|Grant Number:||5R01CA098496-05 Interpret this number|
|Primary Investigator:||Stevens, Victor|
|Organization:||Kaiser Foundation Research Institute|
|Project Title:||Helping Women Adopt a Cancer Prevention Diet|
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.