- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02425384
Accelerometer-linked Online Intervention to Promote Physical Activity in Adolescents
23 april 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
182
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
California
-
Mountain View, California, Verenigde Staten, 94043
- Crittenden Middle School
-
Vista, California, Verenigde Staten, 92083
- Vista Middle School
-
-
West Virginia
-
Morgantown, West Virginia, Verenigde Staten, 26506
- West Virginia University
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
11 jaar tot 14 jaar (Kind)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Actieve vergelijker: 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-vergelijker: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Physical Activity
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Steven Cole, PhD, HopeLab Foundation
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2008
Primaire voltooiing (Werkelijk)
1 juni 2009
Studie voltooiing (Werkelijk)
1 juni 2009
Studieregistratiedata
Eerst ingediend
16 april 2015
Eerst ingediend dat voldeed aan de QC-criteria
23 april 2015
Eerst geplaatst (Schatting)
24 april 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
24 april 2015
Laatste update ingediend die voldeed aan QC-criteria
23 april 2015
Laatst geverifieerd
1 april 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- HL-GD001
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .