- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02187939
Get in the GROOVE! (GROOVE)
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).
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33129
- Patricia and Phillip Museum of Science
-
-
New York
-
Queens, New York, United States, 11368
- New York Hall of Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Girls 11-14 years old
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Summer wellness program - nutrition & physical activity
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.
|
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.
|
Experimental: Summer program plus virtual world technology
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in Self-efficacy - physical activity
Time Frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
|
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.
|
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)
|
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.
|
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)
|
Science self-efficacy assesses confidence to master the GROOVE program science components.
|
pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in health behaviors
Time Frame: pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
|
eating habits and physical activity habits
|
pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
|
change in Science attitudes and aspirations
Time Frame: pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
|
This measure consist of items drawn from Louise Archer et al.'s (2013, Journal of Education Policy, 1-28, http://www.tandfonline.com/doi/abs/10.1080/02680939.2013.790079#.UbDmUuARtm1) ASPIRES project.
Participants are asked to make ratings reflecting science attitudes, aspirations, and interests.
|
pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
|
change in Family and participant habits
Time Frame: pretreatment ( Day1-2), post treatment (end of 3 week summer session - for participant only), and up to a year follow-up
|
Assesses family and participant activities and habits and ratings of participant health and interests.
|
pretreatment ( Day1-2), post treatment (end of 3 week summer session - for participant only), and up to a year follow-up
|
change in Pedometer activity
Time Frame: Participants will be given a pedometer to wear during the 3 week summer program period
|
Pedometers will be used daily to assess physical activity.
|
Participants will be given a pedometer to wear during the 3 week summer program period
|
Change in eating behavior
Time Frame: Up to 4 assessments will occur over the 3 week program.
|
The Eating Behavior Scale consists of 28 items; all 20 items from Fahlman et al. (2013, American Journal of Health Education, vol.
43, 165-171) and 8 additional items from the 2009-2010 School Physical Activity and Nutrition Project (https://sph.uth.edu/content/uploads/2011/12/SPAN_2009-10_8th-11thStudentSurveyEnglish_FINAL.pdf).
The measure asks participants to indicate how many times they consumed an item on the day before (e.g., fruits, vegetables, candy, etc).
A subsample of students will complete up to three 24-hour dietary recalls to examine the validity of the self-report items in the study's participants.
|
Up to 4 assessments will occur over the 3 week program.
|
change in Presence
Time Frame: up to 3 times during the GROOVE+ condition
|
The presence scale consists of 11 items influenced by the work of Fox et al. (2009, Presence Vol.
18,294-303) will be completed by the participants in the GROOVE+ condition.
The scale assesses the extent to which the participant feels present in the 3-D virtual world.
|
up to 3 times during the GROOVE+ condition
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrice G Saab, Ph.D., University of Miami
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20111081
- 5R25OD010525 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Prevention Harmful Effects
-
Boston Children's HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedPrevention Harmful EffectsUnited States
-
EuBiologics Co.,LtdInstituto Universitario IVICompletedPrevention Harmful EffectsPhilippines
-
Karolinska InstitutetNot yet recruitingPrevention Harmful EffectsSweden
-
Zurich University of Applied SciencesUniversitat Politècnica de ValènciaCompletedPrevention Harmful Effects
-
M.D. Anderson Cancer CenterWithdrawnCancer | Prevention Harmful Effects
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; National Institute of Nursing Research (NINR); Pennsylvania...CompletedPrevention Harmful Effects | Accidents, Traffic | Accident PreventionUnited States
-
Shanghai Changning Maternity & Infant Health HospitalTongji UniversityUnknown
-
University of South CarolinaCompletedPrevention Harmful EffectsUnited States
-
Tel Aviv UniversityIsrael Science FoundationCompletedPrevention Harmful EffectsIsrael
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Unknown
Clinical Trials on Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.
-
Universidade Estadual Paulista Júlio de Mesquita...Fundação de Amparo à Pesquisa do Estado de São PauloCompletedPhysical Activity | Sedentary Lifestyle | Adolescent Behavior | Eating BehaviorBrazil
-
Saglik Bilimleri UniversitesiCompletedPublic Health NursingTurkey
-
Instituto de Seguridad y Servicios Sociales de...CompletedLiver Diseases | Kidney Diseases | Obesity | Diabetes Mellitus, Type 2 | Physical Fitness | Cardiovascular FunctionMexico
-
Wang JingjingCompleted