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临床试验/NCT01458002
NCT01458002已完成不适用

Online Tailored Interventions & Relational Agents for Exercise and Sun Protection

University of Rhode Island1 个研究点 分布在 1 个国家目标入组 1,364 人开始时间: 2009年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,364
试验地点
1
主要终点
Exercise

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •English speaking
  • •access to computer
  • •willing to download materials

排除标准

  • •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

研究组 & 干预措施

Control

No Intervention

Assessment only

Tailored Internet Communications

Other

TTM expert system only

干预措施: Tailored Internet Communication with Relational Agent (Other)

Tailored Internet Communications

Other

TTM expert system only

干预措施: Tailored Internet Communications (Other)

Tailored Internet Communication with Relational Agent

Experimental

TTM expert system plus relational agent

干预措施: Tailored Internet Communication with Relational Agent (Other)

结局指标

主要结局

Exercise

时间窗: 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

时间窗: 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).

次要结局

  • Exercise(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(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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wayne F. Velicer

Professor

University of Rhode Island

研究点 (1)

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