Online Tailored Interventions & Relational Agents for Exercise and Sun Protection

NCT ID: NCT01458002

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1364 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Sedentary Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Assessment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Tailored Internet Communications

TTM expert system only

Group Type OTHER

Tailored Internet Communication with Relational Agent

Intervention Type OTHER

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.

Tailored Internet Communications

Intervention Type OTHER

Best practices for TTM tailored communications with two types of feedback: normative - compared to peers and ipsative - self compared to previous assessment.

Tailored Internet Communication with Relational Agent

TTM expert system plus relational agent

Group Type EXPERIMENTAL

Tailored Internet Communication with Relational Agent

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northeastern University

OTHER

Sponsor Role collaborator

Pro-Change Behavior Systems

OTHER

Sponsor Role collaborator

University of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Wayne F. Velicer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wayne F Velicer, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Rhode Island

Locations

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University of Rhode Island

Kingston, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21449711 (View on PubMed)

Other Identifiers

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CA119195

Identifier Type: -

Identifier Source: org_study_id

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