CompletedNot Applicable

PACE-PC: Primary Care Management of Adolescent Obesity

United States106 participantsStarted 2008-02

Plain-language summary

This 12-month randomized controlled trial, sponsored by NIH/NCI, 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. The Enhanced Standard Care condition includes an initial visit and counseling by a physician, 3 visits with a health educator, and materials on how to improve weight related behaviors. The PACE-PC Stepped Care condition includes 3 steps (each lasting 4 months), with the first step being the most intensive: Step 1 includes: a physician visit, monthly health educator visits, biweekly phone counseling, and weekly dissemination of nutrition and physical activity information Step 2 includes: a health educator visits every other month, biweekly phone counseling, and weekly dissemination of nutrition and physical activity information Step 3 includes: monthly phone counseling and 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.

Who can participate

Age range11 Years – 13 Years

SexALL

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Inclusion Criteria: * Males and Females, ages 11-13 who are obese (\> 95% Body Mass Index for age and gender). Participants must have: * a home telephone and permanent residence with the intent to stay in the San Diego area over the entire study period; * willingness to return to the pediatrician for counseling sessions; * ability to attend measurement visits at the PACE research office. Exclusion Criteria: * Any prospective participant with any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, obesity hypoventilation syndrome, and orthopedic problems will be excluded from the study. * Additionally, participants will also be excluded if they are over 285 pounds (limits of DXA machine), have any pulmonary, cardiovascular or musculoskeletal problem that would limit ability to comply with moderate-level physical activity (e.g. walking), have a history of substance abuse, or other psychiatric disorder that would impair compliance with the study protocol, or are using any medications which alter body weight. * Patients in foster care will be ineligible due to difficulty in obtaining follow-up measures should they move from home to home.

What they're measuring

Primary: 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.

Timeframe: baseline, 4 months, 8 months, 12 months

Trial details

NCT IDNCT00415974

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-02