PACE+: Counseling Adolescents for Exercise and Nutrition (PACEAdol)

University of California San Diego

Status: Completed

Conditions: Physical Activity; Dietary Modification

Treatments: Behavioral: PACE+

Study type: Interventional

Funder types: Other

Identifiers

NCT01657422

7R01CA081495-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 819 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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819 participants in 2 patient groups

PACE+ Intervention

Experimental group

Description:

Intervention Group

Treatment:

Behavioral: PACE+

Sun Protection

No Intervention group

Description:

Control / Comparison group. Patients assigned to the comparison group will receive intervention strategies over a the course of 2 years including: (1) completion of a 30-minute office-based computer program resulting in on-screen feedback to address excess sun exposure prevention, and (2) 4 phone calls and 4 mailings over a 24-month period conducted by PACE+ staff members.