- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Miami, Florida, Estados Unidos, 33129
- Patricia and Phillip Museum of Science
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New York
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Queens, New York, Estados Unidos, 11368
- New York Hall of Science
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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change in Health Knowledge
Periodo de tiempo: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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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.
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pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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change in Self-efficacy - physical activity
Periodo de tiempo: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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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.
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pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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change in Self-efficacy - fruit and vegetable consumption
Periodo de tiempo: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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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.
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pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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change in Self-efficacy - science
Periodo de tiempo: pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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Science self-efficacy assesses confidence to master the GROOVE program science components.
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pretreatment ( Day1-2) and post treatment (end of 3 week summer session)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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change in health behaviors
Periodo de tiempo: pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
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eating habits and physical activity habits
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pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
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change in Science attitudes and aspirations
Periodo de tiempo: pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
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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.
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pretreatment ( Day1-2), post treatment (end of 3 week summer session), and up to a year follow-up
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change in Family and participant habits
Periodo de tiempo: pretreatment ( Day1-2), post treatment (end of 3 week summer session - for participant only), and up to a year follow-up
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Assesses family and participant activities and habits and ratings of participant health and interests.
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pretreatment ( Day1-2), post treatment (end of 3 week summer session - for participant only), and up to a year follow-up
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change in Pedometer activity
Periodo de tiempo: Participants will be given a pedometer to wear during the 3 week summer program period
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Pedometers will be used daily to assess physical activity.
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Participants will be given a pedometer to wear during the 3 week summer program period
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Change in eating behavior
Periodo de tiempo: Up to 4 assessments will occur over the 3 week program.
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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.
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Up to 4 assessments will occur over the 3 week program.
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change in Presence
Periodo de tiempo: up to 3 times during the GROOVE+ condition
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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.
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up to 3 times during the GROOVE+ condition
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Patrice G Saab, Ph.D., University of Miami
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 20111081
- 5R25OD010525 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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