- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Florida
-
Miami, Florida, Spojené státy, 33129
- Patricia and Phillip Museum of Science
-
-
New York
-
Queens, New York, Spojené státy, 11368
- New York Hall of Science
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
change in Health Knowledge
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
change in Self-efficacy - physical activity
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
change in health behaviors
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Patrice G Saab, Ph.D., University of Miami
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 20111081
- 5R25OD010525 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Prevence škodlivých účinků
-
PepsiCo Global R&DDokončenoDovednostní výkon | Fotbalový výkon | Coffeeberry EffectsSpojené království
-
PepsiCo Global R&DDokončenoDovednostní výkon | Fotbalový výkon | Coffeeberry EffectsSpojené království
-
The Hong Kong Polytechnic UniversityNáborElektroencefalografie | Transkraniální stimulace stejnosměrným proudem | Porucha autistického spektra | Booster EffectsHongkong