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Completed

NCT Number: NCT02277899

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.

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Key information

Conditions

Childhood Obesity Behavior Body Weight Body Weight Changes Communication Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Weight Loss

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern and Children's Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communication regarding overweight status

Other

Pediatrician-patient/parent communication regarding child's high weight status

Risk-factor assessment and counseling

Other

Counseling regarding cardiovascular risk factor assessments/results.

Lifestyle behavior assessment and counseling

Other

Counseling regarding diet and lifestyle changes to improve weight status.

Interval follow-up to readdress weight

Other

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

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 29, 2014
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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