Clinical trial NCT01657422: PACE+: Counseling Adolescents for Exercise and Nutrition
Official title: PACE+: Counseling Adolescents for Exercise and Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Physical Activity
Keywords: Nutrition
Physical Activity
Adolescents
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2012-08-06
Enrollment: 819
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects must be in good general health and have the ability to read and speak English.

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).

Primary outcomes:
measure: Dietary fat, fruits & vegetable consumption
timeFrame: 12months
measure: Physical activity
timeFrame: 12 months
measure: sedentary behavior
timeFrame: 12 months
Secondary outcomes:
measure: dietary fat, fruits and vegetables
timeFrame: 24 months
measure: physical activity
timeFrame: 24 months
measure: sedentary behavior
timeFrame: 24 months
Other outcomes:
measure: weight status
timeFrame: 12 and 24 months
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: San Diego State University Foundation
state: California
Study officials:
affiliation: UCSD
name: Kevin Patrick, MD
role: PRINCIPAL_INVESTIGATOR
References: