Clinical trial NCT01458002: Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
Official title: Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary
Skin Cancer
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: Pro-Change Behavior Systems
First posted: 2011-10-24
Enrollment: 1364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Exercise
timeFrame: Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months.
measure: Sun Exposure
timeFrame: Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months
Secondary outcomes:
measure: Exercise
timeFrame: 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)
measure: Sun Exposure
timeFrame: 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.
Other outcomes:
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
affiliation: Univeristy of Rhode Island
name: Wayne F Velicer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.