Online Tailored Interventions & Relational Agents for Exercise and Sun Protection (Project RAISE)
Primary Purpose
Sedentary, Skin Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Internet Communication with Relational Agent
Tailored Internet Communications
Sponsored by
About this trial
This is an interventional prevention trial for Sedentary
Eligibility Criteria
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
Sites / Locations
- University of Rhode Island
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Other
Experimental
Arm Label
Control
Tailored Internet Communications
Tailored Internet Communication with Relational Agent
Arm Description
Assessment only
TTM expert system only
TTM expert system plus relational agent
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Exercise
Sun Exposure
Full Information
NCT ID
NCT01458002
First Posted
September 20, 2011
Last Updated
May 10, 2016
Sponsor
University of Rhode Island
Collaborators
Northeastern University, Pro-Change Behavior Systems
1. Study Identification
Unique Protocol Identification Number
NCT01458002
Brief Title
Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
Acronym
Project RAISE
Official Title
Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rhode Island
Collaborators
Northeastern University, Pro-Change Behavior Systems
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedentary, Skin Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1364 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Assessment only
Arm Title
Tailored Internet Communications
Arm Type
Other
Arm Description
TTM expert system only
Arm Title
Tailored Internet Communication with Relational Agent
Arm Type
Experimental
Arm Description
TTM expert system plus relational agent
Intervention Type
Other
Intervention Name(s)
Tailored Internet Communication with Relational Agent
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tailored Internet Communications
Intervention Description
Best practices for TTM tailored communications with two types of feedback: normative - compared to peers and ipsative - self compared to previous assessment.
Primary Outcome Measure Information:
Title
Exercise
Description
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.
Time Frame
Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months.
Title
Sun Exposure
Description
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).
Time Frame
Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months
Secondary Outcome Measure Information:
Title
Exercise
Time Frame
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)
Title
Sun Exposure
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne F Velicer, PhD
Organizational Affiliation
Univeristy of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rhode Island
City
Kingston
State/Province
Rhode Island
ZIP/Postal Code
02881
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21449711
Citation
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.
Results Reference
background
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Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
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