Get in the GROOVE!

Health Behavior Clinical Trial

— GROOVE  

Official title:

Get in the GROOVE (Girls Realizing Options Through OpenSim Virtual Experiences)!

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187939
• Other study ID #: 20111081
• Secondary ID: 5R25OD010525
• Status: Completed
• Phase: N/A
• First received: June 30, 2014
• Last updated: February 20, 2017
• Start date: May 2013
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: January 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Prevention Harmful Effects

Intervention

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.

Locations

Country	Name	City	State
United States	Patricia and Phillip Museum of Science	Miami	Florida
United States	New York Hall of Science	Queens	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of Miami	National Institutes of Health (NIH), New York Hall of Science, Patricia and Phillip Frost Museum of Science (formerly known as Miami Science Museum)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in health behaviors	eating habits and physical activity habits	pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
Other	change in Science attitudes and aspirations	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
Other	change in Family and participant habits	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
Other	change in Pedometer activity	Pedometers will be used daily to assess physical activity.	Participants will be given a pedometer to wear during the 3 week summer program period
Other	Change in eating behavior	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.
Other	change in Presence	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
Primary	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.	pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
Secondary	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.	pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
Secondary	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.	pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
Secondary	change in Self-efficacy - science	Science self-efficacy assesses confidence to master the GROOVE program science components.	pretreatment ( Day1-2) and post treatment (end of 3 week summer session)