We propose a randomized controlled trial to evaluate """"""""PACE-Primary Care"""""""" (PACE-PC), a theory-based topped care program that enables pediatricians and other primary care providers to intervene with obese adolescents to improve their anthropometric, metabolic, physiological, behavioral, and quality of life outcomes. In the US, some 15% of adolescents are now obese. However, there are no evidence-based and lost-effective programs that primary care practitioners can use to treat these children. Study participants will be 110 adolescents age 11-13 years, obese (>95% BMI), and recruited through three large pediatric practices in the South Bay area of San Diego. The PACE-PC stepped care process incorporates recognized guidelines for treatment of obesity in children (Barlow &Dietz, 1998). It integrates clinician counseling, health educator counseling, and phone and mail (or web depending on access and preference) contact tailored to the needs of the om Year 1 can be maintained following the first intervention year, participants will enroll in a less intensive second """"""""Maintenance Year"""""""" of PACE-PC consisting of phone, mail (or web) and every other month group meetings. Participants randomized to the comparison """"""""enhanced standard care"""""""" condition will receive the community standard of care for obese adolescents consisting of an initial session with the pediatrician and 3 visits with a health counselor to discuss how to improve weight related behaviors. The primary aim of this study is to compare at 12 months, the effects of PACE-PC vs. enhanced standard care on BMI z-score. The secondary aims of this study will be assess the impact of PACE-PC on selected anthropometric measures, body fat, quality of life, metabolic and physiological manifestations of obesity, behavioral measures of diet and physical activity and a fitness test, and to model health outcomes, cost, and cost-effectiveness of the intervention. Exploratory aims will include evaluation of psychosocial mediators of behavior change, measures of depression, self esteem and body image, parental measures (including BMI) and process measures. ????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA121300-04
Application #
7637880
Study Section
Special Emphasis Panel (ZRG1-HOP-L (03))
Program Officer
Nebeling, Linda C
Project Start
2006-09-05
Project End
2011-04-30
Budget Start
2009-05-01
Budget End
2010-04-30
Support Year
4
Fiscal Year
2009
Total Cost
$519,138
Indirect Cost
Name
University of California San Diego
Department
Family Medicine
Type
Schools of Medicine
DUNS #
804355790
City
La Jolla
State
CA
Country
United States
Zip Code
92093