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Sponsors and Collaborators: |
University of Wisconsin, Madison Agency for Healthcare Research and Quality (AHRQ) |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00398359 |
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 | Intervention | Phase |
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Obesity |
Behavioral: Motivational Interviewing (physicians) Behavioral: Behavior Modification (families) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Childhood Obesity in Primary Care |
Estimated Enrollment: | 150 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
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.
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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:
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.
Ages Eligible for Study: | 9 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |
Dean Pediatric Clinic | |
Sun Prairie, Wisconsin, United States, 53590 | |
UW West Towne Pediatrics | |
Madison, Wisconsin, United States, 53717 | |
University Station Pediatrics | |
Madison, Wisconsin, United States, 53705 | |
UW Pediatrics-Park St. | |
Madison, Wisconsin, United States, 53713 | |
Group Health East Pediatrics | |
Madison, Wisconsin, United States, 53704 | |
UW East Pediatric Clinic | |
Madison, Wisconsin, United States, 53704 |
Principal Investigator: | Ellen R. Wald, M.D. | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin-Madison ( Ellen R. Wald, MD ) |
Study ID Numbers: | M-2006-1018 |
Study First Received: | November 8, 2006 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00398359 |
Health Authority: | United States: Institutional Review Board |
Obesity Overweight Children Behavioral |
Motivational Family Primary care |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overnutrition Overweight |