Treatment of Childhood Obesity in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ellen R Wald, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00398359
First received: November 8, 2006
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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
Obesity
Behavioral: Motivational Interviewing (physicians)
Behavioral: Behavior Modification (families)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Childhood Obesity in Primary Care

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Proportion of primary care physicians who discuss the child's BMI with parents [ Time Frame: 6/2007 - ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Basic descriptive data analysis [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Statistical testing of the primary hypothesis of each aim [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Statistical modeling to better understand the relationship between the outcome of interest and the intervention [ Time Frame: two years ] [ Designated as safety issue: No ]

Enrollment: 145
Study Start Date: May 2006
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398359

Locations
United States, Wisconsin
Group Health East Pediatrics
Madison, Wisconsin, United States, 53704
University Station Pediatrics
Madison, Wisconsin, United States, 53705
UW East Pediatric Clinic
Madison, Wisconsin, United States, 53704
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
Investigators
Principal Investigator: Ellen R. Wald, M.D. University of Wisconsin, Madison
  More Information

Publications:
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: Ellen R Wald, MD, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00398359     History of Changes
Other Study ID Numbers: M-2006-1018
Study First Received: November 8, 2006
Last Updated: December 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Obesity
Overweight
Children
Behavioral
Motivational
Family
Primary care

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

ClinicalTrials.gov processed this record on October 21, 2014