Treatment of Childhood Obesity in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398359
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : October 2, 2015
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This project will apply the concepts from the Chronic Care Model to the problem of pediatric obesity and proposes: 1) to assess the effectiveness of teaching primary care providers (in diverse practice settings) to use specific communication strategies with parents of overweight and obese children to help them take steps with their child toward healthy behavior change; 2) to offer core components of an efficacious evidence-based pediatric obesity treatment within the pediatric primary care setting to determine if participating children will achieve clinically meaningful weight loss (assessed as weight and BMI percentile changes at the end of treatment and at a six month follow-up); and 3) to assess the ability of trained, behavioral psychologists to offer the treatment so that desired child outcomes are achieved. The primary project outcomes will include: 1) increase in self-reported physician confidence in use of counseling skills related to pediatric overweight; and 2) change in child's diet, physical activity, weight and BMI percentile at the end of treatment and at 6-month follow-up.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Motivational Interviewing (physicians) Behavioral: Behavior Modification (families) Phase 3

Detailed Description:

Overweight in children, adolescents and adults has increased dramatically during the last two decades in developed and developing nations, leading to a global epidemic. Current trends in childhood overweight are a function of both poor nutrition and an increase in sedentary activities.

Pediatric health care providers are ideally situated to address this problem, especially since children are seen frequently for preventive care during the early years when intervention may be more likely to yield long-term change. However, most pediatric providers do not have the needed training to manage obesity effectively. This project will use the chronic care model to foster the effectiveness of an office-based intervention aimed at altering dietary intake and physical activity for children whose BMI reflects overweight and their parents. With the support of the health care system (through new reimbursement strategies), office redesign (assignment of tasks to the health assistant, physician and behavioral interventionist), self-management techniques (patient training) and enhanced community resources, a successful program for improved nutrition and physical activity will be built.

Specific Aim 1 of this study is to increase physician use of counseling techniques that are effective in promoting positive behavior change regarding nutrition and physical activity in the pediatric primary care setting. This aim will be accomplished by offering a training intervention for primary care pediatricians and health assistants. The intervention will:

  1. Increase physician recognition of risk factors for overweight.
  2. Teach physicians to use brief motivational strategies with parents and children that will assist them in taking steps toward healthier behavior as it relates to nutrition and physical activities, including but not limited to enrolling in a group behavioral treatment program.

Specific Aim 2 is to assess the effectiveness of implementing a pediatric primary care office-based nutrition/physical activity behavioral intervention for overweight and obese children and their parents.

In specific aim 2 we will employ trained behavioral interventionists to offer a family-based behavioral intervention targeting healthy eating and decreased sedentary behavior/increased physical activity to overweight/obese children ages 9-12 and their parents; and to evaluate parent and child adherence to attendance and behavioral intervention factors. Self-monitoring reports of the child's behavioral changes (e.g., decrease in number of "red foods"[foods high in calories and fat] consumed weekly and decreased time spent each week watching TV, using the computer, and playing video games) will be described, as will any changes in BMI.

Experienced behavioral interventionists will be trained in behavioral theory principles fundamental to the intervention that involve helping children and their parents to change behavior and maintain the changes by Dr. Ewing (Co-Investigator). Dr Ewing, who has completed Human Subjects and HIPAA training at the University of Pittsburgh will come to Madison, Wisconsin to do a training session for the behavioral interventionists and study coordinator. In addition, she will provide instruction in principles of weight management, the role of healthy eating and physical activity in maintaining a healthy weight, and the empirical support for the intervention that will be offered. Finally, the interventionists will receive training to conduct each of the individual sessions.

The American Academy of Pediatrics (AAP) recommends that overweight children be screened for fasting blood glucose, fasting blood insulin, and serum lipids. Pre and post lab values that are available for participating children will be recorded.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Childhood Obesity in Primary Care
Study Start Date : May 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1 Behavioral: Motivational Interviewing (physicians)
Identifying and referring children with BMI >93%.
Behavioral: Behavior Modification (families)
Group meetings and individual family meetings based on behavior modification for healthy lifestyle changes.

Primary Outcome Measures :
  1. Proportion of primary care physicians who discuss the child's BMI with parents [ Time Frame: 6/2007 - ongoing ]

Secondary Outcome Measures :
  1. Basic descriptive data analysis [ Time Frame: two years ]
  2. Statistical testing of the primary hypothesis of each aim [ Time Frame: two years ]
  3. Statistical modeling to better understand the relationship between the outcome of interest and the intervention [ Time Frame: two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • >95% BMI
  • developmentally normal
  • referred by primary care provider

Exclusion Criteria:

  • currently involved in an organized weight control program
  • Preexisting high blood pressure
  • Preexisting high lipids
  • Preexisting diabetes due to obesity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398359

United States, Wisconsin
Group Health East Pediatrics
Madison, Wisconsin, United States, 53704
UW East Pediatric Clinic
Madison, Wisconsin, United States, 53704
University Station Pediatrics
Madison, Wisconsin, United States, 53705
UW Pediatrics-Park St.
Madison, Wisconsin, United States, 53713
UW West Towne Pediatrics
Madison, Wisconsin, United States, 53717
Dean Pediatric Clinic
Sun Prairie, Wisconsin, United States, 53590
Sponsors and Collaborators
University of Wisconsin, Madison
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Ellen R. Wald, M.D. University of Wisconsin, Madison

Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition. New York: Guilford Press; 2002.
Rollnick S, Mason P, Butler C. Health Behavior Change: A guide for practitioners. Edinburgh: Churchill Livingstone; 1999.

Responsible Party: University of Wisconsin, Madison Identifier: NCT00398359     History of Changes
Other Study ID Numbers: M-2006-1018
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: December 2011

Keywords provided by University of Wisconsin, Madison:
Primary care

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms