Primary Care, Communication, and Improving Children's Health

Completed

• Conditions: Weight Loss; Childhood Obesity; Overweight; Communication

• Registration Number: NCT02277899
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The purpose of this study is to determine communication content and strategies in primary care that predict improvement in weight status among overweight school-age children.

Detailed Description

We will test whether 1) pediatrician-patient communication regarding overweight status, behavior/risk-factor counseling, and the frequency and time to next follow-up visit, compared with either no communication or incomplete communication (communicating only high weight status without behavior/risk-factor counseling or a follow-up visit) will predict improvement in weight status at one year follow-up, and 2) during pediatrician-patient communication regarding weight and weight management, higher patient-centeredness will predict improvement in weight status at one year follow-up. The communication content identified will generate new information about the most effective content and style of pediatrician-patient communication that predict weight-status improvement. Because we prospectively will examine clinical practice elements in the one-year interval between well-child visits, acknowledging that communication regarding high weight status may initiate assessment of risk factors for heart disease (such as high cholesterol and blood sugar), more frequent follow-up visits, or prompt a nutrition referral, we will generate novel information about the most effective clinical practices and follow-up interval and frequency that predict weight-status improvement in overweight children. We also will examine if the content and style of communication are related to improvements in diet and lifestyle behaviors at one-year follow-up.

Study Timeline

• Study Start: 2014-10-14
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-29
• Primary Completion: 2016-08-05
• Study Completion: 2017-08-10
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Schedule a well-child visit with a participating pediatrician
• Agree to return in one year for the follow-up well-child visit
• Overweight
• 6-12 years old
• Have a working telephone and/or e-mail address
• Child/parent willing to provide assent/consent

Exclusion Criteria

• Unstable illness (such as uncontrolled asthma)
• Developmental condition (such as trisomy 21)
• Planning to move/leave practice within two years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent overweight	From recorded well-child visit to next well-child visit, approximately 12 months later	The percent over the median BMI percentile for age and gender. This measure changes comparably for similar weight changes in overweight and severely-obese children. In contrast, an overweight child would have to lose substantially less weight than a severely-obese child for the same change in BMI z-score.

Secondary Outcome Measures

Name	Time	Method
BMI z-score	From recorded well-child visit to next well-child visit, approximately 12 months later	Change in BMI z-score of 0.25-0.5 has been associated with reductions in cardiovascular-disease risk factors. Using both percent overweight and BMI z-score measures will allow examination of the relationship between relative weight changes and cardiovascular-disease risk-factor improvement.

Trial Locations

Locations (1)

University of Texas Southwestern and Children's Medical Center; 🇺🇸 Dallas, Texas, United States