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NCT00415974 · ClinicalTrials.gov registry record · NA
PACE-PC: Primary Care Management of Adolescent Obesity
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 106
- Enrollment target
NCT00415974 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 106 participants.
The verdict
NCT00415974, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
Study 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 repetit
Interventions
- BEHAVIORAL Phone Counseling
- BEHAVIORAL Physician Counseling
- BEHAVIORAL Health Educator
- BEHAVIORAL Health promotion materials on physical activity and nutrition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00415974
The ClinicalTrials.gov registry entry for NCT00415974 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Phone Counseling is the first listed.
NCT00415974 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00415974 about?
NCT00415974 is a clinical study titled "PACE-PC: Primary Care Management of Adolescent Obesity". 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...
What is the current status of trial NCT00415974?
This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2008-02. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00415974?
The interventions under investigation include: Phone Counseling (BEHAVIORAL), Physician Counseling (BEHAVIORAL), Health Educator (BEHAVIORAL), Health promotion materials on physical activity and nutrition (BEHAVIORAL).
Who is sponsoring clinical trial NCT00415974?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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