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PACE+: Counseling Adolescents for Exercise and Nutrition

11 Years
15 Years
Not Enrolling
Dietary Modification, Physical Activity

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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.

Inclusion Criteria:

- Subjects must be in good general health and have the ability to read and speak

Exclusion Criteria:

- A known eating disorder,

- pregnancy,

- any cardiovascular or musculoskeletal problems that would limit their ability to
comply with physical activity recommendations, and

- being in foster care (due to difficulty in obtaining follow-up measures).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Dietary fat, fruits & vegetable consumption

Outcome Description:

Equal in importance to the other two primary outcome measures, physical activity and sedentary behaviors

Outcome Time Frame:


Safety Issue:


Principal Investigator

Kevin Patrick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Institutional Review Board

Study ID:




Start Date:

August 2000

Completion Date:

April 2006

Related Keywords:

  • Dietary Modification
  • Physical Activity
  • Nutrition
  • Physical Activity
  • Adolescents
  • Food Habits



University of California, San DiegoLa Jolla, California  92037-1709
San Diego State University FoundationSan Diego, California  92128