnaire used to assess participants' health knowledge pertaining to nutrition, physical activity, weight, and lifestyle. The measure will test for the content of the summer program.
3 secondary outcomes
change in Self-efficacy - physical activity
Time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
change in Self-efficacy - fruit and vegetable consumption
Time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
change in Self-efficacy - science
Time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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 23 Feb 2017.
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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.
Patrice G Saab, Ph.D. principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle. in people with Health Behavior and Prevention Harmful Effects, run by University of Miami at 2 sites in United States.
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 1 inclusion and 4 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
change in Health Knowledge (time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)). 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 23 Feb 2017.