Get in the GROOVE! (GROOVE)

February 20, 2017 updated by: Patrice G. Saab, University of Miami

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:

  1. 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).
  2. 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
375

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
Patricia and Phillip Frost Museum of Science (formerly known as Miami Science Museum)
New York Hall of Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrice G Saab, Ph.D., University of Miami

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20111081
  • 5R25OD010525 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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