Treatment of Childhood Obesity in Primary Care

NCT00398359 | Completed Phase 3

• 1 other identifier: M-2006-1018
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 6

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.

Conditions

Obesity

Keywords

Obesity; Overweight; Children; Behavioral; Motivational; Family; Primary care

Outcome Measures

Primary Outcomes (1)

• Proportion of primary care physicians who discuss the child's BMI with parents

  6/2007 - ongoing

Secondary Outcomes (3)

• Basic descriptive data analysis

  two years

• Statistical testing of the primary hypothesis of each aim

  two years

• Statistical modeling to better understand the relationship between the outcome of interest and the intervention

  two years

Study Arms (1)

1

EXPERIMENTAL

Behavioral: Motivational Interviewing (physicians); Behavioral: Behavior Modification (families)

Interventions

Motivational Interviewing (physicians) BEHAVIORAL

Identifying and referring children with BMI \>93%.

1

Behavior Modification (families) BEHAVIORAL

Group meetings and individual family meetings based on behavior modification for healthy lifestyle changes.

1

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (6)

Group Health East Pediatrics

Madison, Wisconsin, 53704, United States

Location

UW East Pediatric Clinic

Madison, Wisconsin, 53704, United States

Location

University Station Pediatrics

Madison, Wisconsin, 53705, United States

Location

UW Pediatrics-Park St.

Madison, Wisconsin, 53713, United States

Location

UW West Towne Pediatrics

Madison, Wisconsin, 53717, United States

Location

Dean Pediatric Clinic

Sun Prairie, Wisconsin, 53590, United States

Location

Related 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. doi: 10.1097/00005176-200208002-00019. No abstract available.

  PMID: 12192190 BACKGROUND

• Miller WR, Rollnick S. Motivational Interviewing: Preparing People for Change. 2nd edition. New York: Guilford Press; 2002.

  BACKGROUND

• Rollnick S, Mason P, Butler C. Health Behavior Change: A guide for practitioners. Edinburgh: Churchill Livingstone; 1999.

  BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Behavior

Interventions

Motivational Interviewing; Physicians; Behavior Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Health Personnel; Psychotherapy

Study Officials

• Ellen R. Wald, M.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2006
• First Posted: November 10, 2006
• Study Start: May 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 2, 2015

Record last verified: 2011-12

Locations

US (6)