- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01289145
Stage-based Exercise Promotion Study (STEPS)
The purpose of this study is to increase regular physical activity among students by fostering self-management competencies. The intervention was implemented as paper-pencil intervention. The aim of this research project is to evaluate a motivational and volitional intervention in comparison to a control intervention.
Study participants will be recruited in lectures at Freie Universitaet Berlin and followed up twice (two and ten weeks after baseline).
The motivational intervention is expected to increase unmotivated participants' intention to be physically active. The volitional intervention is expected to promote physical activity among motivated but inactive participants. Both interventions are hypothesized to improve self-management competencies over time.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
An experimental study is planned over a time period of ten weeks. In the physical activity study, participants will randomly be allocated to either one of two intervention groups (IG) or to an active control group (ACG), receiving a quiz on physical activity and sports. Intervention group 1 receives a paper-pencil intervention which focuses on positive outcome expectancies (motivational intervention). Intervention group 2 receives a paper-pencil intervention which promotes the formulation of action plans for physical activity (volitional intervention).
Furthermore, all participants will receive two emails as intervention boosters until the end of the study.
Study participants will be invited to take part in the study during lectures of the Freie Universitaet Berlin. The students will be followed up twice: two weeks after T1 (paper-pencil), T2 will take place (paper-pencil). Eight weeks after T2 the T3 assessment will be conducted online.
The hypotheses are:
Participants of the motivational intervention report a larger increase in motivation to adopt physical activity from T1 to T2 and T3, as compared to the participants of the volitional or the control intervention. Effects will be larger in unmotivated participants than in already motivated participants.
Participants of the volitional intervention report a larger increase in physical activity from T1 to T2 and T3, as compared to the participants of the motivational or the control intervention. Effects will be larger in motivated participants than in unmotivated participants.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Berlin, Tyskland, 14195
- Freie Universität Berlin
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- to be capable of exercising on their own at a minimum level
- able to fill out a questionnaire (no illiteracy)
- adequate German language ability
Exclusion Criteria:
- no internet access
- no email address
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
Participants will be allocated to a motivational intervention, a volitional intervention or the active control group. The motivational intervention promotes positive outcome expectancies on physical activity. The volitional intervention promotes the formulation of action plans for physical activity. Participants in the active control group, receive a quiz on physical activity and sports. |
The motivational intervention promotes positive outcome expectancies on physical activity.
The volitional intervention promotes the formulation of action plans for physical activity.
Participants receive a quiz on physical activity and sports.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported physical activity frequency and duration
Tidsramme: two months
|
Participants will be asked on how many days per week they were physically active and how much time they had spent on average performing these activities on each of these days (adapted version of the Godin scale)
|
two months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Algorithm for Stages of Change (SOC) based on behavior and intention
Tidsramme: two months
|
Participants will be asked if they already are physically active and if they want to be more physically active, using a validated staging algorithm.
|
two months
|
|
Social Cognition
Tidsramme: two months
|
We will assess social cognition based on a validated psychometric scale that is worded in a behavior-specific manner (physical activity) and has several subscales.
|
two months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Ralf Schwarzer, PhD, Freie Universität Berlin
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STEP-2011-PK
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Motivational intervention
-
University of MichiganNational Institute on Drug Abuse (NIDA)AfsluttetStofmisbrugForenede Stater
-
Penn Medicine Princeton HealthUkendtVægttabForenede Stater
-
University of MiamiAB InBev FoundationAfsluttet
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Johns Hopkins University; Thai Nguyen...AfsluttetAlkohol drikke | HIVVietnam
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health...Afsluttet
-
The Cleveland ClinicAmerican Academy of Sleep MedicineAfsluttetObstruktiv søvnapnø | Akut dekompenseret hjertesvigt | Motiverende forbedring | PAP OverholdelseForenede Stater
-
Cambridge Health AllianceUniversity of South Florida; Centers for Disease Control and PreventionAfsluttetAdfærdsmæssige symptomer | Opioidbrugsforstyrrelse | Psykiatriske eller humørsygdomme eller tilstandeForenede Stater
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetMisbrug af alkoholForenede Stater
-
UConn HealthNational Institute on Drug Abuse (NIDA)Afsluttet
-
Dartmouth-Hitchcock Medical CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Afsluttet