Projects: Pediatric Obesity
 
This 12-month randomized controlled trial, sponsored by NIH, aims to reduce BMI in obese adolescents (ages 11 -13) by intervening on physical activity and nutrition behaviors within primary care settings.  

PACE-PC is a theory-based stepped care program that enables pediatricians and primary care providers to intervene with obese adolescents to improve their anthropometric, metabolic, physiological, behavioral, and quality of life outcomes over a one-year period. The program integrates clinician counseling, health educator counseling, and phone and mail contact.  It supports tailoring to the needs of obese adolescents and family members and promotes improved diet and physical activity behaviors, weight loss, and ultimately weight loss maintenance.

Participants will be randomly assigned to the Enhanced Usual Care or the PACE-PC stepped care condition.  

Enhanced Standard Care includes:

•	initial visit and counseling by a physician
•	3 visits with a health educator
•	materials on how to improve weight related behaviors

PACE-PC Stepped Care includes 3 steps (each lasting 4 months), with the first step being the most intensive:
Step 1:  
•	physician visit
•	monthly health educator visits
•	biweekly phone counseling
•	weekly dissemination of nutrition and physical activity information

Step 2:  
•	health educator visits every other month
•	biweekly phone counseling
•	weekly dissemination of nutrition and physical activity information

Step 3:  
•	monthly phone counseling
•	weekly dissemination of nutrition and physical activity information

Participants randomized to the PACE-PC condition will be enrolled in Step 1 (the most intensive) for the first 4 months.  Depending upon response at the end of Step 1, for the next 4 months adolescents will be triaged to Step 2 (less intensive) or will repeat Step 1.  At 8 months, again based upon treatment response, triage will occur to either Step 3 (least intensive) or repetition of the previous step. 

Adolescent and parent/guardian participants are measured at baseline, 4 months, 8 months, and 12 months.  The primary outcome of this study is to compare at 12 months, the effects of the PACE-PC intervention and enhanced standard care on BMI z-score among obese (≥ 95 percentile for age) male and female adolescents aged 11 -13.  Secondary outcomes will be:  1)  anthropometric measures (BMI, waist circumference, body fat); 2) metabolic and physiological manifestations of obesity (fasting insulin, fasting blood glucose and blood lipid levels); 3) behavioral measurement of diet and physical activity [energy intake, percent of energy from dietary fat, fruit/vegetables/fiber consumption, total energy expenditure (kilocalories/kg/day), minutes of moderate and vigorous physical activity, sedentary behaviors/recreational media use; fitness measure (PACER)]; 4) assessment of model health outcomes, cost.  Exploratory outcomes include evaluation of psychosocial mediators of behavior change, measures of depression, self esteem and body image, parental measure (including BMI) and process measures. intervention components.