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

This study has been completed.
Sponsor:
Collaborator:
San Diego State University
Information provided by (Responsible Party):
Kevin Patrick, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01657422
First received: July 27, 2012
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Dietary Modification
Physical Activity
 Behavioral: PACE+

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PACE+: Counseling Adolescents for Exercise and Nutrition

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Dietary fat, fruits & vegetable consumption [ Time Frame: 12months ] [ Designated as safety issue: No ]
    Equal in importance to the other two primary outcome measures, physical activity and sedentary behaviors

  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Equal in importance to the other two primary outcome measures, dietary fat, fruits and vegetables, and sedentary behaviors

  • sedentary behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    equal in importance to the other two primary outcome measures: physical activity and diet fat, fruits and vegetable consumption


Secondary Outcome Measures:
  • dietary fat, fruits and vegetables [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    All were equal in terms of importance

  • physical activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • sedentary behavior [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • weight status [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Both time points equally important


Enrollment: 819
Study Start Date: August 2000
Study Completion Date: April 2006
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PACE+ Intervention
Intervention Group
 Behavioral: 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
Other Name: PACE+ Intervention
No Intervention: 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.

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

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657422

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
San Diego State University Foundation
San Diego, California, United States, 92128
Sponsors and Collaborators
University of California, San Diego
San Diego State University
Investigators
Principal Investigator: Kevin Patrick, MD UCSD
  More Information

No publications provided

Responsible Party: Kevin Patrick, MD, MS, Kevin Patrick, MD, MS, Principal Investigaor and Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01657422     History of Changes
Other Study ID Numbers: 7R01CA081495-04
Study First Received: July 27, 2012
Last Updated: August 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Nutrition
Physical Activity
Adolescents

Additional relevant MeSH terms:
Food Habits
Habits

ClinicalTrials.gov processed this record on May 16, 2013