SedentaryProject RAISENCT01458002
Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
A study testing Tailored Internet Communication with Relational Agent and Tailored Internet Communications in people with Sedentary and Skin Cancer, run by University of Rhode Island at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary, Skin Cancer
- What is being tested?
- Tailored Internet Communication with Relational Agent and Tailored Internet Communications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,364 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- access to computer
- willing to download materials
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rhode Island
Kingston, Rhode Island, 02881
About this study
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.
Read the 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.
- Conditions
- Sedentary, Skin Cancer
- Being tested
- Tailored Internet Communication with Relational Agent, Tailored Internet Communications
- Medical subject headings
- Sedentary Behavior, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Internet Communication with Relational AgentOther
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 CommunicationsOther
Best practices for TTM tailored communications with two types of feedback: normative - compared to peers and ipsative - self compared to previous assessment.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Assessment only |
| Tailored Internet Communications | Other | TTM expert system only Receives: Other: Tailored Internet Communication with Relational Agent; Other: Tailored Internet Communications |
| Tailored Internet Communication with Relational Agent | Experimental | TTM expert system plus relational agent Receives: Other: Tailored Internet Communication with Relational Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Percentage of baseline at-risk participants who reach the Sun Protection criteria at 24 months
Secondary outcomes (2)
Exercise
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startApr 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedentaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,364 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, Pro-Change Behavior Systems
- Responsible party
- Principal investigator, Wayne F. Velicer, University of Rhode Island
- Investigators
- Wayne F Velicer, PhD, Principal investigator, Univeristy of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458002
- Sponsor's protocol ID
- CA119195
- Acronym
- Project RAISE
- Status last verified
- May 2016
- First submitted
- 20 Sep 2011
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21449711
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Tailored Interventions & Relational Agents for Exercise and Sun Protection
- ClinicalTrials.gov ID
- NCT01458002
- Acronym / sponsor ID
- Project RAISE / CA119195
- Conditions
- Sedentary, Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,364 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- Northeastern University, Pro-Change Behavior Systems
- Study start
- Apr 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Assessment only |
| Tailored Internet Communications | Other | Other: Tailored Internet Communication with Relational Agent, Other: Tailored Internet CommunicationsTTM expert system only |
| Tailored Internet Communication with Relational Agent | Experimental | Other: Tailored Internet Communication with Relational AgentTTM expert system plus relational agent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- access to computer
- willing to download materials
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Internet Communication with Relational AgentThe 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 Communication with Relational Agent, Tailored Internet Communications |
| Tailored Internet CommunicationsBest practices for TTM tailored communications with two types of feedback: normative - compared to peers and ipsative - self compared to previous assessment. | Other | Tailored Internet Communications |
Primary outcome
Exercise
Time frame: Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months.
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
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).
2 secondary outcomes
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 21449711Redding 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne F Velicer, PhD principal investigator
Univeristy of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Internet Communication with Relational Agent and Tailored Internet Communications in people with Sedentary and Skin Cancer, run by University of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise (time frame: Percentage of baseline at-risk participants who reach the Regular Exercise criteria at 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01458002, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.