<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02187939</url>
  </required_header>
  <id_info>
    <org_study_id>20111081</org_study_id>
    <secondary_id>5R25OD010525</secondary_id>
    <nct_id>NCT02187939</nct_id>
  </id_info>
  <brief_title>Get in the GROOVE!</brief_title>
  <acronym>GROOVE</acronym>
  <official_title>Get in the GROOVE (Girls Realizing Options Through OpenSim Virtual Experiences)!</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patricia and Phillip Frost Museum of Science (formerly known as Miami Science Museum)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York Hall of Science</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Get in the GROOVE! will address health disparities impacting underserved youth. Given the&#xD;
      alarming rate of overweight and obesity among high school minority youth, the project will&#xD;
      focus on middle school with the primary aim of reaching middle school girls before unhealthy&#xD;
      habits become firmly ingrained.&#xD;
&#xD;
      The primary aim of the research project is to investigate the impact of two types of summer&#xD;
      science enrichment programs (that focus on health and wellness) on middle school girls'&#xD;
      self-efficacy, health knowledge, health behaviors, and interest in science. One program will&#xD;
      present the curriculum by conventional means (GROOVE condition) while the second program will&#xD;
      include the addition of a closed 3-D virtual world environment to reinforce concepts (GROOVE+&#xD;
      condition).&#xD;
&#xD;
      The following hypotheses will be tested in the randomized controlled trial:&#xD;
&#xD;
        1. Upon completion of the summer program, the enhanced summer program GROOVE+ relative to&#xD;
           the conventional summer program will result in a) increased self-efficacy for adopting&#xD;
           healthy behavior change; b) increased health knowledge; c) enhanced science&#xD;
           self-concept; and e) more positive behavior change (e.g., improved nutrition, increased&#xD;
           physical activity).&#xD;
&#xD;
        2. At follow-up, the enhanced summer program relative to the conventional summer program&#xD;
           will result in further and/or sustained improvements in positive behavior health&#xD;
           behaviors and attitudes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Health Knowledge</measure>
    <time_frame>pretreatment ( Day1-2) and post treatment (end of 3 week summer session)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in Self-efficacy - physical activity</measure>
    <time_frame>pretreatment ( Day1-2) and post treatment (end of 3 week summer session)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Self-efficacy - fruit and vegetable consumption</measure>
    <time_frame>pretreatment ( Day1-2) and post treatment (end of 3 week summer session)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in Self-efficacy - science</measure>
    <time_frame>pretreatment ( Day1-2) and post treatment (end of 3 week summer session)</time_frame>
    <description>Science self-efficacy assesses confidence to master the GROOVE program science components.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>change in health behaviors</measure>
    <time_frame>pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up</time_frame>
    <description>eating habits and physical activity habits</description>
  </other_outcome>
  <other_outcome>
    <measure>change in Science attitudes and aspirations</measure>
    <time_frame>pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>change in Family and participant habits</measure>
    <time_frame>pretreatment ( Day1-2), post treatment (end of 3 week summer session - for participant only), and up to a year follow-up</time_frame>
    <description>Assesses family and participant activities and habits and ratings of participant health and interests.</description>
  </other_outcome>
  <other_outcome>
    <measure>change in Pedometer activity</measure>
    <time_frame>Participants will be given a pedometer to wear during the 3 week summer program period</time_frame>
    <description>Pedometers will be used daily to assess physical activity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in eating behavior</measure>
    <time_frame>Up to 4 assessments will occur over the 3 week program.</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>change in Presence</measure>
    <time_frame>up to 3 times during the GROOVE+ condition</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">375</enrollment>
  <condition>Health Behavior</condition>
  <condition>Prevention Harmful Effects</condition>
  <arm_group>
    <arm_group_label>Summer wellness program - nutrition &amp; physical activity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Summer program plus virtual world technology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.</intervention_name>
    <description>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.</description>
    <arm_group_label>Summer program plus virtual world technology</arm_group_label>
    <arm_group_label>Summer wellness program - nutrition &amp; physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Girls 11-14 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Girls are excluded if they are:&#xD;
&#xD;
          -  not fluent in English&#xD;
&#xD;
          -  enrolled in a special education program at school (other than gifted program) that&#xD;
             would interfere with ability to master the material&#xD;
&#xD;
          -  have a condition that would preclude their participation in the dance activities of&#xD;
             the summer program&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrice G Saab, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Patricia and Phillip Museum of Science</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Hall of Science</name>
      <address>
        <city>Queens</city>
        <state>New York</state>
        <zip>11368</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>February 20, 2017</last_update_submitted>
  <last_update_submitted_qc>February 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Patrice G. Saab</investigator_full_name>
    <investigator_title>Principal Investigator; Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02187939
org study id: 20111081
secondary id: 5R25OD010525
nct id: NCT02187939
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: change in Health Knowledge
time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
description: 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.
measure: change in Self-efficacy - physical activity
time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
description: 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.
measure: change in Self-efficacy - fruit and vegetable consumption
time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
description: 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.
measure: change in Self-efficacy - science
time frame: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
description: Science self-efficacy assesses confidence to master the GROOVE program science components.
measure: change in health behaviors
time frame: pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
description: eating habits and physical activity habits
measure: 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
description: 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.
measure: 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
description: Assesses family and participant activities and habits and ratings of participant health and interests.
measure: change in Pedometer activity
time frame: Participants will be given a pedometer to wear during the 3 week summer program period
description: Pedometers will be used daily to assess physical activity.
measure: Change in eating behavior
time frame: Up to 4 assessments will occur over the 3 week program.
description: 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.
measure: change in Presence
time frame: up to 3 times during the GROOVE+ condition
description: 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.
arm group label: Summer wellness program - nutrition & physical activity
arm group type: Active Comparator
description: 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.
arm group label: Summer program plus virtual world technology
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.
description: 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.
arm group label: Summer program plus virtual world technology
arm group label: Summer wellness program - nutrition & physical activity
criteria: 
gender: Female
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrice G Saab, Ph.D.
role: Principal Investigator
affiliation: University of Miami
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Patrice G. Saab
investigator title: Principal Investigator; Professor