Primary Care, Communication, and Improving Children's Health

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern and Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Overweight school-age children

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.
Pediatrician-patient/parent communication regarding child's high weight status
Counseling regarding cardiovascular risk factor assessments/results.
Counseling regarding diet and lifestyle changes to improve weight status.
Interval follow-up to readdress weight, prior to the next well-child visit one year later. Follow-up could include ongoing care through nutrition and/or an intensive weight-management program.
Patient-centered communication will be scored as the ratio of patient to doctor-centered communication regarding weight topics. Means will be calculated for total and weight-communication-specific pediatrician, child, and parent-talk time, and patient, doctor, and the ratio of patient/doctor-centered communication scores. For the primary hypothesis, biomedical information-giving (for example, risk-factor communication) will be treated as patient-centered because the principal investigator's focus groups suggest that parents want this information, and prior research suggests that including biomedical-information giving improves the correlation of Roter's patient-centeredness measure with patient health status and satisfaction scores.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent overweight
Time Frame: 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.
From recorded well-child visit to next well-child visit, approximately 12 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI z-score
Time Frame: 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.
From recorded well-child visit to next well-child visit, approximately 12 months later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the number of "5-2-1-0" behaviors
Time Frame: From recorded well-child visit to next well-child visit, approximately 12 months later
The "5-2-1-0" behaviors are: eat five fruits and vegetables, watch "screens" (TV, computer, tablets, video games, cell phones, etc…) two hours per day or less, be physically active for one hour per day or more, and drink zero calorie-containing beverages per day.
From recorded well-child visit to next well-child visit, approximately 12 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christy B Turer, MD, MHS, University of Texas Southwestern and Children's Medical Center Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2014

Primary Completion (Actual)

August 5, 2016

Study Completion (Actual)

August 10, 2017

Study Registration Dates

First Submitted

October 27, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 29, 2014

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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