Primary Care, Communication, and Improving Children's Health

Completed

• Conditions: Weight Loss; Childhood Obesity; Overweight; Communication
• Interventions: Other: Communication regarding overweight status; Other: Risk-factor assessment and counseling; Other: Lifestyle behavior assessment and counseling; Other: Interval follow-up to readdress weight; Other: Patient-centered 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overweight school-age children	Interval follow-up to readdress weight	Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded. The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include: 1. Communication regarding child's high weight status 2. Counseling regarding cardiovascular risk factor screening and assessment 3. Behavioral counseling 4. Interval follow-up to readdress weight, and 5. Patient-centeredness, scored as the ratio of patient to doctor-centered communication regarding weight topics.
Overweight school-age children	Communication regarding overweight status	Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded. The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include: 1. Communication regarding child's high weight status 2. Counseling regarding cardiovascular risk factor screening and assessment 3. Behavioral counseling 4. Interval follow-up to readdress weight, and 5. Patient-centeredness, scored as the ratio of patient to doctor-centered communication regarding weight topics.
Overweight school-age children	Lifestyle behavior assessment and counseling	Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded. The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include: 1. Communication regarding child's high weight status 2. Counseling regarding cardiovascular risk factor screening and assessment 3. Behavioral counseling 4. Interval follow-up to readdress weight, and 5. Patient-centeredness, scored as the ratio of patient to doctor-centered communication regarding weight topics.
Overweight school-age children	Risk-factor assessment and counseling	Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded. The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include: 1. Communication regarding child's high weight status 2. Counseling regarding cardiovascular risk factor screening and assessment 3. Behavioral counseling 4. Interval follow-up to readdress weight, and 5. Patient-centeredness, scored as the ratio of patient to doctor-centered communication regarding weight topics.
Overweight school-age children	Patient-centered communication	Overweight 6-12 year-old children. Weight status will be measured and parents complete surveys at baseline and one year later. Pediatricians will complete surveys at baseline, and after index visit. Visits will be directly video-recorded. The impact of pediatrician clinical practices and communication strategies on child's weight status will be evaluated at one year. Clinical practices (such as risk-factor screening) that occur during the 1-year interval between well-child visits also will be assessed. Specific clinical practice elements and communication strategies that will be examined include: 1. Communication regarding child's high weight status 2. Counseling regarding cardiovascular risk factor screening and assessment 3. Behavioral counseling 4. Interval follow-up to readdress weight, and 5. Patient-centeredness, scored as the ratio of patient to doctor-centered communication regarding weight topics.

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