Clinical trial NCT02277899: Primary Care, Communication, and Improving Children's Health
Official title: Primary Care, Communication, and Improving Children's Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Overweight
Communication
Weight Loss
Keywords: childhood obesity
overweight
communication
primary care
weight management
communication methods
patient-centered communication
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit pediatricians (from academic, community, and private practices), children, and a consenting parent. Pediatricians and children will be selected to reflect the proportions of minority pediatricians and children in the practices. Pediatricians at the community and private practices will be eligible to participate if they provide outpatient pediatric care ≥20 hours/week. At the academic clinic, only second and third-year residents will be eligible. Eighty-five children and a consenting parent will be recruited.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent overweight
timeFrame: From recorded well-child visit to next well-child visit, approximately 12 months later
Secondary outcomes:
measure: BMI z-score
timeFrame: From recorded well-child visit to next well-child visit, approximately 12 months later
Other outcomes:
measure: Change in the number of "5-2-1-0" behaviors
timeFrame: From recorded well-child visit to next well-child visit, approximately 12 months later
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern and Children's Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern and Children's Medical Center Dallas
name: Christy B Turer, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turer CB, Montano S, Lin H, Hoang K, Flores G. Pediatricians' communication about weight with overweight Latino children and their parents. Pediatrics. 2014 Nov;134(5):892-9. doi: 10.1542/peds.2014-1282. Epub 2014 Oct 13.
citation: Turer CB, Mehta M, Durante R, Wazni F, Flores G. Parental perspectives regarding primary-care weight-management strategies for school-age children. Matern Child Nutr. 2016 Apr;12(2):326-38. doi: 10.1111/mcn.12131. Epub 2014 Apr 10.
citation: Upperman C, Palmieri P, Lin H, Flores G, Turer CB. What do parents want for their children who are overweight when visiting the paediatrician? Obes Sci Pract. 2015 Oct;1(1):33-40. doi: 10.1002/osp4.5. Epub 2015 Sep 10.
citation: Turer CB, Upperman C, Merchant Z, Montano S, Flores G. Primary-Care Weight-Management Strategies: Parental Priorities and Preferences. Acad Pediatr. 2016 Apr;16(3):260-6. doi: 10.1016/j.acap.2015.09.001. Epub 2015 Sep 26.
citation: Turer CB, Barlow SE, Montano S, Flores G. Discrepancies in Communication Versus Documentation of Weight-Management Benchmarks: Analysis of Recorded Visits With Latino Children and Associated Health-Record Documentation. Glob Pediatr Health. 2017 Feb 6;4:2333794X16685190. doi: 10.1177/2333794X16685190. eCollection 2017.