- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01458002
Online Tailored Interventions & Relational Agents for Exercise and Sun Protection (Project RAISE)
10 maj 2016 uppdaterad av: Wayne F. Velicer, University of Rhode Island
This study targets two major risk factors for cancer; is designed to treat the behaviors on a population basis, using proactive recruitment strategies; intervenes on multiple behaviors simultaneously, thereby producing greater impacts for cancer prevention; utilizes one of the most promising approaches to low cost population based interventions for health-related behavior change, namely the internet; and develops and tests a promising new approach to increasing the utilization and effectiveness of internet-based interventions, relational agents.
The primary aims are: (1) To develop and assess the effectiveness of a tailored internet intervention on a national sample; (2) To develop and assess the effectiveness of the internet intervention enhanced by a relational agent; and (3) To determine if the intervention with the relational agent can outperform the regular tailored internet intervention.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The overarching goal of this research project is to revise and enhance a multimedia computer-based multiple risk factor intervention for cancer prevention, using the internet to reach a general population.
Two innovative, individualized, easily disseminated, low-cost, and interactive interventions, both for multiple behaviors (sun protection and exercise adoption), will be developed and evaluated in comparison to a control condition.
The first intervention involves adapting our effective multimedia expert system interventions to the internet environment.
The second intervention builds on the first with the additional inclusion of a Relational Agent, a recently developed computer-based approach to establishing a personal relationship typically missing on internet sites.
Both systems will employ the same theoretical model of behavior change, the Transtheoretical Model, as the deep knowledge, and all systems will employ empirically based decision rules.
The design is a 3 Group (Control, Internet, Internet plus Relational Agent) x 3 Occasions (0, 12, 24 • Months) with intervention occurring during the first 12 months.
A representative national sample of 1639 individuals at risk for both behaviors will be recruited.
The primary aims are: (1) To develop and assess the effectiveness of a tailored internet intervention on a national sample; (2) To develop and assess the effectiveness of the internet intervention enhanced by a relational agent; and (3) To determine if the intervention with the relational agent can outperform the regular tailored internet intervention.
The secondary aims are: (1) To determine if the two interventions are differentially effective with each behavior and with different subgroups, and (2) To determine if the relational agent intervention is utilized more often for increasing exercise than for sun protection.
This study targets two major risk factors for cancer; is designed to treat the behaviors on a population basis, using proactive recruitment strategies; intervenes on multiple behaviors simultaneously, thereby producing greater impacts for cancer prevention; utilizes one of the most promising approaches to low cost population based interventions for health-related behavior change, namely the internet; and develops and tests a promising new approach to increasing the utilization and effectiveness of internet-based interventions, relational agents.
Studietyp
Interventionell
Inskrivning (Faktisk)
1364
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Rhode Island
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Kingston, Rhode Island, Förenta staterna, 02881
- University of Rhode Island
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- English speaking
- access to computer
- willing to download materials
Exclusion Criteria:
- heart attack in past 6 months
- kidney failure during dialysis
- currently receiving chemotherapy or radiation for cancer
- had a seizure in the past 6 months
- had a leg or pelvic fracture in the past 6 months
- legally blind
- regularly use a wheelchair
- (women only) currently pregnant or plan to be pregnant in the next 6 months
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontrollera
Endast bedömning
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Övrig: Tailored Internet Communications
TTM expert system only
|
The Tailored Internet Intervention will include a "relational agent" component, which is an animated conversational agent that builds a working relationship with subjects over time and uses this alliance to boost intervention effectiveness and retention to the Tailored Internet Communications web site.
Best practices for TTM tailored communications with two types of feedback: normative - compared to peers and ipsative - self compared to previous assessment.
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Experimentell: Tailored Internet Communication with Relational Agent
TTM expert system plus relational agent
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The Tailored Internet Intervention will include a "relational agent" component, which is an animated conversational agent that builds a working relationship with subjects over time and uses this alliance to boost intervention effectiveness and retention to the Tailored Internet Communications web site.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exercise
Tidsram: Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months.
|
Regular Exercise is defined as any planned physical activity (e.g., brisk walking, aerobics, jogging, bicycling, swimming, rowing, basketball, etc.) performed to increase physical fitness.
Such activity should be performed 5 times or more per week for 30 minutes per session, consistent with CDC guidelines.
|
Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months.
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Sun Exposure
Tidsram: Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months
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Consistently protecting themselves from the sun every time they were out in the sun for 15+ minutes is defined as 1) using sunscreens with a sun protection factor (SPF) of 15 or more, wearing protective clothing (for example, a hat with a wide brim, shirts, and pants), and avoiding or limiting exposure to the sun during the mid-day hours (10 am - 4 pm).
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Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Exercise
Tidsram: Increase in number of minutes of physical activity per week (150 minutes of moderate intensity or 75 minutes of vigorous intensity) measured by the International Physical Activity Questionnaire (IPAT)
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Increase in number of minutes of physical activity per week (150 minutes of moderate intensity or 75 minutes of vigorous intensity) measured by the International Physical Activity Questionnaire (IPAT)
|
|
Sun Exposure
Tidsram: Increase in number of sun protection behaviors as measured by the Sun Protection Behavior Scale (SPBS), which consists of three scales: sunscreen use, sun avoidance and protective clothing, and hat use.
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Increase in number of sun protection behaviors as measured by the Sun Protection Behavior Scale (SPBS), which consists of three scales: sunscreen use, sun avoidance and protective clothing, and hat use.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Wayne F Velicer, PhD, Univeristy of Rhode Island
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2009
Primärt slutförande (Faktisk)
1 maj 2013
Avslutad studie (Faktisk)
1 maj 2013
Studieregistreringsdatum
Först inskickad
20 september 2011
Först inskickad som uppfyllde QC-kriterierna
20 oktober 2011
Första postat (Uppskatta)
24 oktober 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
12 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 maj 2016
Senast verifierad
1 maj 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CA119195
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
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