Treatment of Childhood Obesity in Primary Care

Obesity Clinical Trial

Official title:

Treatment of Childhood Obesity in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398359
• Other study ID #: M-2006-1018
• Status: Completed
• Phase: Phase 3
• First received: November 8, 2006
• Last updated: September 30, 2015
• Start date: May 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Group Health East Pediatrics	Madison	Wisconsin
United States	University Station Pediatrics	Madison	Wisconsin
United States	UW East Pediatric Clinic	Madison	Wisconsin
United States	UW Pediatrics-Park St.	Madison	Wisconsin
United States	UW West Towne Pediatrics	Madison	Wisconsin
United States	Dean Pediatric Clinic	Sun Prairie	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Koletzko B, Girardet JP, Klish W, Tabacco O. Obesity in children and adolescents worldwide: current views and future directions--Working Group Report of the First World Congress of Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2002;35 Suppl 2:S205-12. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of primary care physicians who discuss the child's BMI with parents		6/2007 - ongoing	No
Secondary	Basic descriptive data analysis		two years	No
Secondary	Statistical testing of the primary hypothesis of each aim		two years	No
Secondary	Statistical modeling to better understand the relationship between the outcome of interest and the intervention		two years	No