Treatment of Childhood Obesity in Primary Care
Primary Purpose
Obesity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing (physicians)
Behavior Modification (families)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Children, Behavioral, Motivational, Family, Primary care
Eligibility 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
Sites / Locations
- Group Health East Pediatrics
- UW East Pediatric Clinic
- University Station Pediatrics
- UW Pediatrics-Park St.
- UW West Towne Pediatrics
- Dean Pediatric Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Proportion of primary care physicians who discuss the child's BMI with parents
Secondary Outcome Measures
Basic descriptive data analysis
Statistical testing of the primary hypothesis of each aim
Statistical modeling to better understand the relationship between the outcome of interest and the intervention
Full Information
NCT ID
NCT00398359
First Posted
November 8, 2006
Last Updated
September 30, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT00398359
Brief Title
Treatment of Childhood Obesity in Primary Care
Official Title
Treatment of Childhood Obesity in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
Increase physician recognition of risk factors for overweight.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Overweight, Children, Behavioral, Motivational, Family, Primary care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (physicians)
Intervention Description
Identifying and referring children with BMI >93%.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Modification (families)
Intervention Description
Group meetings and individual family meetings based on behavior modification for healthy lifestyle changes.
Primary Outcome Measure Information:
Title
Proportion of primary care physicians who discuss the child's BMI with parents
Time Frame
6/2007 - ongoing
Secondary Outcome Measure Information:
Title
Basic descriptive data analysis
Time Frame
two years
Title
Statistical testing of the primary hypothesis of each aim
Time Frame
two years
Title
Statistical modeling to better understand the relationship between the outcome of interest and the intervention
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen R. Wald, M.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health East Pediatrics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
Facility Name
UW East Pediatric Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
Facility Name
University Station Pediatrics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
UW Pediatrics-Park St.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States
Facility Name
UW West Towne Pediatrics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Dean Pediatric Clinic
City
Sun Prairie
State/Province
Wisconsin
ZIP/Postal Code
53590
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12192190
Citation
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. doi: 10.1097/00005176-200208002-00019. No abstract available.
Results Reference
background
Citation
Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition. New York: Guilford Press; 2002.
Results Reference
background
Citation
Rollnick S, Mason P, Butler C. Health Behavior Change: A guide for practitioners. Edinburgh: Churchill Livingstone; 1999.
Results Reference
background
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Treatment of Childhood Obesity in Primary Care
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