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 web-based intervention to improve PA and dietary behaviors in overweight (BMI 25-34.9) men age 18 through 55 years. PACEi has three integrated components: a) preclinic-visit web-based assessment and progress planner; b) provider counseling; c) 12 months of web-based, e-mail & limited phone contact. Pilot study results demonstrate that a phone & mail-based version of PACEi has promise in improving dietary & PA behaviors. An NCI-funded randomized, controlled trial of PACEi among overweight women is currently underway. Phase 1 will involve formative research to structure PACEi to the unique needs of men and their physicians. In Phase 2 we will recruit 360 overweight men seen in 4 healthcare settings. Subjects will be randomly assigned to PACEi or a usual care, delayed treatment control condition. PACEi targets 3 primary and 3secondary behaviors: Primary: a) energy expenditure from moderate and vigorous physical activity during leisure-time; b) fruit & vegetable servings; c) dietary saturated fat as percent of energy consumed. Secondary: a) fiber intake; b) total energy intake; c) total dietary fat as a percent of energy consumed. PACEi also assesses stage of change and psychosocial mediators of behavior change. The PACEi approach guides patients to select one dietary and one PA target behavior for which they develop action plans to discuss with the provider. The provider endorses or modifies the action plan and encourages participation in the continued intervention. Web-tutorials, continuous web access, e-mail interaction, and phone counseling every three months guide the patient to use cognitive & behavioral skills to change target behaviors. The program enables participants to receive tailored & stage-appropriate interventions to address their diet & PA goals. Primary outcomes ((a) energy expended in moderate and vigorous physical activity during leisure; (b) servings of fruits and vegetables; and (c) dietary saturated fat as a percent of energy consumed) will be assessed at baseline and 12 months with the International Physical Activity Questionnaire (IPAQ) and a food frequency questionnaire developed for men at the Fred Hutchinson Cancer Research Center. Secondary outcomes and mediators of behavior change will be measured at baseline, 6, 12 and 24 months. Secondary & exploratory outcomes include: objective and self-report measures of PA, recreational media use & dietary behaviors (fiber; total energy intake; fat intake as a percent of total energy consumed); and BMI, skinfolds, waist circumference, body composition, and psychosocial mediators of change. The PACE+ intervention is particularly innovative because its three components - pre-visit web assessment, primary care provider counseling, and the extended web-based intervention - are unified through a common behavioral theoretical framework.
