PACE-PC: Primary Care Management of Adolescent Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin Patrick, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00415974
First received: December 26, 2006
Last updated: August 15, 2012
Last verified: August 2012
  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
Behavioral: Physician Counseling
Behavioral: Health Educator
Behavioral: Phone Counseling
Behavioral: Health promotion materials on physical activity and nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PACE-PC: Primary Care Management of Adolescent Obesity

Resource links provided by NLM:


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. [ Time Frame: baseline, 4 months, 8 months, 12 months ] [ Designated as safety issue: No ]

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 [ Time Frame: baseline, 4 mos, 8 mos, 12 mos ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: February 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Enhanced Usual Care
Enhanced Usual Care Arm: This group will receive 2 face-to-face sessions with a health educator for dietary and health counseling in addition to an initial physician-patient visit. Educational materials that a patient might receive at his/her physician's office will also be provided at the initial health educator visit and monthly thereafter. This condition is called "Enhanced Standard Care" because it is, in fact, more than most obese adolescents currently receive in primary care offices in San Diego.
Behavioral: Physician Counseling
Physician-patient visits will occur in the primary care setting and are scheduled at study onset (beginning of step 1) and at the end of the first year. An extra physician visit will occur for patients who do not progress from step 1 after two attempts. At study entry, physicians will discuss the purpose and importance of the intervention and encourage participation. Physicians will underline the value of attending all study visits and complying with study protocol and instructions. Subsequent physician visits will focus on weight loss progress and overcoming barriers.
Behavioral: Health Educator
Health education sessions are held with teens and parents at the primary care setting. These include information on nutrition, physical activity, and weight loss. Behavioral approaches are used to enhance the home environment, food preparation, and planned physical activity to elicit weight loss, including discovery of perceived and actual barriers to modification of eating and physical activity behaviors. The Health Educator focuses on problem-solving and tailored selection of behavior change skills to help participants overcome difficulties. In addition to reviewing the assessment and generating solutions to barriers, sample meal plans (including strategies for restricting calories) and pedometers will be distributed at the initial health educator visit. Pedometers are encouraged to monitor progress with physical activity goals. An initial binder is distributed to teen and parent participants at the initial session and subsequent materials are added with each visit.
Behavioral: Health promotion materials on physical activity and nutrition
PACE-PC adolescents and their families will receive information regarding healthy eating and physical activity behaviors on a weekly basis via mail. These behavioral-based materials will educate participants and their families on healthy behaviors that are necessary for successful weight management. Topics will coincide with the intervention goals and include supplemental information to enhance quality of life and improve body image. Topics will include realistic goal-setting and attainment, how to handle holidays and celebrations, eating fast food, grocery shopping and food preparation, and relapse prevention, etc.. Topics will include specific strategies related to the adolescent's readiness to change to reflect processes that are most appropriate. Content from these materials will be addressed by the phone counselors to ensure that participants received and understood intervention messages.
Experimental: Stepped Care

PACE-PC is a 1-year stepped-care intervention (subdivided into three 4-month blocks) utilizing multiple modalities including clinician and tailored health educator counseling, phone counseling, mailed content for overweight adolescents and their family to promote improved diet and physical activity behaviors aimed at weight loss and weight loss maintenance.

PACE-PC is designed to be based in the primary care setting and promotes involvement, management, and decision-making by the primary care provider about the level of PACE-PC step for each enrolled patient

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.

Behavioral: Physician Counseling
Physician-patient visits will occur in the primary care setting and are scheduled at study onset (beginning of step 1) and at the end of the first year. An extra physician visit will occur for patients who do not progress from step 1 after two attempts. At study entry, physicians will discuss the purpose and importance of the intervention and encourage participation. Physicians will underline the value of attending all study visits and complying with study protocol and instructions. Subsequent physician visits will focus on weight loss progress and overcoming barriers.
Behavioral: Health Educator
Health education sessions are held with teens and parents at the primary care setting. These include information on nutrition, physical activity, and weight loss. Behavioral approaches are used to enhance the home environment, food preparation, and planned physical activity to elicit weight loss, including discovery of perceived and actual barriers to modification of eating and physical activity behaviors. The Health Educator focuses on problem-solving and tailored selection of behavior change skills to help participants overcome difficulties. In addition to reviewing the assessment and generating solutions to barriers, sample meal plans (including strategies for restricting calories) and pedometers will be distributed at the initial health educator visit. Pedometers are encouraged to monitor progress with physical activity goals. An initial binder is distributed to teen and parent participants at the initial session and subsequent materials are added with each visit.
Behavioral: Phone Counseling
Brief counseling calls will occur between PACE-PC participants and assigned counselors during all steps. In general, these calls occur on a bi-weekly to monthly basis in steps 1 and 2, and monthly in step 3. Such calls are intended to encourage continued goal attainment and progression and to promote healthy eating and physical activity behaviors. Counselors will review progress since the last clinical interaction (e.g., health educator visit, phone call, or physician visit) and help adolescents set new goals that are appropriate and attainable. Data from pedometers may be discussed during these sessions as an interim assessment of progress on physical activity behaviors between formal study measurement visits. After speaking with the adolescent, the counselor will talk with the parent (when feasible) to reinforce parental involvement and emphasize the importance of the healthy changes in the home environment to encourage goal attainment.
Behavioral: Health promotion materials on physical activity and nutrition
PACE-PC adolescents and their families will receive information regarding healthy eating and physical activity behaviors on a weekly basis via mail. These behavioral-based materials will educate participants and their families on healthy behaviors that are necessary for successful weight management. Topics will coincide with the intervention goals and include supplemental information to enhance quality of life and improve body image. Topics will include realistic goal-setting and attainment, how to handle holidays and celebrations, eating fast food, grocery shopping and food preparation, and relapse prevention, etc.. Topics will include specific strategies related to the adolescent's readiness to change to reflect processes that are most appropriate. Content from these materials will be addressed by the phone counselors to ensure that participants received and understood intervention messages.

  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

Locations
United States, California
UCSD - CALIT2- Atkinson Hall
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Kevin Patrick, MD, MS UCSD
  More Information

Additional Information:
No publications provided

Responsible Party: Kevin Patrick, MD, MS, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00415974     History of Changes
Other Study ID Numbers: 1 R01 CA121300-01
Study First Received: December 26, 2006
Last Updated: August 15, 2012
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

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 15, 2014