Accelerometer-linked Online Intervention to Promote Physical Activity in Adolescents
23. april 2015 oppdatert av: HopeLab Foundation
The primary objective of this protocol is to test whether an activity monitor with an online motivational rewards component will increase physical activity levels of middle school-aged students.
The secondary objective is to learn about the functionality and utilization of the activity meter device among this age group.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
The goal of this pilot study is to find out whether an activity meter linked to web-based rewards will increase physical activity levels in middle school aged students who use it over 6 weeks.
To test this, students who participate in the study will be assigned to 1 of 3 groups: the meter with web-based rewards group, the Dance Dance Revolution group, or the control group.
The physical activity of participants in all 3 groups will be tracked using the an activity meter that participants will be asked to carry daily for the 6 weeks of the study.
Participants given the activity meter with web-based rewards or Dance Dance Revolution will be instructed to use them at their own will, as much or as little as they like.
Before beginning the study, all participating students will be asked background questions about themselves (such as their gender, age, and ethnic group) and about the kinds of computer and video game consoles they have access to at home.
All participants will also complete short questionnaires at enrollment, week 1, week 3 and week 6.
These questions will ask participants about their experiences using the assigned devices, their physical activity levels, and their thoughts about their ability to be physically active.
At the end of 6 weeks, all participants will finish the study and return their assigned devices to the study coordinator.
Height and weight will be measured at baseline and at the end of the study.
Studietype
Intervensjonell
Registrering (Faktiske)
182
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
California
-
Mountain View, California, Forente stater, 94043
- Crittenden Middle School
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Vista, California, Forente stater, 92083
- Vista Middle School
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West Virginia
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Morgantown, West Virginia, Forente stater, 26506
- West Virginia University
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
11 år til 14 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Any student 11 to 14 years old with access to a computer that uses either Windows XP or Mac OS X 10.4 operating system with internet access.
Exclusion Criteria:
- Anyone with a medical condition or existing health complications that will interfere with their ability to be physically active.
- Inability to read and write English (though consent forms for parents that speak other languages will be provided).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention Group
This group is provided an activity meter that tracks the amount and intensity of one's physical activity and is linked to a motivational website.
On the website, activity data from the activity meter can be viewed after uploading information from the meter to the website.
The reward website allots points for participants based on the amount and intensity of physical activity.
Points can be redeemed for rewards on the website, such as gift cards and digital badges.
|
The activity meter linked to a motivational website is designed to motivate middle school-aged children to increase their rates of physical activity by providing feedback on the amount of activity, and rewards based on the amount and duration of activity.
|
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Aktiv komparator: Active Control
This group is provided an activity meter that tracks the amount and intensity of one's physical activity and a copy of the game Dance Dance Revolution (DDR).
The activity meter will upload data to a secure server but will not be linked to the motivational website used by the intervention group.
DDR is a dancing video game in which players view arrows timed to music on a TV screen and gain points by stepping on the corresponding arrows on a floor mat.
Players obtain points in the game by stepping on the correct arrows at the right time to the beat of the music.
The points earned with DDR cannot be redeemed for rewards.
|
The active video game, Dance Dance Revolution, requires physical movement as part of game play and may motivate users to engage in more activity.
The same activity meter used in the Intervention Group is provided to this group to track physical activity but does not link to the motivational website nor does it provide any feedback on levels or duration of activity.
|
|
Placebo komparator: Passive Control
This group is provided with an activity meter and will be asked to carry it with them as they go about their normal daily activities.
Like in the Active Control group, participants in the Passive Control group will not have access to the motivational website.
For this group, the activity meter functions solely as a monitor to track their activity levels.
No other product or intervention will be introduced to the control group.
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Participants are provided the same activity meter used in the other study groups to track physical activity but it does not link to the motivational website nor does it provide any feedback on levels or duration of activity.
Participants are asked to go about their normal activities.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical Activity
Tidsramme: 6 weeks
|
The amount and intensity of physical activity is recorded continuously every study day that participants wear the provided activity meter for the 6 weeks study.
The primary outcome reported will be rates of "moderate to vigorous" physical activity.
|
6 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Steven Cole, PhD, HopeLab Foundation
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2008
Primær fullføring (Faktiske)
1. juni 2009
Studiet fullført (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først innsendt
16. april 2015
Først innsendt som oppfylte QC-kriteriene
23. april 2015
Først lagt ut (Anslag)
24. april 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. april 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. april 2015
Sist bekreftet
1. april 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HL-GD001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .