Trial Information

PACE+: Counseling Adolescents for Exercise and Nutrition

Improved physical activity (PA) and nutrition behaviors in adolescents show great promise to
reduce risk of cancers and other diseases. Fewer than 20% of adolescents meet
recommendations for fat or fruits & vegetables consumption, and only 50% of adolescent girls
and 67% of boys meet recommendations for vigorous PA. PACE+ will evaluate an integrated
clinical and home-based intervention to improve physical activity (PA) and nutrition
behaviors in adolescents. The intervention has three integrated components: a computer
assessment and action planner; provider counseling; and 24 months of extended phone & mail
contact. 768 male and female adolescents age 11 through 15; will be recruited from six
healthcare settings. Subjects will be randomly assigned within practices to two successive
one-year "doses" of PACE+ or a comparison condition involving counseling for sun protection
behaviors. PACE+ assesses four behaviors: 1) dietary fat, 2) fruits & vegetable consumption,
3) physical activity, and 4) sedentary behavior. Primary behavioral outcomes, secondary
outcomes, and selected mediators and process variables will be measured prior to the first
office visit and at 6, 12 and 24 months. Primary outcomes will be measured by the 7-day
physical activity recall and 3-day food record of fruits & vegetables and fat at 12 months.
Secondary outcomes include adiposity, fitness, BMI, psychosocial mediators of change, and
body image. Potential risks are psychological and physical, however the risks are slight and
of low likelihood. Benefits include helping bring about healthier lifestyles to prevent
weight gain and reduce premature morbidity and mortality due to cancer, cardiovascular
disease and other health problems. This study will be the first to evaluate a combined
physical activity and nutrition intervention for youth that revolves around the primary
health care setting.