PACE+: Counseling Adolescents for Exercise and Nutrition
Condition: Dietary Modification; Physical Activity
Study type: Interventional

Summary: 
      PACE+ was developed to address the increased number of adolescents in our country that are at
      risk for cardiovascular disease, cancer, and other diseases due to inactivity, obesity, and
      malnourishment. PACE+ will evaluate the efficacy of an integrated clinical and home-based
      intervention to improve physical activity and nutrition behaviors in adolescents ages 11-15
      over a period of 2 years.

      This study is unique in that it will be one of the first to evaluate a combined physical
      activity and nutrition intervention for youth that revolves around the primary health care
      setting. The PACE+ intervention is particularly innovative in that three components -
      computer, provider counseling, and an extended home-based intervention - are unified through
      a common theoretical framework.
    

Detailed description: 
      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.
    

Intervention name(s): PACE+
Intervention type(s): Behavioral
Intervention description(s): Patients assigned to the intervention group will receive intervention strategies over a the course of 2 years including: (1) completion of a 45-minute office-based computer program resulting in an assessment and action plan for improvement in physical activity and nutrition behaviors; (2) a provider counseling session immediately following the computerized assessment, followed by (3) 12 phone calls and 24 mailings over a 24-month period conducted by PACE+ staff members
Other intervention name(s): PACE+ Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition; Physical Activity; Adolescents