Online Tailored Interventions & Relational Agents for Exercise and Sun Protection (Project RAISE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University of Rhode Island.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Northeastern University
Pro-Change Behavior Systems
Information provided by (Responsible Party):
Wayne F. Velicer, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01458002
First received: September 20, 2011
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Sedentary
Skin Cancer
Other: Tailored Internet Communication with Relational Agent
Other: Tailored Internet Communications

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Online Tailored Interventions & Relational Agents for Exercise and Sun Protection

Resource links provided by NLM:


Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • Exercise [ Time Frame: Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 1360
Study Start Date: April 2009
Estimated Study Completion Date: September 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Assessment only
Tailored Internet Communications
TTM expert system only
Other: Tailored Internet Communication with Relational Agent
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.
Other: Tailored Internet Communications
Best practices for TTM tailored communications with two types of feedback: normative - compared to peers and ipsative - self compared to previous assessment.
Experimental: Tailored Internet Communication with Relational Agent
TTM expert system plus relational agent
Other: Tailored Internet Communication with Relational Agent
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458002

Locations
United States, Rhode Island
University of Rhode Island
Kingston, Rhode Island, United States, 02881
Sponsors and Collaborators
University of Rhode Island
Northeastern University
Pro-Change Behavior Systems
Investigators
Principal Investigator: Wayne F Velicer, PhD Univeristy of Rhode Island