PACE+: Counseling Adolescents for Exercise and Nutrition

NCT ID: NCT01657422

Last Updated: 2012-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 819 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-31
• Study Completion Date: 2006-04-30

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.

Conditions

Dietary Modification; Physical Activity

Keywords

Nutrition; Physical Activity; Adolescents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PACE+ Intervention

Intervention Group

Group Type: EXPERIMENTAL

PACE+

Intervention Type: BEHAVIORAL

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

Sun Protection

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PACE+

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

Intervention Type: BEHAVIORAL

Other Intervention Names

PACE+ Intervention

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).

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Diego State University

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Kevin Patrick, MD, MS

Kevin Patrick, MD, MS, Principal Investigaor and Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Patrick, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

University of California, San Diego

La Jolla, California, United States

San Diego State University Foundation

San Diego, California, United States

Countries

United States

Other Identifiers

7R01CA081495-04

Identifier Type: NIH

Identifier Source: org_study_id

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