|Grant Number:||5R01CA085873-05 Interpret this number|
|Primary Investigator:||Patrick, Kevin|
|Organization:||University Of California San Diego|
|Project Title:||Counseling for Overweight Women for Diet and Activity|
Improved physical activity (PA) and dietary behaviors show great promise to reduce risk of cancers, CVD, NIDDM and other diseases. Improvements in PA and nutrition are particularly important for the overweight, a condition now affecting more than 50 percent of Americans. There are few effective programs for treating overweight in primary care. In this project we will evaluate an integrated clinical and home- based intervention to improve PA and dietary behaviors in overweight (BMI 25-29.9) women. PACE+ has three integrated components, a computer assessment and action planner, provider counseling; and 12 months of extended phone and mail contact. Pilot study results (n=173) demonstrate that PACE+ shows substantial promise in improving dietary and PA behaviors We will recruit 360 overweight women age 18 to 45 seen in 4 healthcare settings. Subjects will be randomly assigned to PACE+ or a usual care, delayed treatment control comparison condition. PACE+ targets three primary and three secondary behaviors: Primary: a) dietary quality (fruits and vegetables, vitamin C, carotenoids, and fiber); b) total dietary fat as a percent of energy consumed; and c) energy expenditure from moderate and vigorous physical activity during leisure-time. Secondary: a) recreational media use; b) overeating; c) saturated fat as percent of energy consumed. PACE+ also assesses stage of change and psychosocial mediators of behavior change. The PACE+ computer program guides patients to select one dietary and one PA target behavior for which they develop action or maintenance plans to discuss with the provider. The provider endorses or modifies the action plan and encourages participation in the extended phone and mail intervention. Phone counseling, mail and print materials guide the patient to use cognitive and behavioral skills to make changes in target behaviors. At six months subjects are reassessed over the phone and then continue to receive stage-appropriate intervention to address their new diet and PA goals. Primary outcomes ((a) a combined measure of energy expended in moderate and vigorous physical activity during leisure; ) an index of dietary quality encompassing increased fruits and vegetables and nutrient indicators of these foods; and (c) total dietary fat as a percent of energy consumed) will be assessed at baseline and 12 months with 7-day PA recall and food frequency questionnaires. Secondary outcomes and mediators of behavior change will be measured at baseline, 6, 12 and 24 months. Secondary outcomes include objective and self-report measures of PA and recreational media use and self-reported dietary behaviors (overeating; saturated fat intake as a percent of total energy consumed), BMI, skinfolds, waist circumference, psychosocial mediators of change. Exploratory assessment of plasma carotenoids and 24-hour dietary recall will be performed on a sub-sample of subjects to validate self report measures. The PACE+ intervention is particularly innovative in that three components - computer, primary care provider counseling, and an extended home-based intervention - are unified through a common theoretical framework.