PACE-PC: Primary Care Management of Adolescent Obesity - Full Text View

Sponsored by:	University of California, San Diego
Information provided by:	University of California, San Diego
ClinicalTrials.gov Identifier:	NCT00415974

Purpose

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.

Condition	Intervention
Obesity Overweight Weight Loss Weight Maintenance	Behavioral: Physician Counseling Behavioral: Health Educator Behavioral: Phone Counseling Behavioral: Health promotion materials on physical activity and nutrition

MedlinePlus related topics: Obesity Obesity in Children Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	PACE-PC: Primary Care Management of Adolescent Obesity

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

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Secondary: 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

Estimated Enrollment:	110
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2011

Show Detailed Description

Eligibility

Ages Eligible for Study:	11 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415974

Contacts

Contact: Jill Rybar, MPH	858-457-7280
Contact: Isabella Parkinson, MA	858-457-7280

Locations

United States, California
UCSD La Jolla Building
La Jolla, California, United States, 92037

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator:

Kevin Patrick, MD, MS

UCSD

More Information

Pace Project Web Site This link exits the ClinicalTrials.gov site

Study ID Numbers:	1 R01 CA121300-01
Study First Received:	December 26, 2006
Last Updated:	December 26, 2006
ClinicalTrials.gov Identifier:	NCT00415974
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Diego:

Weight Loss
Obesity
Overweight
Physical Activity
Nutrition

Primary Care Physicians
Primary Care
Counseling
Adolescent

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 16, 2009