Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
Project RAISE
1 other identifier
interventional
1,364
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 12, 2016
May 1, 2016
4.1 years
September 20, 2011
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Exercise
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.
Sun Exposure
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).
Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months
Secondary Outcomes (2)
Exercise
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
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.
Study Arms (3)
Control
NO INTERVENTIONAssessment only
Tailored Internet Communications
OTHERTTM expert system only
Tailored Internet Communication with Relational Agent
EXPERIMENTALTTM expert system plus relational agent
Interventions
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.
Eligibility Criteria
You may qualify if:
- English speaking
- access to computer
- willing to download materials
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rhode Islandlead
- Northeastern Universitycollaborator
- Pro-Change Behavior Systemscollaborator
Study Sites (1)
University of Rhode Island
Kingston, Rhode Island, 02881, United States
Related Publications (1)
Redding CA, Prochaska JO, Paiva A, Rossi JS, Velicer W, Blissmer BJ, Greene GW, Robbins ML, Sun X. Baseline stage, severity, and effort effects differentiate stable smokers from maintainers and relapsers. Subst Use Misuse. 2011;46(13):1664-74. doi: 10.3109/10826084.2011.565853. Epub 2011 Mar 30.
PMID: 21449711BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne F Velicer, PhD
Univeristy of Rhode Island
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 20, 2011
First Posted
October 24, 2011
Study Start
April 1, 2009
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
May 12, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share