Helping Women Adopt a Cancer Prevention Diet

描述（由申请人提供）：本研究将评估两种干预策略对饮食改变的影响，一种使用面对面的个人咨询，另一种使用自动的、基于计算机的干预。这些干预措施的目标将是相同的：采用一种预防癌症的饮食，即多吃水果和蔬菜，不超过适度的脂肪消耗。基于我们之前的研究，这些干预措施将在600名女性HMO成员的2x2随机临床试验中进行评估。在本设计中，四分之一的参与者将接受面对面干预，四分之一的参与者将接受自动（计算机化）干预，四分之一的参与者将接受面对面和自动干预相结合的干预，四分之一的参与者将接受与饮食改变无关的注意力控制干预。饮食目标将是5-9份水果和蔬菜，脂肪的能量低于25%。2（有或没有面对面咨询）× 2（有或没有自动咨询）设计将使用广义估计方程方法来评估主要和次要结果。参与者将是600名健康女性，通过她们的初级保健医生招募她们参加这项研究。RE-AIM框架将用于评估这些干预措施的覆盖范围和有效性，并着眼于在管理式医疗环境中随后的采用、实施和维护。在3个月、12个月和18个月的随访中，主要的结果测量将是自我报告的每日水果和蔬菜摄入量的变化，以及脂肪能量的百分比。次要结果测量将包括血清类胡萝卜素的变化和参与者满意度和抑郁的测量。这项研究将允许彻底调查基于计算机的咨询与面对面咨询在降低癌症风险方面的优缺点。

DESCRIPTION (provided by applicant): This study will evaluate the impact of two intervention strategies for dietary change, one using in-person individual counseling and the other using an automated, computer-based intervention. The goals of these interventions will be the same: adoption of a cancer prevention diet that is high in fruits and vegetables and with no more than moderate fat consumption. Based on our previous research, these interventions will be evaluated in a 2x2 randomized clinical trial with 600 female HMO members. In this design, one-quarter of the participants will receive the face-to-face intervention, one-quarter the automated (computerized) intervention, one-quarter the combination of the in-person and automated intervention, and one-quarter will receive an attention control intervention unrelated to dietary change. Dietary goals will be 5-9 servings of fruits and vegetables and <25percent of energy from fat. A 2 (presence or absence of in-person counseling) x 2 (presence or absence of automated counseling) design will be used to evaluate primary and secondary outcomes using generalized estimating equation methods. Participants will be 600 healthy women recruited to the study through their primary care physicians. The RE-AIM framework will be used to evaluate these interventions on Reach and Efficacy, with an eye to later Adoption, Implementation, and Maintenance in a managed care setting. The primary outcome measures at 3-, 12-, and 18-month follow-ups will be change in self-reported daily servings of fruits and vegetables, and percent of energy from fat. Secondary outcome measures will include change in serum carotenoids and measures of participant satisfaction and depression. This study will permit a thorough investigation of the strengths and weaknesses of computer-based counseling compared to in-person counseling to reduce cancer risk.