Skip to main content
OpenTrials
Completed

NCT Number: NCT01657422

PACE+: Counseling Adolescents for Exercise and Nutrition

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, La Jolla, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PACE+

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

Other names: PACE+ Intervention

Primary outcomes

  1. Dietary fat, fruits & vegetable consumption

    Time frame: 12months

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

  2. Physical activity

    Time frame: 12 months

    Equal in importance to the other two primary outcome measures, dietary fat, fruits and vegetables, and sedentary behaviors

  3. sedentary behavior

    Time frame: 12 months

    equal in importance to the other two primary outcome measures: physical activity and diet fat, fruits and vegetable consumption

Secondary outcomes

  1. dietary fat, fruits and vegetables

    Time frame: 24 months

    All were equal in terms of importance

  2. physical activity

    Time frame: 24 months

  3. sedentary behavior

    Time frame: 24 months

Other outcomes

  1. weight status

    Time frame: 12 and 24 months

    Both time points equally important

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • San Diego State University

Registry information

Acronym: PACEAdol

Important dates

Study start
2000
Primary completion
2004
Study completion
2006
First posted
Aug 6, 2012
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.